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Download white papers created by the Society for Clinical Research Sites (SCRS), which share valuable insights into critical topics for research site sustainability and stronger industry partnerships. These industry-leading white papers provide timely information that can inform and empower decision-making for more collaborative and efficient clinical research.

2023 Site Landscape Survey White Paper

The SCRS Site Landscape Survey shows a comprehensive look at what’s impacting site success from year to year and the impact on the broader life sciences industry. Reflecting the current pulse of the industry, this year’s survey shares insights related to clinical technology and innovation, participant diversity and inclusion, site financial health, and record retention. This report serves as a tool for sites and industry organizations to optimize their approaches to trial design and implementation for more productive, effective, and efficient studies.

Workforce Challenges at Clinical Research Sites

Since the COVID-19 pandemic began, changing macro- and micro-economic factors have impacted all industries, and clinical research is no different. With unprecedented workforce challenges and increasing costs, clinical research sites are struggling to recruit and retain qualified staff. SCRS conducted a global survey to explore the current workforce challenges at clinical research sites and understand the impact they are having on the clinical research industry. 

2022 Site Landscape Survey

For the 10th consecutive year, SCRS conducted an annual survey to gather data about the current state of operational health at clinical research sites. The survey responses help us understand factors that are impacting sites’ success and longevity, and provide helpful insights for the life sciences industry to optimize clinical research productivity. The results offer useful insights into the evolution of clinical research from the perspective of sites, as well as a better understanding of factors that impact their operations and sustainability. This. year's survey includes data on site finances, workforce considerations, and larger trends such as decentralization and digitalization.

Site Perspectives on Decentralized Clinical Trials

While decentralized clinical trial (DCT) technologies have enabled patients and sites to participate in novel and innovative ways, there is a lack of qualitative and quantitative data from sites on their use and implementation. Medidata collaborated with SCRS to survey sites on DCT topics, aiming to gauge the impact on sites for aspects such as scope, effectiveness, and enablement. Insights into sites' experiences with DCTs will aid stakeholders in refining trial design, operations, and regulatory policies for enhanced patient and site service and global health outcomes.

2021 Site Landscape Survey

In the 2021 Site Landscape Survey, nearly 600 respondents from various roles and organizations shared insights on their operations, partnerships, finances, and experiences with technology. The results, while reflecting patterns from previous surveys, also highlight the impact of the ongoing global pandemic and newer trends in clinical research. The data underscores the effects of digitalization and globalization on clinical research sites, revealing varied outcomes such as increased revenue or declined study opportunities. Ongoing trends, like the adoption of eClinical technologies, continue to influence operational strategies. The survey offers actionable insights to enhance relationships and optimize operational health, contributing to improved collective success in clinical development.

A Pilot Study to Examine the Validity and Reliability of a Site Assessment Checklist for the Evaluation of Best Practices in Recruiting Diverse Patient Populations for Clinical Trials

Recognizing the crucial role of diverse patient populations in clinical trials, stakeholders in pharmaceutical development emphasize the need for inclusive recruitment. From this need, SCRS established a program to increase education on inclusive recruitment opportunities. The initiative also developed a 27-item checklist evaluating sites' knowledge for recruiting diverse patients for clinical trials. The checklist serves as a self-assessment tool for sites, aiding them in developing improvement action plans. This paper discusses the development and psychometric testing of the diversity assessment tool, highlighting efforts to enhance best practices in recruiting diverse patient populations for clinical trials.

Patient Centricity and Virtualizing Technologies in a COVID-19 World

How sites view the digital tools that encourage patient centricity is critically important to clinical trial stakeholders during the COVID-19 era, as decentralized trials are destined to play a larger role.  To gauge sites’ level of acceptance and knowledge about virtualizing technologies, SCRS. collaborated with Medidata to conduct an online survey.  It took place between May 19 and July 10, 2020, a meaningful timeframe as the pandemic was well underway, allowing sites to respond to questions through a “COVID lens”. The survey measured current and anticipated levels of adoption of patient-centric tools, along with the sites’ perspective on patient reactions.

Sites Speak Out on Clinical Trial Technology Overload

SCRS collaborated with IQVIA to conduct a global site-based survey focused on the expanding volume of clinical trial technologies. The survey aimed to pinpoint the burdens sites face in adopting an array of new systems, each with its own passwords and required training. The survey was conducted on the cusp of the COVID-19 pandemic, and with sponsors embracing virtual clinical trials, sites and patients will be able to remain safer by decreasing the number of visits, replacing site visits with virtual visits, and increasing remote monitoring.

Impact Assessment of Decentralized Clinical Trials (DCT) Awareness in the Clinical Research Industry

Decentralized Clinical Trials (DCTs) have the potential to provide tremendous efficiencies to the clinical trial process. However, understanding the great impact they are having on sites and the trial industry is critical to taking the appropriate steps towards implementation. In collaboration with VirTrial, SCRS embarked on a survey and publication initiative to provide this important analysis. Primary concerns and the current state of needs at the site level are centered around assuring patient safety and adequate education and understanding. This white paper expands on the value of DCTs and what needs to be done in order to prepare for them.

Impact Assessment of eClinical Technologies and Industry Initiatives on Sites

Sponsors and CROs fight a continuous uphill battle to reduce complexity, streamline business processes and workflows, ensure compliance and increase efficiencies in the pursuit of bringing drugs to market. Fundamental to this goal is a site-centric approach to conducting clinical trials. Sites are dynamic environments, and new technology and industry initiatives are important complements to the critical need for relationship-building and maintenance. But, are these technologies and initiatives helping improve site and sponsor-CRO collaboration and creating a competitive edge through improved clinical trial performance? To explore these issues and their impact, SCRS and Oracle Health Sciences surveyed clinical research site professionals around the world.

Financial Barriers to Site Sustainability, Patient Experience and Overall Trial Success

It is well-known and frequently documented that financial stress is one of the primary issues negatively impacting clinical research site success. Previous data collected by SCRS, in partnership with Greenphire, identified four major challenges affecting clinical trial success:  limited operating cash, manual invoicing processes, untimely payment frequency and lack of financial transparency are all top of mind for sites globally. However, it is important to understand that the barriers to success are not exclusively correlated to site payments. In fact, the challenges are evident throughout the life-cycle of a clinical study, as early as the study budget negotiation processes and all the way through patient engagement and payments.

