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Eliminating Disparities in Clinical Trials

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Conclusion: '...[T]he working group does not find evidence of barriers to the ... working groups (Opportunity Teams) will craft policy recommendations by Fall of 2007. ... – PowerPoint PPT presentation

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Title: Eliminating Disparities in Clinical Trials


1
Eliminating Disparities inClinical Trials
  • Dan Bustillos, J.D., Ph.D. (c).
  • Postdoctoral Fellow, IRB member.
  • Baylor College of Medicine
  • Adjunct Professor of Law,
  • Health Law Policy Institute,
  • University of Houston Law Center

2
Objectives for this presentation
  • Review the history of human subjects research
    (HSR) in the modern era
  • Identify the social justice issues
  • Review Baylor College of Medicines E.D.I.C.T.
    Project

3
HSR Ethics in the 19th Century
  • While the field of Medical Ethics existed in
    the Nineteenth Century, it roughly followed the
    same male-centered, paternalistic lines of
    medical science.
  • There was no need to ask for a patients consent,
    after all, the physician knew best.

4
HSR Ethics in the 19th Century
  • This is not to say that these issues werent
    already being vehemently debated.
  • The first American document dealing with the
    ethics of human subject research (HSR) was
    published by William Beaumont in 1833.

5
HSR Ethics in the 19th Century
  • In 1865, world-renowned French physiologist
    Claude Bernard saidnever perform on man an
    experiment which might be harmful to him to any
    extent, even though the result might be highly
    advantageous to science.-An Introduction to the
    Study of Experimental Medicine (1865)

6
Setting the stage
  • Late 1800s Darwinian evolutionary theory
    devolves into Social Darwinism
  • a thinly-veiled racism.
  • Many men of medical science see women, children,
    the disabled, and minority racial groups as akin
    to the animals whose most noble purpose is to
    serve mankind as research subjects.

7
HSR Ethics in the 19th Century
  • 1880-1910 African-American myth of Night
    Doctors traced to fears of medical
    experimentation in the years following the Civil
    War.
  • 1891 Infecting healthy breast tissue with
    cancerous grafts to determine if cancer was
    contagious.

8
History of Research on the Disadvantaged
  • Early in the Twentieth Century, some physicians
    cited the considerable cost of acquiring and
    maintaining animal research subjects, to justify
    experimentation on orphaned children instead.
  • Orphans, the mentally disabled, and foreign
    immigrants were often exploited at the turn of
    the century.

9
Legal Bases for Research Participant Protections
  • 1914 Schloendorff v. Society of New York
    Hospital,
  • Justice Benjamin Cardozo Every human being of
    adult years and sound mind has a right to
    determine what shall be done with his own body.
  • Established the doctrine of assault for
    unauthorized or unconsented to medical
    intervention.

10
Legal Setbacks for HSR Protections
  • In 1902, bills were introduced to regulate human
    subject research in America.
  • Arguing that this would stunt medical progress,
    the bills were defeated.

11
Informed Consent
  • The birth of informed consent Walter Reeds
    yellow fever experiments in Cuba and Panama.
  • Unfortunately, the documents de-emphasized the
    risks and exaggerated the inevitability of
    naturally contracting the disease.

12
HSRs Golden Age
  • 1900-1940s Medical research flourishes in
    America.
  • While many protest scientific abuse, America is
    caught up in a progressivist, industrial age
    whose medical discoveries appear as being fueled
    by little regulation.
  • Medical Triumphalism rules the day

13
  • Tuskegee Study

14
The last 100 years
  • Tuskegee Syphilis study begins 1932
  • Nazi experiments in WWII.
  • Nuremburg Trial 1946
  • The Nuremburg Code 1947
  • Thalidomide tragedy 1960s
  • Tuskegee study exposé 1972
  • The Belmont Report 1979
  • Consolidated HHS/FDA regulations 1981
  • Common Rule 1991

15
The Pendulum Swing
  • While originally the disadvantaged (women,
    children, poor, immigrant, physically and/or
    mentally challenged, etc.) composed a far too
    great percentage of those enrolled in medical
    research, now the pendulum has swung in the
    opposite direction.

16
The Pendulum Swing
  • 1993 NIH Revitalization Act
  • Mandated the inclusion of Women and Minorities in
    Clinical Trials.
  • Designed to bring the Pendulum back to the
    center.
  • Designed to enhance the science.

17
The Pendulum Swing
  • 1997 FDA Modernization Act
  • Required that the Director of Center for Drug
    Evaluation and Research (CDER) convene a working
    group to advise on the problem of
    underrepresentation in clinical trials.
  • Conclusion ...The working group does not find
    evidence of barriers to the enrollment of
    minorities in clinical trials that are regulatory
    in nature or could be addressed by regulatory
    guidance.

18
Project EDICT
  • A 4-year collaboration between BCM, Intercultural
    Cancer Council.
  • Funded by Genentech, Inc.

19
Organizing Framework
  • The Three Rs
  • Recruitment - In addition to issues of active
    recruitment, this R also includes issues of
    access.
  • Retention - Keeping participants satisfied and
    on protocol.
  • Return - Giving back to our participant
    populations.

20
Recruitment
  • The 2005 AHRQ report on the recruitment of
    underrepresented populations to cancer clinical
    trials identified 118 barriers to effective
    recruitment including barriers to opportunity,
    awareness, and acceptance. Only 59 promoters of
    enrollment were identified in the literature.
  • There is a lack of effective recruitment
    stratagies reported in the literature
  • There is also a lack of relevant clinical trial
    availability for these groups

21
Retention
  • While there are few studies devoted to the
    problem of retaining the underrepresented in
    clinical trials, there remains plenty of room for
    policies that enhance the overall experience of
    participants in clinical trials and remove all
    manner of barriers to their continued
    participation.
  • E.g. Culturally-appropriate care.

22
Return
  • Should the clinical trial enterprise provide for
    the continued benefit to underrepresented
    populations and their communities?
  • Should communities that make medical research
    possible be rewarded for their participation with
    continued access to FDA-approved drugs and
    biologics?

23
Return
  • The clinical trial enterprise should forge
    relationships with under-represented
    communities.
  • These bonds can then be a platform from which
    future patients will be encouraged to participate
    in clinical trials.
  • This will in turn benefit the clinical trials
    enterprise a symbiotic relationship is formed.

24
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25
A Year Into The Project
  • We conducted a thorough literature review in the
    areas of law, ethics, and policy.
  • We convened a large Roundtable comprised of 150
    stakeholders. Diversee perspectives enriched the
    dialogue.
  • The Roundtable spawned 10 Opportunity Teams
    organized around different facets of the issue.

26
The Next Year Of The Project
  • Our Policy-oriented working groups (Opportunity
    Teams) will craft policy recommendations by Fall
    of 2007.
  • Next phase begins Policy Dissemination/
    Implementation phase.
  • April 2008 Large-scale Public Rollout of policy
    recommendations/ EDICT Recognition Program
    /Policy successes, at ICC Biennial Conference, DC

27
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