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Introduction to Clinical Research

Sep 26, 2014

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Introduction to Clinical Research. Clinical Research Practice 1. This Course Will Introduce You To:. The basics of clinical research, types of clinical trials and why clinical research is necessary.

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• clinical research
• informed consent
• research misconduct
• clinical research trials
• define good clinical practice

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Introduction to Clinical Research Clinical Research Practice 1

This Course Will Introduce You To: • The basics of clinical research, types of clinical trials and why clinical research is necessary. • Good Clinical Practice and Good Laboratory Practice that guide the conduct of clinical research. • The importance of protecting participants and the informed consent procedures. • The overall goals of the current trials. 2

Objectives: • Define clinical research and explain why we perform clinical research. • Define Standard Operating Procedure. • Identify the types of clinical research trials. • Define protocol. • State the protections given to human participants in clinical research. • Define Good Clinical Practice and Good Laboratory Practice. 3

Objectives: • Explain why GCP and training given by the PDP are important to you. • Identify staff that must comply to research ethics and standards. • Explain the importance of “amendments” to a protocol. • Define Case Report Forms and Source documents and their importance in a trial. • Define informed consent and list some of the rules of the process. • State the overall goals of the clinical trial you are working on. 4

What Is Clinical Research? • A scientific research study. • A clinical trial looking for answers to specific questions. • Method for finding safe, new and improved vaccines, drugs, and other treatments to improve health. • Research that relies on human volunteers. 5

So……Clinical Research Is… • Research performed on humans. • Designed to answer specific questions related to human disease, diagnosis, prevention, outcomes and treatments. 6

Why Do We PerformClinical Research? • Test new therapies and drugs. • Gather data from participants who have had a known intervention and monitor results. • Determine the safety and effectiveness of drugs, therapies, and other treatments. • Develop new drugs and treatments that are safer, more effective and faster working than any before. • Ultimately – to improve health status. 7

What Happens In a Clinical Trial? • Human participants are recruited for a particular study based on stated criteria as described in the protocol of the study. 8

Then……. • Participants are fully informed about the trial and give informed consent to participate in the clinical trial. 9

And Only Then…. • A team of doctors, nurses and other research professionals: • check the health of the participant at the beginning of the trial. • give specific instructions for participating in the trial. • monitor the participant carefully during the trial. • collect the relevant data • analyze the data and draw conclusions • report results and share conclusions 10

How Does The Team Ensure Uniformity In Research? Standard Operating Procedures Detailed, written instructions to achieveuniformity of the performance of a specific function. 11

Types of Clinical Research Trials • Treatment trials • Prevention trials • Diagnostic trials • Screening trials • Quality of life trials 12

Types of Clinical Research Trials Treatment trials:Test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. 13

Prevention trials:Look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. May include medicines, vitamins, vaccines, minerals, or lifestyle changes. 14

Diagnostic trials: Are conducted to find better tests or procedures for diagnosing a particular disease or condition. 15

Screening trials:Test better ways to detect a disease or particular health condition. 16

Quality of life trials: Explore ways to improve comfort and the quality of life for individuals with a chronic illness. 17

The Life Cycle Of A Clinical Research Project Write a ResearchProposal Define Research Question (What do you want to know?) Write Protocol Find Funding & Select Research Team Get RegulatoryApproval Conduct Research Analyse Results Report Results 18

Key Parts of the Process • Get Regulatory Approval:Regulatory bodies monitor and approve research. • Institutional Review Board or Ethics Committee (IRB/IEC) • Medicines Control Council (MCC) • South African National Accreditation System (SANAS) • Find Funding:A sponsor, pharmaceutical company, research institution, or other organization funds the project. • Protocol:The study plan. Written procedures detailing the steps to conduct a study, keep participants safe and ensure valid data. 19

Performing Research in South Africa Offers an Unique Environment Significant burden of disease. Hightechnologicalmedical expertise andinfrastructure. SouthAfrica Money, resources and other support for research. Racial-CulturalDiversity 20

Rapid Increase in Research • South Africa has seen a 40% growth in research since 1997. • Could lead to the potential for unscrupulous, unethical and unnecessary conduct of clinical research. RISK 21

Risk of Research MisconductGreatest When Dealing With… • Poor populations. • Low levels of literacy. • Unquestioning acceptance of authority. • Great need for health services. • No knowledge of research. 22

Research Is So “New” …Can You See Why We Need Guidelines? In the light of this growth and unique environments, the need to carefully regulate and guide the conduct of clinical trials becomes urgent and necessary. 23

HowDo We Protect Our Research Participants Against Research Misconduct? • Research principles and guidelines • Research regulations • Informed Consent 24

Principles to Protect Participants GCP GLP Good Clinical Practice Good Laboratory Practice 25