Recruiting Diverse Patient Populations in Clinical Studies: Factors That Drive Site Success

As part of its Diversity Awareness Program, SCRS conducted a pilot study and survey to determine how successfully sites recruit diverse patient populations for clinical studies and to examine the factors that drive site success or lack thereof. This is the first known comprehensive study of the extent to which sites report being successful in recruiting diverse patient populations in their clinical studies and the factors related to this success. This data may help pave the way for the development of strategies sites can use to enhance their ability to recruit diverse patient populations in clinical studies.

Patient Diversity Awareness: Developing a Better Understanding of the Knowledge, Expertise, and Best Practices at Clinical Research Sites to Meet the Needs of an Increasingly Diverse United States Population

The FDA has imposed, and continually is tightening the reigns on ensuring that clinical trials enroll racially/ethnically diverse patients. This warrants bolstered safety and efficacy for the representative patient population that will be using new medical products. Sponsors are highly encouraged to obtain a diversified patient population on all trials, not just for particular therapeutic indications. In this pilot study, site interviews were implemented to identify factors that affect the enrollment of diverse patient populations in clinical research trials. Future efforts to increase site awareness and best practices for inclusion of diverse patient populations in clinical research must therefore target issues that matter most to sites and patients to benefit society overall resulting in increased patient diversity within clinical trials.

Site Budget Development and Payment Systems: A Call for Transparency from Clinical Research Sites

SCRS research outlines the role technology innovations have on the power to bring transparency and efficiency to the site payment and budget process, however, legacy processes and practices fail to embrace these solutions. This white paper explores potential solutions and reports on site responses identifying features they would find to be the most valuable, providing a potential road map for industry partners to use in addressing these concerns.

Why Is Clinical Source Data Still Collected on Paper?

This white paper builds on data from the Research Site Source Survey, reporting that paper source document creation is a task completed at many sites at significant expense and risk to quality. This task continues despite widespread adoption of electronic medical records and the development of a regulatory framework for eSource. In this paper, the task of paper source document creation and transcription is explored and the total cost calculated.

Site Payments and Patient Reimbursements: A Global Perspective

This white paper presents global data on site perspectives on payments and patient reimbursement. The white paper validates SCRS advocacy for key improvement from payers. It also demonstrates a complex relationship between payment processes to sites and patient payments, linking these key improvements to the patient experience.

Meeting Clinical Trial Site Needs with Patient Recruitment Agency Services White Paper

Innovation in how patients and clinical trials are brought together is urgently needed. Recruitment that takes longer than expected increases the costs of products and prevents new products from being brought to market. Too many studies are canceled because recruitment is never completed. This white paper presents information collected from clinical research sites in the US and five European countries and provides new insights into factors holding back patient recruitment innovation and how they can be overcome.

CLEAR (Common Language Evaluation and Reconciliation) White Paper

The purpose of Common Language Evaluation and Reconciliation (CLEAR) is to streamline contract negotiations and thereby accelerate site initiations, leading to increased recruitment timeliness and reduced study start-up costs. Improving productivity by reducing cycle times and accelerating clinical research will allow industry to get new treatments in development to patients faster without sacrificing quality. This initiative benefits all the stakeholders within industry — sponsors, CROs, and sites — but most importantly patients.

Site Study Dashboard White Paper

What if sponsors had a standardized process for sharing information about sites in the form of a Site Study Dashboard? Sponsors have this information readily available. Sites want a dashboard that reflects their performance. This paper lays out nine key metrics that can be shared with sites and the methodology of how the data can be shared to enhance the relationship with the site. It also provides insight into the format of data that sites are most likely to find meaningful.

Site Payment White Paper

This paper documents five burdens the current site payment structure places on sites and solutions to address these issues. Additionally, the paper outlines further burdens that will be examined over 2016-2017 by the SCRS payment initiative working group.

The Approach of Protocol Training on Clinical Trial Quality White Paper

In an era of increasing protocol complexity, growing Investigator complaints and inspections, higher Investigator turnover and the focus on quality by design, it is becoming more important than ever to ensure investigative sites are adequately trained to deliver high-quality data. The growing number of FDA findings related to failure to follow the investigational plan should be a call to action for sponsors, CROs and investigative sites alike to pursue a quest for “zero defects.” Whether this trend is related to increased protocol complexity, the higher number of less experienced Investigators participating in clinical trials, the protocol training approach or some other combination of factors, it demands action.

The Quest for Site Quality and Sustainability White Paper

There are a plethora of industry initiatives focused on enhancing the quality of clinical trials. And much of the focus is on defining site quality and performance metrics from the industry perspective. In this quest for site quality and sustainability,  SCRS recognized that a key perspective was missing: that of investigative sites. How do the sites view their current levels of quality? How do they feel they can and should be measured? What do they need to do internally to improve their performance and what do they need from their sponsor and CRO partners to enhance their quality as well as sustainability?

Responsible Site Management White Paper

These Best Site Practices are meant to provide clarity and guidance to sites to promote the achievement of a compliant, efficient and sustainable research site, and to be recognized as a site of commitment and quality by the research enterprise. It covers qualifications for Principal Investigators and site staff, how to gauge site performance and set up site infrastructure, remaining compliant with regulatory agencies, and more.

An Industry in Crisis White Paper

This paper examines the acute challenges faced by investigators and clinical research sites within the life sciences enterprise. As the sustainability of many sites has become increasingly tenuous, established sites and investigators struggle to remain viable. Others enter the industry with little chance to succeed, often quickly departing after conducting only one study, or no studies at all. There are enormous societal costs associated with this crisis, including financial costs to industry – and most importantly – the human cost of productive lives lost. SCRS shares emerging solutions that will better integrate clinical sites and investigators as full and sustainable partners within the clinical research ecosystem.

Better Payment Terms for Sites White Paper

A new medical therapy has just been approved and the sponsor touts this major achievement by publicizing the clinical trial results and the number of subjects who participated in the pivotal studies. Whether that number is 300 or 3,000, those subjects had to be recruited, enrolled, randomized, and engaged in a series of protocol-related visits to investigative sites, the very backbone of the clinical trials industry. Without sites, it would be virtually impossible to conduct clinical research. And whether those sites are free standing, linked to a medical practice or part of an academic medical center, they are a precious resource. Yet many are struggling, not only with ever more complex protocols, but also with the financial realities of operating a clinical research site.

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Whitepapers

Does Your eCOA Reduce Clinical Trial Risk?

YPrime announces a new report unveiling the top challenges that clinical trial executives face when implementing eCOA, and what to look for when evaluating new solutions.

2024 Annual Life Sciences Financial Planning & Accounting Report

2023 Clinical Trials Accounting & Reporting Benchmark Survey

Digital Biomarkers Solution shows pathway to reduced clinical trial sample sizes, shorter durations

Digital biomarkers provide a pathway to the future where clinical trial sponsors can potentially benefit from reduced trial duration and sample size. Learn more about these benefits from a simulated study.

