Draft Policy Recommendations Self-directed Interactive Review
Category 3: Researchers - Professional Education and Publications
These policy recommendations are primarily aimed at ensuring that all professions participating
in clinical research have the appropriate knowledge, skill and motivation to ensure inclusion of
underrepresented populations.
Attention is also paid to how professional publications can create incentives for researchers to
achieve inclusion.
Section 1: Publications
Background:
While there is evidence that populations that bear disproportionate burdens of disease are
consistently underrepresented in clinical trials, discussions of diversity, inclusion, and
representation in clinical trials are often missing from the subsequently published studies. This
is unfortunate because frank scholarly discussion of disparities represents a significant learning
opportunity both for the investigators themselves and for the general readership.
While there are uniform requirements regarding biomedical publications from at least
two different bodies - the International Committee of Medical Journal Editors, or "ICJME," and
the World Association of Medical Editors or "WAME" - neither addresses the problem of
disparities in clinical trials. Moreover, the rationale for eliminating disparities in clinical trials
on grounds of social justice, scientific rigor, and business interests has not been made clear to
journal editors, academic medical centers, private sponsors of clinical trials, and investigators
themselves.
Increasing awareness of the problem of disparities in clinical trials is a first step to
eliminating them. Urging enhanced dialogue and analysis of the issue in connection with
publications is an important means of raising awareness.
Policy Recommendation 1: Disparities & Publications
Because publications provide a forum for raising and analyzing disparities in clinical
trials, they are integral to eliminating such disparities. The EDICT Team therefore recommends
that the ICMJE and the WAME adopt editorial standards that require investigators to include in
their manuscripts analysis of whether the subject population's demographics corresponds to the
demographics of the population that bears the disease burden.
Rationale behind this recommendation:
While most published studies are products of clinical trials that did not feature
appropriate representation, most studies also do not discuss the inclusiveness or lack thereof of
the relevant trials. This results in the loss of a significant learning opportunity. At a minimum,
frank and open disclosure of a trials' success or failure to recruit and retain subjects who are
members of populations that bear the relevant disease burden would increase dialogue and
awareness of the widespread disparities within clinical trials.
Moreover, ensuring appropriate representation between the subject population and the
population that bears the disease burden would result in higher quality publications. In general,
the clinical trial should provide evidence of applicability of the intervention across the entire
patient population. In other cases, a clinical trial is designed to provide evidence of the effect of
an intervention in a specific target population (whether identified by race, ethnicity, gender,
disability status, or age). Therefore, clinical trials with diverse representation assure better
scientific evidence, which can then be translated into better clinical practice, and provide greater
benefit to the public.
Finally, biomedical journals have been an important source of information and criticism
regarding past research abuses. Henry Beecher's famous 1966 article detailing such abuses at
major academic centers was a significant stepping stone on the path to formal regulation of
clinical research.1 Unfortunately, many of the same populations that are underrepresented in
clinical trials are victims of past research abuses. Accordingly, U.S. and global leaders in setting
publication standards can play a crucial role in ensuring that the benefits of biomedical research
are distributed justly, especially to populations that have been subjected to unethical research in
the past.
Policy Maker Focus: While a number of different stakeholders have the potential to change
behavior in this area, arguably journal editors enjoy the most direct ability to do so. Given that
the ICMJE and the WAME set standards for biomedical journals worldwide, they are a key
player in implementing policy that could raise awareness and enhance analysis of disparities in
clinical trials.
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Section 2: Clinical Research Training Programs (CRTP)
Background:
Federal regulations require all investigational teams who conduct research with federal
funding take human subjects research training. However, many academic medical centers and
research institutions have viewed these regulations as a floor rather than a ceiling, and, in any
case, only 30% of clinical trials are federally funded.2 Thus, these centers and institutions have
responded to the need for supplemental training by creating their own education programs on the
ethical and legal conduct of human subjects research.
While such programs typically cover the responsible conduct of clinical research, it is
rare that such programs explain the current state of disparities in clinical trials. Nor is it common
for training programs - whether intended to satisfy regulatory or institutional requirements - to
address means of ameliorating these disparities. Because clinical research educational programs
are so widespread, they represent attractive sites for introducing educational requirements and
learning objectives related to disparities in clinical trials.