Good Clinical Practice GCP • An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human volunteers. • Simply put …. GCP is the rules by which we conduct our research. 26

Good Laboratory Practice GLP • Represents a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. • Simply put …. GLP is the rules of research in the lab. 27

History of GCP • Nazi Medical War Crimes Nuremberg Code- 1947 29

Declarationof Helsinki (DOH) 1964 Developed by the World Medical Association First significant effort of the medical community to regulate itself. 30

Tuskegee Syphilis Study 1932-1972 Belmont Report 1979 Cornerstone for ethical principles underlying the acceptable conduct of research using human volunteers. 31

Many regulations……needed one standard International Conference on HarmonizationApril 1990 Principles of ICH GCP 32

13 Principles of ICH GCP Two important principles are: • The rights, safety, and well-being of the trial participants are the most important considerations and should prevail over the interest of science and society. • Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). 33

History of GLP • Malpractice – 1970’s • Organization for Economic Co-operation and Development (OECD) 30 Countries-1981 OECD GLP Principles 35

OECD GLP Principles • Regulates the practices of scientists working on the safety testing of prospective drugs. • Imposed by regulatory authorities. • South African National Accreditation System (SANAS) 36

GLP: Fundamental Points • Resources • Rules • Characterization • Documentation • Quality Assurance Photo courtesy of Aeras Global TB Vaccine Foundation. 37

Why Is Following GCP and GLP Important ? Compliance with these standards assures: • participant rights are protected. • the safety of human volunteers. • participant well-being is a priority. • results are used for improvement of health and well-being of all. 38

Why Is Following GCP and GLP Important to You? As part of the research team, each and every one of us is responsible for following ethical guidelines and ensuring valid and credible results. 39

HowDo We Protect Our Research Participants Against Research Misconduct? • Research principles and guidelines • Research regulations • Informed Consent 40

How Is Research Regulated? InstitutionalReview Board or Ethics Committee Data Safety Monitoring Board Research Participant Medicines Control Council SANAS 41

……What If We Need To Change Something ? Remember the Protocol?...... Ask for a protocol amendment…… “A written description of a change(s) to or formal clarification of a protocol.” ( Definition from the ICH Guideline for Good Clinical Practice 1.45) 42

Data Collection Source Data • All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. (ICH 1.51) Source Documents • Original documents, data and records. (ICH 1.52) Case Report Form (CRF) • A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. (ICH 1.11) 43

A Few Rules for Completing Study Documentation: • Make sure that you are designated to complete the documents. • Write legibly. • Do not leave any blank fields on documents. • Do not use correctional fluid. • Double check that information is accurate and consistent with the source document. • Make corrections and edits according to GCP guidelines. (ICH 4.9) 44

HowDo We Protect Our Research Participants Against Research Misconduct? • Research regulations • Research principles and guidelines • Informed Consent 45

Informed Consent A process by which a subject voluntarily confirms his or her willingnessto participate in a particular trial, • …after having been informed of all aspects of the trial • …that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. (ICH 1.28) 46

Who Is Responsible For Performing The Informed Consent Procedure? According to the ICH GCP Guidelines 4.8.5.. “The investigator, or a person designated by the investigator, should fully inform the participant/legal representative, of all pertinent aspects of the trial……” 47

The Rules Of The Informed Consent Process ICH GCP GUIDELINES 4.8 (see attached handout) 48

No study procedures are allowed before the informed consentprocess is complete and the informed consent document is signed. 49

? Projects/Trials ? CCS BCG HIV TB HIV Neo-natal PHASE I BCG RCT Adoll. ? OBJECTIVES ? 50

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Human Rights and Health in Clinical Trials

Human rights research and teaching at the University of Minnesota spans multiple Schools and Colleges including liberal arts, public policy, law, public health, education, design, and medicine, among others. This three-part series highlights the work of our faculty specializing in health care.

Dr. Susan Craddock’s research and teaching focuses on the ethics of clinical trials in the development of pharmaceuticals, contributing to important dialogue on the relationship between human rights and medical advancements. Learn more about Susan Craddock, her work, and the ways in which she sees the right to medical advancement as a contribution to social justice and the sphere of human rights below. 

Tuberculosis is a disease which is largely concentrated in low-income countries around the world and currently undermines the health and wellbeing of approximately 10 million people . Affecting populations in India, China, the Philippines, Pakistan, Nigeria, Bangladesh and South Africa, TB is identified as being a health security threat. As the right to health is cemented into international human rights law, the United Nations has made the end of this epidemic a large component of the UN’s 2030 Sustainable Development Goals. The development of vaccines and effective treatments is central to the achievement of this goal and one whose realization involves many ethical dilemmas. Dr. Susan Craddock, through her studies on Product Development Partnerships and the development of TB vaccines, plays an important role in contributing to the conversation connecting public health to human rights in the international sphere. 