Digital biomarkers show early clinical validity and provide greater confidence in Movement Disorder clinical trials

Digital biomarkers, smartphones, and wearables are transforming clinical trials by revolutionizing remote data collection and providing insights into treatment efficacy. Learn more about these exploratory endpoints and how they provide greater confidence in a clinical trial.

Five Key Benefits of Digital Biomarkers

Explore the five key advantages that underscore the significance of digital measurements in the context of clinical trials

2023 Clinical Research Industry Salary & Employee Satisfaction Survey Report

Transforming Prospective Study Data Acquisition & Delivery

Learn how your team can use EHR-to-EDC technology to reduce data monitoring costs, speed up data cleaning timelines, and hit study milestones faster.

Evaluating EDC Systems in a Modern DM Landscape

EDC Evaluation Guide

Looking for an EDC solution but overwhelmed by the process? This free guide highlights five steps to help you navigate the EDC vendor landscape and choose the right system for your study.

EHR-to-EDC Technology: A Guide to Modern Data Acquisition in Oncology Clinical Trials

Inside this eBook, readers can expect to learn how to effectively navigate the various challenges associated with clinical trial data collection and reporting in the age of digitalization and at a time in which site staff are experiencing turnover and seeking more efficiency.

How to Operationalize Infectious Disease Trials with a Virtual Site

In this playbook, learn how a virtual site solution expands access to infectious disease clinical trials by allowing patients to enroll and participate from anywhere.

Unlocking Oncology Insights - Innovations in Evidence Generation With RWE Solutions

The rapid evolvement of precision oncology requires real-world data generated at a scale that unlocks insights that can not be provided from clinical trial evidence. Machine learning and large language models can be used to quickly identify information, supporting custom integrated real-world evidence solutions to make informed decisions.

The Importance of NGS Panel Customization

Explore the pivotal role of Next-Generation Sequencing (NGS) panel customization in driving advancements in oncology research.

Incorporating the Patient Voice for Inclusive Medical Communications

By employing effective use of the patient voice, companies can better boost patient engagement success.

Guide to Incorporating Modern Research Tools and Techniques

This piece offers a practical assessment of leveraging various decentralized methodologies and technologies.

How to Start Your Real-World Evidence Journey

Delve into the impact of external stakeholder requirements in developing an integrated evidence generation strategy that maximizes product value.

Modern Approaches and Considerations for Designing Real-World Studies

Learn how strategic planning and patient-centric design of real-world studies drive value critical to stakeholder acceptance.

Going the Distance: Insights into Rare Disease Clinical Studies, Trial Retention & Patient Experience

Rare disease clinical research is complex. By shifting perspective and focusing on the patient experience throughout clinical trials, trial sponsors can learn about the unique barriers faced by patients and their loved ones, improve participation rates, and optimize the impact and outcomes of such studies.

Case Study: Successful System Integration for Decentralized Clinical Trials endpoint Clinical and THREAD’s Solution Ensures the Successful Flow of eConsent Data

Today’s clinical studies are increasingly complex and require patient-centric trial designs, like decentralized trials, more than ever before. As trials incorporate more decentralized components there is an ever-present need for multiple system integrations to support the various trial functions, with the goal being that all trial data flows seamlessly between systems and is stored in one repository for efficient oversight and analysis. These numerous integrated systems require closely managed integration, synchronization, and supportive partnerships to minimize error and maximize efficiency. In this case study, partners endpoint and THREAD dig-in to explore how IRT can be integrated with decentralized clinical trial (DCT) technology, working through tightly integrated workflows, to provide a streamlined process, a better user experience for Sites and Participants, higher quality data and real-time access to information.

How Can Phase I Data from the West Accelerate Drug Development in China and Japan? The Science and Practice of Ethnobridging

There is great value in global, multi-ethnic approaches to early-phase drug development, and they can accelerate the availability of new therapies in Asia.

New FDA Draft Guidance Shows That the Time for Decentralized Clinical Trials is Now.

On May 1, 2023, the U.S. Food and Drug Administration (FDA) released an updated Draft Guidance on decentralized trials. This release shows that the landscape of clinical research is rapidly evolving. The shift towards decentralized clinical trials presents an exciting opportunity for sponsors to improve patient engagement, enhance data quality, and accelerate clinical research. Are you prepared for what’s to come? Download the insight brief to learn more.

Addressing Challenges With Intelligent Point-of-Care Device Deployment

Key challenges and strategies to consider when developing devices intended for home-use or deployment in a clinical research setting.

Strategies to Fill Gaps in Patient Recruitment and Enrollment eBook

The patient recruitment and enrollment funnel is an overlooked pain point in clinical research. OneStudyTeam addresses inefficiencies in this stage, along with opportunities and strategies for improvement.

Strategies to Optimize Clinical Trial Enrollment Timelines eBook

Eliminate patient enrollment as a bottleneck for clinical trials. Start by using these strategies to optimize clinical trial enrollment timelines.

Clinical Data Trends, Challenges, and Opportunities

The Clinical Development Digitization Guide

Establishing a Foundation for a Holistic RBQM Strategy

Top 5 Data Pitfalls to Avoid in Oncology Trials

Top 5 Data Visualizations

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Comprehensive Summary of Site Engagement Literature

(spring 2024).

Much has been written in the literature — both peer- reviewed and trade journals — about the unprecedented operating challenges that the global community of investigative sites face. This reference resource provides a comprehensive summary with citations and links to these articles, organized by challenge category. In all, this resource offers valuable insights informing site engagement strategies and practices.

Access a copy of this White Paper Report 

Assessing Sponsor, Site, and Patient Receptivity to Retail Pharmacy Involvement in Clinical Trials

Benchmarking and Optimizing the Process for Adopting Innovations Supporting Clinical Trial Execution

(fall 2022).

Although there are conceptual frameworks and an extensive body of work in the literature examining the barriers and challenges associated with the adoption of new innovations supporting clinical trial execution, there is no empirical data benchmarking the process. As part of a working group study, Tufts CSDD conducted 26 in-depth interviews followed by an online survey that yielded 631 responses from the global community of drug development professionals. This study found that the four stages of the innovation adoption process – Initiation, Evaluation, Adoption Decision, and Full Implementation — takes 5.8 years on average with mid-sized companies taking one year longer than large companies and nearly two years longer than small companies. CROs are able to complete the innovation adoption process in half the time. High variation around the mean duration was observed overall and by company size showing highly inconsistent experience and the difficulty that companies face in navigating the process. The latter two stages of the process — Adoption Decision and Full Implementation — take the longest, are the most variable, and are regarded as the most difficult. Factors and approaches to accelerate the process and optimize innovation adoption are discussed.

