Copyright, 1996 © Dale Carnegie & Associates, Inc.

CLINICAL TRIALS AND HUMAN SUBJECT

PROTECTION:

A PLAINTIFF’S PERSPECTIVE

ALAN MILSTEIN SHERMAN SILVERSTEIN KOHL ROSE & PODOLSKY WWW.SSKRPLAW.COM

THERAPY VS. RESEARCH

EXPERIMENTAL THERAPY VS EXPERIMENT

NONTHERAPEUTIC RESEARCH CLINICAL TRIALS CHALLENGE STUDY

THERAPEUTIC RESEARCH NEW VS. EXISTING THERAPY NO THERAPEUTIC ALTERNATIVE

ETHICAL REQUIREMENTS

NUREMBERG CODE HELSINKI DECLARATION BELMONT REPORT THE COMMON RULE FUNDAMENTAL RIGHT TO BE

TREATED WITH ESSENTIAL HUMAN DIGNITY

WHY ALL THE CONTROVERSY?

DEATH OF JESSE GELSINGER

DEATH OF ELLEN ROCHE

DEATH OF NICOLE WAN

UNIVERSITY OF OKLAHOMA

MELANOMA TRIAL

THE MYTH 0F SUBJECT PROTECTION: EVERYBODY’S WATCHING

THE TRUTH: THE RESEARCHER’S ETHICS Currently more than 100,000 trials involving 7-

8,000,000 participants At some major institutions, 4000 current trials 5000 IRBs

THE SOLUTION

Reduce the number of trials; stop trivial research; devote resources to subject protection

CONFLICTS OF INTEREST

THE TRUTH Financial and other interests that potentially take the

focus away from protection of the subject cannot be managed.

THE SOLUTION Institutions and researchers should have no financial

stake in the outcome of an experiment or in the decision of the subject to participate.

EXPERIMENT MUST BE ETHICALLY DESIGNED

PRECLINICAL UNDERSTANDING OF UNIVERSE OF HARM

VALID SCIENCE: LIKELIHOOD OF GAINING KNOWLEDGE

VALUABLE: FRUITFUL RESULTS FOR GOOD OF SOCIETY

RISKS MINIMIZED AND OUTWEIGHED BY BENEFITS NONTHERAPEUTIC: SHOMEIR P’TAYIM THERAPEUTIC: CLINICAL EQUIPOISE

ETHICAL USE OF PLACEBOS

SELECTION CRITERIA

MUST BE EQUITABLE ABSENCE OF COERCION AVOIDS VULNERABLE POPULATIONS

INFORMED CONSENT

PURPOSE PROCEDURE RISKS BENEFITS SELECTION ALTERNATIVES FINANCIAL INTERESTS

UNINFORMED CONSENT:THE MYTH OF INFORMED CONSENT

THE TRUTH: The document neither evidences the participant is informed or that he or she consents.

THE DOCUMENT

• Presumes Consent vs Informed Choice• Study/Clinical Trial/Research• Average time: 10 minutes• Conveyed and Understood• Competent to give consent• Whose role?

Therapeutic Misconception

70% believed proven best treatment 50% believed standard treatments and

procedures 70% believed best therapeutic alternative 90% believed purpose to benefit them not

future patients

National Cancer Institute: Reasons to Enroll

o Access to new drugs and interventions before widely available

o Opportunity to be the first to benefit if approach found helpful

o Better care than standard best therapyo Often the best therapeutic alternative

SOLUTIONS

Tell it like it is: A human experiment Use subject advocates Explain Phase 1, Phase 2, Phase 3 Know whether best therapeutic alternative Stop selling

RESPONSIBLE PROTECTORS OF HUMAN SUBJECTS

Investigators IRB members Subject Advocates OHRP RAC FDA All Of Us