Do the Right Thing: Good Clinical Practice for Clinical Research

Transcription

1 Do the Right Thing: Good Clinical Practice for Clinical Research Andrew A. Nierenberg, MD Director, Bipolar Clinic and Research Program, Director, Training and Education, MGH Research Institute Massachusetts General Hospital Professor of Psychiatry, Harvard Medical School

2 Thanks for Barbara E. Bierer, M.D. for some slides

3 Andrew A. Nierenberg, MD Disclosure Statement Employee Of Consultant For Stockholder In Grant Support From Honoraria From Massachusetts General Hospital Abbott Laboratories, Astra Zeneca, Basilea, BrainCells Inc., Bristol- Myers Squibb, Cephalon, Clintara, Corcept, Eli Lilly & Co., Forest, Genaissance, Genentech, GlaxoSmithKline, Hoffman LaRoche, Innapharma, Janssen Pharmaceutica, Jazz Pharmaceuticals, Lundbeck, Medavante, Merck, Naurex, Novartis, PamLabs, PGx Health, Pfizer, Roche, Sepracor, Schering-Plough, Shire, Somerset, Sunovion, Takeda, Targacept, Teva Appliance Computing, Inc. (MindSite); Brain Cells, Inc., Medavante AFSP, AHRQ, Bristol-Myers Squibb, Cederroth, Cyberonics, Forest Pharmaceuticals, GlaxoSmithKline, Janssen Pharmaceutica, Lichtwer Pharma, Eli Lilly, NARSAD, NIMH, Pfizer, Shire, Stanley Foundation, Wyeth-Ayerst MGH Psychiatry Academy in the past 3 years (Prior to 3 years ago, honoraria from Bristol-Myers Squibb, Cyberonics, Forest Pharmaceuticals, GlaxoSmithKline, Eli Lilly,, Shire, Wyeth-Ayerst), No speaker bureaus since 2003

4 Andrew A. Nierenberg, MD Disclosure Statement Other Income MBL Publishing for past services as Editor-in-chief of CNS Spectrums; Slack Inc. for services as Associate Editor of Psychiatric Annals; Editorial Board, Mind Mood Memory, Belvior Publications Patents and Copyrights Copyright joint ownership with MGH for Structured Clinical Interview for MADRS and Clinical Positive Affect Scale Additional Honoraria ADURS, Brain and Behavior Foundation Colvin Prize, University of :Pisa, University of Wisconsin at Madison, University Texas Southwest at Dallas, Health New England and Harold Grinspoon Charitable Foundation and Eli Lilly and AstraZeneca, American Society for Clinical Psychopharmacology and Zucker Hillside Hospital and Forest and Janssen, Brandeis University, International Society for Bipolar Disorder

5 What does it mean to do the right thing?

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8 Hebrew Bible

9 Talmud

10 New Testament

11 Quran

12 Baruch Spinoza

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14 Spike Lee

15 Leaders are people who do the right thing; managers are people who do things right. Warren Bennis Read more at tml#mwfe4f4htmuzo3kd.99

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17 Dharma

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19 NYT May 26, 2015 Fraud in a drug study Enrolling illiterate Hmong refugees in a drug study without their consent. reckless, if not willful, disregard for dozens of patients; in a clinical trial

20 NYT Editor Picks Comments swm Providence, RI..This mistreatment of the participants in these drug studies is appalling, if not criminal. As a person who conducts research with human subjects, I consider the treatment of each individual to be sacrosanct and if there are researchers who are mistreating their subjects they should be banned from conducting research.

21 Everyone s health What s at stake?

22 How to do the right thing Learn and know the regulations Comply with the regulations Act ethically always Use your moral compass For yourself For the others around you Seek help

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24 Institutional support for Good Clinical Practice Commitment to the Belmont principles Respect Beneficience Justice And beyond: The community and the public

25 How can we help? Support of and to the IRB Division of Clinical Research at MGH Human Research Program at BWH Education and training Compliance and monitoring Continuous quality improvement

26 What issues will you encounter? Privacy Informed consent Integrity Interactions with participants Every data point Trust

27 The mandate for quality in Clinical Research Ensure the ethical treatment and protection of research participants Uphold public trust in the integrity of clinical research and research conduct And thus: Strive for compliance with regulatory requirements Improve the efficiency, quality and impact of clinical research process and performance

28 Concerns Research misconduct (as defined by 42 CFR Part 93) Falsification (making up results and reporting them) Fabrication (manipulating research materials, data, or processes; or manipulating data such that the research is not accurately represented in the record) Plagiarism (the appropriation of another person s ideas, results, or words without giving that person appropriate credit)

29 Concerns An honest difference of opinion or an honest error can result in the occurrence of isolated noncompliance (including GCP noncompliance). This is NOT research misconduct. Misconduct requires deliberate or repeated noncompliance Ignorance Sloppiness Falsification/Fraud Unintentional Intentional

30 PI Responsibility Ensure data validity Ensure data are clear, interpretable, and maintained Meet with the research and staff associates to review progress and data regularly PIs should establish clear practices for all practices Look at the data Look at the documentation Question what you see The single most important tool is Source Documentation Even if it annoys others Even if inconvenient Even if you need support And, if you don t have time Assign the responsibility to someone who does

31 Image source: Jason Tester.

32 Support Your IRB administrator QA/QI service Office of Interactions with industry Research compliance Mary Gervino, MGH Allison Moriarty, BWH And your Senior Vice Presidents Harry Orf, MGH Paul J. Anderson, BWH

33 Today you will hear Good clinical practice (GCP) approaches Necessary for industry sponsored trials Monitored (Clinical Research Organization, other) Essential for data integrity Essential for investigator-initiated trials Risks potentially higher Less obvious support Time proven approach to data integrity and reliability

34 Today you will hear IRB, consenting processes, reporting, adverse event reporting, quality assurance, monitoring Research integrity, and misconduct (Office of interactions with Industry)