Summary of themes from the

2021 executive roundtable examining, experiences implementing and , accommodating the ich e6 (r2) guidance, (june 2021).

On May 2021, the Tufts Center for the Study of Drug Development — in collaboration with, and with funding from, CluePoints and PwC — hosted a virtual roundtable comprised of R&D senior executives from pharmaceutical and biotechnology companies, contract research organizations (CROs) and a representative from the Food and Drug Administration. In total, 60 people participated in a virtual, facilitated discussion.

Drug Development Workforce in the Age of Digital Transformation

(june 2020).

Assessing the Financial Impact of Translational Pharmaceutics - A Platform for Accelerating Product Development

(october 2019).

ALPHA Project Unites Global Lupus Community on Barriers to Research, Drug Development, Care, and Access

(august 2019).

Summary Report From the Spring 2019 Executive Roundtable on Company Response to ICH E6 (R2)

(july 2019).

Manufacturing Strategy for Diverse Biologic Pipelines of the Future

(october 2017).

Assessing the Economics of Single-Source vs. Multi-Vendor  Manufacturing

Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development

Public and Private Sector Contributions to the Research & Development of the Most Transformational Drugs of the Last 25 Years  

(january 2015).

Industry Usage of Social and Digital Media Communities in Clinical Research

(june 2014).

A New Tool for Predicting Marketing Approval of Oncology Drugs

(december 2013).

The Adoption and Impact of Adaptive Trial Designs

Academic-Industry Partnerships for Biopharmaceutical Research & Development: Advancing Medical Science in the U.S.

(april 2012).

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White Paper

Car t manufacturing and toxicity.

Find out what FDA guidance says about integrating gene delivery vectors, such as CAR T cells, and gene editing technologies (like CRISPR).

sIRB Review for Multicenter Research: A Guide for Institutions

February 15, 2024

Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...

Operationalizing Research Analytics: Today, Tomorrow, Someday

Uncover how analytics, artificial intelligence, and machine learning are reshaping the foundational elements of clinical research.

GxP Compliance in Clinical Research

This white paper walks through key GxP principles and regulatory requirements and gives a real-world case study.

4 Modernized Functions Every Sponsor Needs for Study Startup

This white paper outlines four technology capabilities sponsors need to expedite the study startup process.

Navigating Key Complexities in the Development of Cell and Gene Therapies

Explore the uniquely complex regulatory guidelines and challenges cell and gene therapy presents in research.

Data on the go: Mobile Application Considerations for Clinical Trials and Beyond

Find out the necessary regulatory and ethical considerations when utilizing an app or connected device in human subjects research.

Unique First-in-Human Phase I IRB Considerations you Might not Know About

An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.

Understanding how to Build and Leverage a DSMB Statistical Plan

Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.

Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success

Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.

What Does an Endpoint Adjudication Committee (EAC) Do?

This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.

Establishing and Operating a DSMB: Tips for Clinical Trial Success

This white paper shares what a data safety monitoring board's (DSMB's) role is in clinical research and how it works.

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Decentralized Clinical Trials: Perspectives for Clinical Research Professionals

This new white paper, published in march 2022, assesses the significant implications of how decentralized clinical trials (dcts) leverage digital technologies to interact remotely with trial participants..

Vastly increased DCT usage in the past two years has enabled clinical research to advance during the COVID-19 pandemic as part of a trend that is forecast to continue.

Authored by members of ACRP’s Fellows Advisory Panel , the paper notes that potential benefits of DCT’s include a reduced need for sponsor and study site resources, and a better, more convenient study subject experience with fewer, shorter clinic visits and less frequent face-to-face contact.

Concerns related to DCT elements include the potential for missed opportunities to detect safety signals, increased data errors, and greater reliance on study subject compliance.

Key recommendations of the paper include:

• Sponsors, contract research organizations, vendors, and sites should review and potentially customize each study plan to account for decentralized elements.
• Clinical investigators should consider adapting site infrastructures to conduct studies that will likely require fewer patient site visits and increased remote data collection locations.
• Sponsors and CROs should consider modifying standard operating procedures and study-specific plans to train study subjects, provide access to study coordinators or coaches, and enable electronic communications.
• Clinical teams may need to expand to support digital communication and data collection, including electrical engineers, computer scientists, data engineers, or informatics specialists.
• Financial aspects of clinical research may need to be modified to reflect new activities, responsibilities, and data collection locations.
• Training curricula offered by ACRP (and other educational organizations) for clinical research professionals need to adapt to a wider range of new clinical operation models and roles.

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Ebooks & white papers.

Insights on clinical research written by CRIO

The Rise of the Clinical Trial Site Mega Network

Discover our latest eBook, “The Rise of the Clinical Trial Site Mega Network” the third installment in our “Scaling and Innovating” series. The first book in this series was published in 2019, where CRIO predicted that clinical research site networks would continue to grow and consolidate the industry. The second eBook, which was published in...

Health Information & Clinical Research Integration: The Challenge

In the past several decades, Electronic Health Record (EHR) systems have become the standard in documenting clinical care in the United States and many other countries, while Electronic Data Capture (EDC) systems have become standard in global pharmaceutical trials. Naturally, the industry has been highly focused on the tantalizing possibility of integrating EHR into EDC....

A Comparison of EMR and eSource Data

In a comparison of EMR and eSource data, we analyzed the medications and medical history documented in the EMR versus the EDC of subjects in active ongoing clinical research studies. The goal was to assess the validity of the assumption of the utility of using EMR data directly. The present study reveals a significant data...

An Enterprise-Grade eClinical Solution – CRIO

You need a partner that is capable of meeting your enterprise requirements and regulatory obligations. CRIO is an enterprise-grade eClinical solution. This guide describes some of CRIO’s best practices that differentiate us from other vendors. Download the full white paper to explore CRIO, the industry’s #1 site-based eSource solution.

eSource Reduces Protocol Deviations Compared to Paper Source

With nine locations in Texas, California and Louisiana, and five-time recipient of the Best Clinical Trials Site/Network award from the World Vaccine Congress, Benchmark Research is one of the industry’s leading vaccine network. This white paper provides an in-depth analysis from three participating Benchmark Research. Specifically, results indicate that using CRIO electronic source (eSource) reduces...