Policy Recommendation 1: Incorporate Disparities Education into CTRP
Because the elimination of disparities in clinical trials is unlikely to occur without educating
investigators on the ethical and scientific advantages of reducing disparities, the EDICT Team
recommends that institutions that mandate research training experience include modules that:
(1) address the existence and current problems regarding disproportionate representation of
underrepresented populations in clinical trials;
(2) explain why the amelioration of disparities in clinical trials constitutes both good science
and good ethics; and
(3) suggest practical strategies for recruiting and retaining members of underrepresented
populations in clinical trials.
Rationale behind this recommendation:
Presumably, many academic medical centers and research institutions mandate clinical
research education that emphasizes the responsible conduct of scientific research because of an
understanding that such education promotes both ethics and science. As numerous authorities
explain, the research enterprise in general founders without sufficient public trust that human
subjects research will be conducted in accordance with ethical precepts. That public trust is part
and parcel of high-quality science, because erosion of that trust makes human subjects research
infinitely more difficult.
Nowhere is this dynamic more evident than in the current problems regarding disparities
in clinical trials, in which a variety of underrepresented populations are underrepresented in clinical
trials. One of the most commonly cited barriers to increasing members of such populations'
participation is mistrust in the research enterprise in general.
Without educating investigators on the current problems regarding these disparities,
progress is rendered far more difficult because it is the investigators who have the means to
design studies with built-in measures designed to increase enrollment of members of underrepresented
populations. Education of investigators should also explain why increasing such participation is
not simply an ethical imperative, but produces better science insofar as a subject population that
displays such disparities will not resemble the targeted patient population, whether that
population is the general public or a specific community. Finally, such education can suggest
practical strategies for recruiting and retaining members of underrepresented populations in clinical
trials, thereby equipping investigators with the needed tools.
Institutions that already mandate such research training are exceptionally positioned to
supplement these programs with modules specifically designed to ameliorate disparities in
clinical trials.
Policy Maker Focus: Clinical Research Training Programs
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Section 3: Medical Education on Disparities (LCME)
Background:
Students are graduating from medical school without sufficient knowledge of how health
care disparities are manifested in clinical research. Formal research training-especially clinical
research training-is scant in medical education curricula, and medical schools' curricula that
address health care disparities are frequently limited and offered as electives. Opportunities to
participate in clinical research projects that enroll underrepresented patient populations are designed
without sensitivity to cultural, linguistic, and other patient concerns, and model interdisciplinary
teamwork is rare. And the effects of the "hidden curriculum" and medical students, interns, and
residents often undermine educational efforts to address physicians' behaviors and attitudes that
contribute to health care disparities in clinical research.
Policy Recommendation 1: Disparities & Medical Education
Because enhancing education of students, investigators, and other professionals is vital to
ameliorating disparities in clinical trials, the EDICT Team recommends that the Liaison
Committee for Medical Education amend standard II.B.2, which
addresses education regarding clinical research, so as to include specific learning objectives
related to the manifestations of health care disparities in clinical and translational research.
Rationale behind this recommendation:
Part of the difficulty in ameliorating disparities in clinical trials is that those professionals
who are positioned to mollify the problem often lack understanding of both the problem and
potential remedies, while those who understand the problem and means to ameliorate it are often
ill-positioned to do so (i.e., they may not participate in clinical research). This recommendation
addresses the former problem. The hope is that by enhancing the ways in which professionals
are educated, more and more of those who conduct clinical trials will apprehend the widespread
disparities in clinical trials, as well as their responsibility and their ability to effect change.
While this recommendation addresses medical education, the EDICT Team believes that an
analogous recommendation would be appropriate for accreditation bodies that credential health
professionals. Medical students and trainees are targeted here at least in part because physicians
remain the most likely party to be principal investigators.
While leaders in medical education are beginning to address the holes in medical
curriculum regarding biomedical research in general, any attempts to do so which do not include
specific learning objectives regarding disparities in clinical trials are suboptimal. Medical school
and allied health school faculty and curriculum "managers" need to be given the mandate and the
tools necessary to design, evaluate, and implement curricular interventions that address clinical
research skills and the topic of health care disparities. Preceptors, residents, and principal
investigators with responsibility for students' education also need to be trained to effectively
teach these curricula.
Finally, given the importance of the "hidden curriculum" in educating students, new
physicians must be given the opportunity to shadow physician-scientists in clinical research that
model practices for eliminating disparities. Revising the LCME standards so as to specifically
mandate education regarding disparities in clinical trials offers one tool for building into medical
education awareness of the problem as well as capacity for redressing it.
Policy Maker Focus: Clinical Research Training Programs
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Section 4: Graduate Medical Education on Disparities
Background:
Residents are crucial to the goal of eliminating disparities in clinical trials because they
are often a patient's first source of information regarding clinical trials. Educating residents that
increasing proportionate representation in clinical trials makes for better science and for better
ethics and is therefore a core element of the EDICT project.