Since becoming a member of the University of Minnesota Faculty in 2001, Dr. Susan Craddock has devoted herself to investigating patterns of infectious diseases and the responses to them. She describes her work, specifically, as focusing on the “social and political aspects of global health, and particularly on infectious diseases.” Over the years, Dr. Craddock has worked on “determining variable patterns of vulnerability to particular infectious diseases… investigating the human rights issue of access to medicines… and looking at the ethics of certain kinds of clinical trials and vaccine access.” Central to such work is the investigation of the ways in which interests-- corporate, political and scientific-- influence different communities’ access to and experience with diseases.  

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In her most recent book, Compound Solutions: Pharmaceutical Alternatives for Global Health,  Dr. Craddock investigates the ethics of the development of the tuberculosis vaccine in developing countries. She explores the use of Product Development Partnerships, 21st-century nonprofit organizational structures that facilitate the funding for the development of drugs, vaccines, and other health tools as public goods. While such organizations are not driven by the same incentives as large pharmaceutical companies in the development of vaccines, they do confront a host of ethical dilemmas because of contexts of global inequality. These dilemmas include language barriers to informed consent for clinical trial participants  and the difficulties of obtaining the kinds of data that will be considered rigorous enough to attain approval (from the FDA e.g.) of a new product while not directly addressing the poverty leading to high rates of TB.

Dr. Craddock, in her research, keeps central questions of global inequality and power, insisting that a complete analysis of the ethics of vaccine development must take into account and question the reasons for which such diseases continue to be an issue in low-income regions of the world. Given that many low-income areas are affected by infectious diseases and are thus sites of research in clinical trials, Dr. Craddock points out that it is “hard to think of a clinical trial as always ethical or always fulfilling human rights because once you get into the background of  ‘why are people in this particular area so riddled with ‘x’?’, then you get into a lot of areas that are typically called human rights abuses. Whether it’s brutal colonialism, long, drawn-out negligence… [there exist] extreme inequalities that determine that some people, and not others, are going to be at risk for [infectious diseases]”.  Such a perspective has been developed and informed by her work studying the emergence and international response to the H1N1 pandemic, to clinical trials conducted on the development of tuberculosis vaccines, and by her examination of the politics shaping the AIDS pandemic.

Such attention to questions of international inequality and social justice, as they relate to patterns of infectious diseases and the responses to them, made Dr. Craddock a unique and important contributor to the Conference on Stigma, Health, and Human Rights at the University of Minnesota in 2017. Dr. Craddock looks forward to participation in similar events in the future and contributing to advocacy work done in the area of human rights through the sharing of her knowledge, both in conferences and publications. 

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[ORGANIZATION OF MEDICAL CARE FOR CHILDREN WITH A NEW CORONAVIRUS INFECTION IN PATIENT CONDITIONS ON THE EXAMPLE OF THE CHILDREN'S CITY CLINICAL HOSPITAL NAMED AFTER Z. A. BASHLYAEVA]

Affiliations.

• 1 Children's City Clinical Hospital named after Z. A. Bashlyaeva of the Moscow City Health Department, 125373, Moscow, Russian Federation.
• 2 Pirogov Russian National Research Medical University, 117997, Moscow, Russian Federation.
• 3 Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of the Russian Federation, 125993, Moscow, Russian Federation.
• 4 Pirogov Russian National Research Medical University, 117997, Moscow, Russian Federation, [email protected].
• 5 Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department, 115088, Moscow, Russian Federation.
• PMID: 34792888
• DOI: 10.32687/0869-866X-2021-29-s2-1343-1349

The article presents an analysis of the work of the largest children's COVID-19 center in Moscow, organized on the basis of the Children's City Clinical Hospital named after Z. A. Bashlyaeva of the Moscow City Health Department. From March to November 2020 at the COVID-19 Center were hospitalized 2,837 patients with suspected/confirmed diagnosis of COVID-19, in total in 2020 1,876 children with a confirmed diagnosis of COVID-19 were treated, 58 (3%) children were in serious condition in the intensive care unit, of which children 11-18 years old were 25%. At the 2020 neonatal COVID-19 center, 215 newborns were observed with suspected COVID-19 diagnosis. The diagnosis of COVID-19 was confirmed in 18 children, while 8 newborns came from the home of COVID-19. In the Center for rehabilitation, where children aged 0 to 3 years old who were born with very low and extremely low body weight are observed, dispensary observation for children who have undergone COVID-19 is organized. 45 children who were observed fell ill with the new coronavirus infection. There were no deaths among children with COVID-19.

Keywords: COVID-19; COVID-center; children; new coronavirus infection; newborns; treatment.

• COVID-19 Testing*
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