Today’s Broken EDC Model vs The CRIO Model

This primer describes CRIO’s integrated eSource-EDC model. In this model, data are captured once by the site, against electronic source templates built by the sponsors. Next, the data are surfaced in a sponsor-facing application called Reviewer EDC. Using Reviewer EDC, sponsors can review, query, lock, code, and extract the data. Download the full case study...

What’s Driving Site Network Consolidation? The Reinvention of Site Networks, Part 2

In a 2019 CRIO eBook, “Scaling and Innovating: The Consolidation and Reinvention of Clinical Research Sites,” we explored the emerging trend of clinical research site consolidation. Today, there are five times as many site networks today as in 2015. Sponsors are taking notice and driving a lot of this shift. What does this mean for...

SOP Templates for Clinical Research Sites During Coronavirus

A pack of 5 detailed SOP templates for your clinical trial site during the Coronavirus (COVID-19) Outbreak.

Staffing Shortages in Clinical Research Highlight Opportunities for Sponsors to Provide Support

Identifying ways to increase efficiency in the clinical research workforce. Staffing shortages at clinical research sites are having a major impact on clinical trials worldwide. Exacerbated by the COVID-19 pandemic, these workforce constraints have forced research professionals to accomplish more with fewer resources. CRIO and TPS surveyed members of the Association of Clinical Research Professionals...

A Survey of Clinical Research Site Operations Post COVID

This CRIO white paper, A Survey of Clinical Research Site Operations Post COVID, includes the complete results from CRIO’s latest web survey on post-COVID operations at clinical research sites.

Choosing the Right eSource Solution: A Comprehensive Checklist for Sites and Site Networks

Choosing the right eSource solution is a critical decision for clinical research sites because it can significantly impact operational efficiency, data quality, and compliance. With numerous options available, selecting the right eSource system can be a daunting task. To simplify the process, it is important to consider several key factors. We’ve compiled a comprehensive checklist...

CRA Survey Results Summary

The clinical research industry made big changes to adapt to the operational disruptions of a global pandemic. Today, it’s more exciting and diverse than ever before. With the high level of recent technology adoption, CRIO wanted to learn more about CRA  experiences using the CRIO platform. Method Between March 16 and March 30, 2022, a...

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• Published: 14 October 2021

Improving diversity in medical research

• Ashwarya Sharma   ORCID: orcid.org/0000-0002-8653-1325 1 &
• Latha Palaniappan 1  

Nature Reviews Disease Primers volume  7 , Article number:  74 ( 2021 ) Cite this article

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• Adaptive clinical trial
• Health policy

Clinical research is essential for the advancement of medicine; however, trials often enrol homogeneous populations that do not accurately represent the patient populations served. Representative and diverse research participation is necessary to establish fair standards of care, minimize outcome disparities between populations, and achieve and uphold social equity.

Since the early 2000s, clinical research has become more global and complex, as the number of clinical trials conducted to create interventions that improve patients’ health is increasing worldwide. Interest in the community is growing to recognize unique characteristics of clinical trial participants, in an attempt to better understand variability in drug responses. However, the diversity of patient populations remains under-represented in clinical trials, despite being a vital component in enabling medical research to move towards precision medicine approaches.

Severe imbalance in the representation of minorities is not new; clinical research has long been criticized for enrolling homogeneous populations that do not accurately represent the communities served.

In a 2020 analysis of the global participation in clinical trials, the FDA highlighted the vast difference between the enrolled participants and the global population. Of 292,537 participants in clinical trials globally, 76% were white, 11% were Asian and only 7% were Black 1 . In comparison, the global population (~7.8 billion) is distributed with ~60% of the population in Asia, ~16% in Africa, ~10% in Europe and ~8% in Latin America ( World Population Review ). Similarly, a review of 379 clinical trials funded by the US National Institute of Mental Health published in 1995–2004 found that all racial or ethnic groups except white individuals and African Americans were under-represented, and only ~48% of the studies provided complete racial or ethnic information 2 . Thus, data for global populations are lacking, and current guidelines and clinical decisions are based on insufficiently diverse trials and studies.

Past thinking has favoured the enrolment of individuals with similar characteristics to limit heterogeneity and to decrease the effects of interindividual variability and achieve consistent short-term results. In the future, we must strive to represent all populations that will eventually use the tested drugs and devices. Although enrolling diverse populations may initially bring higher variability in results than enrolling homogeneous populations, the outcome data can be leveraged through statistical analysis and novel study designs to tailor and individualize therapies, which can ultimately result in improved generalizability for the populations we serve.

In the future, we must strive to represent all populations that will eventually use the tested drugs and devices

Development of interventions that are not tested in diverse populations can lead to treatments that are less effective and less trusted in some populations, despite their need for the intervention. For instance, 5-fluorouracil, a well-studied, commonly used chemotherapeutic drug, was found to lead to adverse effects, including haematological toxicities, in certain individuals. These toxic effects occurred at higher rates in African American individuals than in white individuals 3 . However, this observation was not revealed in preceding clinical trials, as these had limited patient diversity, which ultimately negatively affected African American individuals’ health care 4 . Similarly, Ninlaro (ixazomib), approved by the FDA in 2015 for the treatment of multiple myeloma, had only 1.8% Black participants in the phase III clinical trial despite African Americans having higher incidence and prevalence of this disease than European Americans 5 , 6 . Under-represented populations are deeply affected by these inequities, as they can lead to distrust and worse health outcomes for certain populations compared with others.

This failure for meaningful diversity in health research also has considerable social and ethical implications, as individuals and entire subgroups that are traditionally under-studied may be unable to access potentially beneficial research. Overall, the imbalance leads to substantial differences in their lifelong care, leading to additional health inequities. Notably, the COVID-19 pandemic has further exposed these great inequalities in health, as Black, Latinx, Pacific Islander and other vulnerable populations have been disproportionately affected by SARS-CoV-2. A 2020 study showed that 34% of overall deaths were among non-Latinx Black people, although this group only accounts for 13% of the overall US population 7 . This increased disease mortality in these populations is thought to be due to pre-existing comorbidities, such as hypertension or diabetes, decreased access to testing, inequities in health-care delivery, exposure risks and, potentially, genetic differences. However, the relative risk of any of these underlying factors is unknown, as data addressing these issues are lacking.

Development of interventions that are not tested in diverse populations can lead to treatments that are less effective and less trusted

Historically, five major challenges have been highlighted for reduced participation in clinical trials — low income; investigator bias; mistrust in medical research and professionals; limited health and research literacy; and lack of access to transportation 8 . In particular, investigator bias and medical mistrust are uniquely present in medical practice. Investigator bias or the implicit biases that health-care providers may have can interfere with enrolment in clinical studies and are associated with poor quality of care. Taken together, patients of racial or ethnic minority have been found to receive poorer care than white patients across numerous illnesses, in part owing to biases and a lack of research on how specific diseases may uniquely affect various populations 8 . For instance, studies have shown that Asian American individuals are more likely to develop diabetes mellitus at lower body weight than white Americans 9 . However, limited resources of health information and research dedicated specifically to Asian American audiences are available. Mistrust and skepticism of medical professionals and the health-care system by minority and other under-represented groups exist owing to historical abuses, such as the US Public Health Service (USPHS) Syphilis Study at Tuskegee and forced sterilization of American Indians. As a consequence, the affected communities have less participation in trials and, in some cases, poorer health outcomes 10 .

To overcome the long-standing inequalities in health care and patient outcomes, the research community must commit to diversity and inclusion in clinical research. Here, we provide a framework for increasing diversity in clinical trials using the socioecological model (Fig.  1 ). Changes to public policy, community, institutional, interpersonal and intrapersonal domains can be used to increase diversity in research. At the public policy level, we can set strict requirements for representation of diverse populations as a necessity for approval of new drugs and devices. Uniform standards across research are needed to collect and record variables that capture various aspects of diversity, such as race or ethnicity, ancestry, language, religious practices and sexual orientation. At the community level, researchers must consider the specific priorities of patients and communities affected by the condition to ensure that the intended populations can be effectively recruited. At the institutional level, we must develop knowledge resources specifically for communities with historical medical mistrust. Institutions can transparently provide data for drug efficacy across different populations and acknowledge and address areas in which data do not currently exist. At the interpersonal level, we need to increase representation across training pathways to ensure diversity in all research and development teams. Further work is needed to understand knowledge, beliefs and attitudes towards clinical research at the intrapersonal level and known barriers to involvement in research should be addressed with the required support measures.

Changes to public policy, community, institutional, interpersonal and intrapersonal domains can result in increased diversity in research and help overcome inequalities in health care and patient outcomes.

The imbalance of representation of diverse groups in clinical research is a problem that continues to adversely affect health care for all and is one that medical professionals must be prepared to address.

U.S. Food & Drug Administration. 2015–2019 drug trials snapshots summary report. FDA https://www.fda.gov/media/143592/download (2020).

Mak, W. W. S. et al. Gender and ethnic diversity in NIMH-funded clinical trials: review of a decade of published research. Adm. Policy Ment. Health 34 , 497–503 (2007).

Article   Google Scholar  

McCollum, A. D. et al. Outcomes and toxicity in African-American and caucasian patients in a randomized adjuvant chemotherapy trial for colon cancer. J. Natl Cancer Inst. 94 , 1160–1167 (2002).

Article   CAS   Google Scholar  

Meta-Analysis Group In Cancer et al. Toxicity of fluorouracil in patients with advanced colorectal cancer: effect of administration schedule and prognostic factors. J. Clin. Oncol. 16 , 3537–3541 (1998).

U.S. Food & Drug Administration. Drug trials snapshots: ninlaro. FDA https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ninlaro (2016).

Landgren, O. et al. Risk of monoclonal gammopathy of undetermined significance (MGUS) and subsequent multiple myeloma among African American and white veterans in the United States. Blood 107 , 904–906 (2006).

Holmes, L. Jr. et al. Black–white risk differentials in COVID-19 (SARS-COV2) transmission, mortality and case fatality in the United States: translational epidemiologic perspective and challenges. Int. J. Environ. Res. Public Health 17 , 4322 (2020).

Bierer, B. E. et al. Achieving diversity, inclusion, and equity in clinical research guidance document version 1.2. The MRCT Center of Brigham and Women’s Hospital and Harvard https://mrctcenter.org/diversity-in-clinical-research/download/2326/ (2021).

Hsu, W. C. et al. BMI cut points to identify at-risk Asian Americans for type 2 diabetes screening. Diabetes Care 38 , 150–158 (2015).

George, S., Duran, N. & Norris, K. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. Am. J. Public Health 104 , e16–e31 (2014).

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Sharma, A., Palaniappan, L. Improving diversity in medical research. Nat Rev Dis Primers 7 , 74 (2021). https://doi.org/10.1038/s41572-021-00316-8

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Diversity in Clinical Trials: Life Sciences Initiatives and Challenges in Light of the FDA’s Latest Guidance

Home / intelligence / white papers / diversity in clinical trials: life sciences initiatives and challenges in light of the fda’s latest guidance.

To date, life sciences’ efforts towards driving equitable healthcare have centered around access to care, early identification and prevention. Meanwhile, less attention has been given to the impact of the racial and ethnic homogeneity in trial populations. Clinical trial diversity continues to be one of the greatest challenges pharmaceutical and biotech companies face in ensuring the delivery of medicines that are effective for all people. Diverse clinical trial populations are an integral step in achieving equitable healthcare treatment.

While we understand “diversity” to be more broadly inclusive of women, disabled persons, rural populations and racial minorities, when assessing the diversity of clinical trials, the FDA focuses mostly on racial and ethnic minorities, which will be the focus of this white paper.

While efforts to improve racial and ethnic diversity in trials have increased in the last decade, disparities still remain. Although over 40% of the United States (U.S.) population is currently comprised of ethnic and racial minorities, often only 5 to 10% of clinical trial participants represent any minority population. This disparity is striking and exposes the non-white population to harm as a result of an uncomfortable gap of knowledge around what is effective and ineffective (or even dangerous) in minority patients.

In 2022 the U.S. Food and Drug Administration (FDA) released draft guidance for the pharmaceutical industry outlining tactics and plans to improve clinical trial participation from underrepresented racial and ethnic populations within the U.S. Clinical trial diversity is not a new topic for pharmaceutical companies who have implemented strategies to address it throughout the past decade. However, as the FDA’s focus has shifted to this topic, with clearer guidelines coming into view, there has been a significant uptick in pharmaceutical engagement on the topic.

This paper is a follow up to Diversity in Clinical Trials Participation: A Life Sciences Perspective focused on understanding what is being done to recruit and retain diverse trial populations from the perspective of African American/Black and Hispanic/Latinx former clinical trial participants, clinical trial coordinators and principal investigators (physicians). From that research, we learned where the gaps are and provided some prescriptive guidance on what initiatives would help increase the number of diverse trial participants.

For this paper, our research sought to understand what initiatives are being undertaken at the corporate level to improve the diversity of trials, the effectiveness of those initiatives and the impact of the FDA’s guidance to improve diversity now and in the future.

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Time-domain methods for quantifying dynamic cerebral blood flow autoregulation: Review and recommendations. A white paper from the Cerebrovascular Research Network (CARNet)

Affiliations.

• 1 Department of Electrical and Computer Engineering, McGill University, Montreal, QC, Canada.
• 2 Institute of Neural Engineering, Graz University of Technology, Graz, Austria.
• 3 Departamento de Ingeniería Informática, Universidad de Santiago de Chile, Santiago, Chile.
• 4 Department of Kinesiology, Faculty of Medicine, Université Laval, Quebec, QC, Canada.
• 5 Research Center of the Institut universitaire de cardiologie et de pneumologie de Québec, Quebec, QC, Canada.
• 6 Department of Geriatrics, Radboud University Medical Center, Research Institute for Medical Innovation and Donders Institute, Nijmegen, The Netherlands.
• 7 Cerebral Haemodynamics in Ageing and Stroke Medicine (CHiASM), Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
• 8 Department of Clinical Neurosciences, Neurosurgery Department, University of Cambridge, Cambridge, UK.
• 9 Department of Neurology and Clinical Neurophysiology, University Medical Center Groningen, Groningen, The Netherlands.
• 10 Medical Biodynamics Program, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
• 11 Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.
• 12 Laboratory for Engineering and Scientific Computing, Institute of Advanced Computing and Digital Engineering, Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China.
• 13 Department Biomedical Engineering, Viterbi School of Engineering, University of Southern California, Los Angeles, CA, USA.
• 14 Institute of Applied Mechanics, National Taiwan University, Taipei, Taiwan.
• 15 Institute of Sound and Vibration Research, University of Southampton, Southampton, UK.
• 16 Cerebrovascular Concussion Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
• 17 Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
• 18 Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.
• 19 NIHR Leicester Biomedical Research Centre, British Heart Foundation, Glenfield Hospital, Leicester, UK.
• 20 Department of Bioengineering, McGill University, Montreal, QC, Canada.
• PMID: 38688529
• DOI: 10.1177/0271678X241249276

Cerebral Autoregulation (CA) is an important physiological mechanism stabilizing cerebral blood flow (CBF) in response to changes in cerebral perfusion pressure (CPP). By maintaining an adequate, relatively constant supply of blood flow, CA plays a critical role in brain function. Quantifying CA under different physiological and pathological states is crucial for understanding its implications. This knowledge may serve as a foundation for informed clinical decision-making, particularly in cases where CA may become impaired. The quantification of CA functionality typically involves constructing models that capture the relationship between CPP (or arterial blood pressure) and experimental measures of CBF. Besides describing normal CA function, these models provide a means to detect possible deviations from the latter. In this context, a recent white paper from the Cerebrovascular Research Network focused on Transfer Function Analysis (TFA), which obtains frequency domain estimates of dynamic CA. In the present paper, we consider the use of time-domain techniques as an alternative approach. Due to their increased flexibility, time-domain methods enable the mitigation of measurement/physiological noise and the incorporation of nonlinearities and time variations in CA dynamics. Here, we provide practical recommendations and guidelines to support researchers and clinicians in effectively utilizing these techniques to study CA.

Keywords: CARNet; cerebral autoregulation; cerebral blood flow; time-domain methods; white paper.

Publication types

The Evolution of Black-White Differences in Occupational Mobility Across Post-Civil War America

This paper studies long-run differences in intergenerational occupational mobility between Black and White Americans. Combining data from linked historical censuses and contemporary large-scale surveys, we provide a comprehensive set of mobility measures based on Markov chains that trace the short- and long-run dynamics of occupational differences. Our findings highlight the unique importance of changes in mobility experienced by the 1940–1950 birth cohort in shaping the current occupational distribution and reducing the racial occupational gap. We further explore the properties of continuing occupational inequalities and argue that these disparities are better understood by a lack of exchange mobility rather than structural mobility. Thus, contemporary occupational disparities cannot be expected to disappear based on the occupational dynamics seen historically.

We thank participants at the Conference on Inequality and Mobility 2023 and SSHA 2023 for their comments and feedback. This paper has greatly benefited from discussions with Kristina Butaeva, Yoosoon Chang, Jonas Helgertz, Aleksandra Lukina, Joon Park, and Zachary Ward. We thank Ken Suzuki and Jiaowei Gong for their excellent research assistance. Gueyon Kim is grateful for the financial support of the Hellman Fellowship and the UC Santa Cruz COR grant. All authors acknowledge generous support of the Stone Center for Research on Wealth Inequality and Mobility at the University of Chicago. Dohyeon Lee’s contribution was prior to joining Amazon and does not represent Amazon’s views. James M. and Cathleen D. Stone Foundation are the funders of the Stone Center for Wealth Inequality and Mobility at the University of Chicago, which is the primary source of support for this project. Gueyon Kim also acknowledges financial support of the Hellman Fellowship. The views expressed herein are those of the authors and do not necessarily reflect the views of the National Bureau of Economic Research.

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Hope Hicks gets teary testifying at Trump’s hush money trial

After a week of tabloid-focused testimony, the former aide led the jury through the whirlwind of the 2016 campaign and directly to the Oval Office.

NEW YORK — Hope Hicks, a former top aide to Donald Trump , appeared to break down crying on the witness stand Friday at Trump’s criminal trial, where she described campaign and White House efforts to keep a lid on scandalous stories about his past sex life.

Her time on the stand marked a significant shift in the focus of trial testimony; after days of hearing about tabloid editors and secret deals to stifle or sell celebrity gossip, the jury was led through the whirlwind of the 2016 presidential campaign and directly to the Oval Office.

Prosecutors with the Manhattan district attorney’s office wanted Hicks to show the jury how worried the 2016 Trump campaign was about negative stories about him and women — a key element in Trump’s alleged motive in the hush money case.

Her testimony seemed to accomplish that limited goal, but overall her tenor was respectful and complimentary of Trump, the presumptive GOP nominee for president in the November election; far from an aide turning against her former boss, she came across as a still-loyal and reluctant participant in his prosecution.

Hicks has long been seen as one of Trump’s most loyal aides, following him from his business to the 2016 presidential campaign to the White House. After about two hours on the witness stand in a packed courtroom, she was overcome by emotion as Trump lawyer Emil Bove prepared to cross-examine her.

As Bove began, Hicks slowly turned her face away from Trump, who was sitting at the defense table, and toward the jury. She brought her hand to her nose and started to quietly cry.

“Miss Hicks, do you need a break?” asked New York Supreme Court Justice Juan Merchan .

“Yes,” she said through tears.

Trump hush money trial

With that, the jury was sent out of the courtroom while Hicks collected herself.

Trump had watched Hicks enter the courtroom but did not react much during her time on the stand; at some points he wrote notes and passed them to his lawyers, but mostly he sat impassively at the defense table, listening with his eyes mostly closed.

Hicks appeared nervous at the start of her testimony, but there was no confrontation or revelation that seemed to prompt her emotional moment. It appeared that the attention of the high-profile trial, and being a prosecution witness against her former boss, whom she described in positive terms, became overwhelming as the day wore on.

Hicks told the jury about conversations inside the White House in 2018, as aides dealt with the fallout from news stories about payments made to two women during the 2016 campaign to keep them from going public with allegations about sexual trysts with Trump.

Under questioning from prosecutor Matthew Colangelo, Hicks recounted speaking to Trump after an article appeared in 2018 about a payment to adult-film actress Stormy Daniels. That $130,000 payment was first made by Michael Cohen, then a lawyer for Trump, whom Trump later reimbursed. Those reimbursements, and their categorization as legal costs rather than campaign expenses, are the basis of the 34-count indictment filed against Trump by Manhattan District Attorney Alvin Bragg (D).

After that hush money payment was detailed by the Wall Street Journal, Hicks said, Trump told her that “Michael had paid this woman to protect him from a false allegation, and that Michael felt like it was his job to protect him and that’s what he was doing and he did it out of the kindness of his heart.” Soon after the story came out, Cohen publicly claimed to have made the payment with his own money.

Cohen completed a three-year prison term after pleading guilty to fraud and lying, and has become an outspoken Trump critic . He is expected to be a key witness in the case. Hicks on Friday became the latest of several trial witnesses who have said biting things about Cohen .

Asked if it sounded like Mr. Cohen to make a $130,000 payment “out of the kindness of his heart,” Hicks replied, “I’d say that would be out of character for Michael … I didn’t know Michael to be an especially charitable person or selfless person.”

She said he was “the kind of person who seeks credit.”

At another point, Hicks wryly mentioned that Cohen liked to refer to himself as a “fixer,” yet in her experience, he fixed things “only because he first broke it.”

For prosecutors, the main purpose of Hicks’s testimony seemed to be showing that Trump and his campaign were very concerned about allegations made against him by women.

When it came to the Daniels story, which surfaced publicly while he was in the White House, Hicks said Trump told her that “it was better to be dealing with it now, and it would have been bad to have that story come out before the election.”

As soon as Hicks said that, prosecutors ended their questioning.

Her testimony, while emotional at one moment, did not offer any major revelations or surprises, but it adds to prosecutors’ larger point that Trump was motivated to keep scandalous stories out of the public eye during the election.

But Hicks’s account also made clear that her former boss was concerned about the potential effect of the allegations on his family.

When the Journal published a story in early November 2016 about the National Enquirer buying the rights to a Playboy model’s tale of an affair with Trump — a purchase the tabloid made for the express purpose of keeping the allegation quiet — Hicks said the presidential candidate worried about Melania Trump’s reaction.

In her role as a campaign adviser, Hicks said, she wanted to “blow past it and keep going,” since the election was only days away.

She said Trump was “concerned about the story, he was concerned about how it would be viewed by his wife, and he wanted me to make sure that the newspapers weren’t delivered to their residence that morning.”

By that point, the campaign had already been rocked a month earlier, when The Washington Post revealed the existence of an “Access Hollywood” recording in which Trump bragged about grabbing women’s genitalia.

That story unleashed a political maelstrom, Hicks testified. Prosecutors wanted her testimony in part to show that, after the scandal, Trump and his campaign were desperate to prevent further damaging stories about him and women, and that gave the candidate and his staff a powerful motive to keep Daniels and any other potential accusers quiet.

Hicks said she was “a little stunned” when she was first asked for comment about the “Access Hollywood” tape, and wrote in an email that they should “deny, deny, deny.”

“I had a good sense that this was going to be a massive story and sort of dominate the news cycle for the next several days at least,” she said. “This was a crisis.”

At times in her testimony, Hicks flashed a sense of humor, noting that around the same time as that story, a hurricane hit the East Coast.

“I don’t think anybody remembers where or when that hurricane made landfall,” she said. “It was all Trump, all the time, for the next 36 hours.”

The 11th day of the trial — the first time a former U.S. president has faced criminal charges — began with the judge reassuring Trump that despite being found in contempt of court for repeated violations of his gag order, Trump still had an absolute right to testify in his defense if he wanted to do so later.

“It came to my attention that there may be some misunderstanding regarding the order,” Merchan said, referring to comments Trump made a day earlier in the courthouse hallway. Speaking to reporters, the former president had complained that the judge’s order — which bars him from talking about witnesses, or the families of the judge or the prosecutor — prevented him from testifying. It does not.

Merchan tried to clear up the issue by telling Trump: “You have an absolute right to testify at trial if that’s what you decide to do after consultation with your attorneys.” The gag order, he said, only applies to statements made outside the courtroom, whether in the hallway, in media interviews or on social media.

As Merchan spoke, Trump nodded in agreement.

Trump has flirted publicly with the idea of testifying in his defense, though lawyers usually advise defendants not to do so, because it gives prosecutors a chance to question the person under oath in front of the jury.

Trump has been found in contempt of court for nine statements that violated the judge’s gag order, and Merchan is considering four additional statements that may also be violations.

Later Friday, a court official said Trump has paid the $9,000 in fines he owed for those violations. The payment was made in two installments: one for $2,000 and another for $7,000.

Trump New York hush money case

Former president Donald Trump’s criminal hush money trial is underway in New York. Follow live updates from the trial .

Jury selection: A full jury of 12 jurors and six alternates has been seated. Here’s what we know about the jurors .

The case: The investigation involves a $130,000 payment made to Stormy Daniels, an adult-film actress , during the 2016 presidential campaign. It’s one of many ongoing investigations involving Trump . Here are some of the key people in the case .

The charges: Trump is charged with 34 felony counts of falsifying business records. Falsifying business records is a felony in New York when there is an “intent to defraud” that includes an intent to “commit another crime or to aid or conceal” another crime. He has pleaded not guilty . Here’s what to know about the charges — and any potential sentence .

Can Trump still run for president? The short answer, legal experts said, is yes. The U.S. Constitution does not forbid Trump, or anyone else, from serving as president if convicted of a felony.

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• Hope Hicks witnessed nearly every Trump scandal. Now she must testify. May 3, 2024 Hope Hicks witnessed nearly every Trump scandal. Now she must testify. May 3, 2024