In graduate medical education for residents, there is little to no formal training about
clinical trials in general or disparities and the need for diversity in clinical trials recruitment. In
1999, the Accreditation Council for Graduate Medical Education (ACGME) endorsed general
competencies for residency training (see ACGME document).
In theory, several of the generic competencies overlap concern for increasing recruitment
and retention of minority and other under-represented groups for clinical trials. However, none
of the terms "research," "clinical trials", "minorities", or "disparities" appear among either the
short or full versions of the competencies. For that matter, the ACGME Core Competencies do
not include specific requirements for training in understanding and interpreting research or
criteria for evidence based research as, for example, maintained by the U.S. Preventive Services
Task Force criteria for evidence based medicine (see USPSTF criteria).
Over the past seven years, the ACGME has developed a variety of tools to help
implement as well as assess the Core Competencies, including materials on evidence based
medicine and cultural competence, to cite only two that could impact recruitment of patients to
clinical trials. It is therefore reasonable to incorporate materials on diversity and disparities in
clinical trials research into the existing framework of the Core Competencies.
Policy Recommendation 1: Disparities & Graduate Medical Education
Because provider education is vital to ameliorating disparities in clinical trials, the EDICT Team
recommends that residency training programs incorporate the following elements into the formal
curriculum of their programs:
- The existence of disparities and the need for diversity in clinical trials;
- Basic principles of research as they impact evidence based medicine as well as the
acceptability and appropriateness of research findings for diverse populations;
- Awareness of available clinical trials for which their patients, especially those from
underrepresented groups, may be eligible;
- Awareness of how lack of cultural competence impacts both patient care and recruitment
to clinical trials;
- Awareness of Culturally and Linguistically Appropriate Services (CLAS) Standards as
they impact both patient care and clinical trials recruitment.
Rationale behind this recommendation:
Physicians in practice are a cornerstone for referral and recruitment to clinical trials.
Physicians in practice tend to consider as priorities those categories of medicine to which they
were exposed in their training. However, because neither residents nor physicians in practice
receive systematic or consistent training in the issues related to disparities and the need for
diversity in clinical trials recruitment, these concerns are not salient as they provide patient care,
even when it would be appropriate to engage patients in discussion about appropriate clinical
trials for which patients may be eligible.
Because residents also are primary teachers in the clinical context of medical students'
training, it is equally important for them to both model and reinforce culturally and linguistically
appropriate approaches to patient care and clinical trials research.
Policy Maker Focus: Accreditation Council for Graduate Medical Education
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Section 5: Continuing Medical, Nursing and Other Healthcare Education
Background:
Health professionals are crucial to the goal of eliminating disparities in clinical trials
because they are often a patient's first source of information regarding clinical trials. Educating
health professionals such as physicians, nurses as well as other members of the health care team
that increasing proportionate representation in clinical trials makes for better science and for
better ethics is a core element of the EDICT project.
For example, in continuing medical education (CME) for physicians in practice, there is
little to no formal training about clinical trials in general or disparities and the need for diversity
in clinical trials recruitment. Physicians also do not receive such training during residencies. In
continuing medical education ("CME"), neither the Accrediting Council for Continuing Medical
Education (ACCME), nor the American Academy of Family Physicians (AAFP), which
maintains a separate CME accreditation process for family physicians, specifically address issues
related to diversity or disparities in clinical trial recruitment. However, nothing precludes raising
these issues in appropriate CME contexts.
Policy Recommendation 1: Education for Healthcare Professionals
Because education is vital to ameliorating disparities in clinical trials, the EDICT Team
recommends that continuing professional education providers incorporate the following elements
into their programs:
- The existence of disparities and the need for diversity in clinical trials;
- Basic principles of research as they impact evidence based medicine as well as the
acceptability and appropriateness of research findings for diverse populations;
- Awareness of available clinical trials for which their patients, especially those from
underrepresented groups, may be eligible;
- Awareness of how lack of cultural competence impacts both patient care and recruitment
to clinical trials;
- Awareness of the OMH Culturally and Linguistically Appropriate Services (CLAS)
Standards as they impact both patient care and clinical trials recruitment.
Rationale behind this recommendation:
Health professionals in practice are a cornerstone for referral and recruitment to clinical
trials. Physicians, nurses and other health professionals in practice tend to consider as priorities
those categories of medicine to which they were exposed in their training. However, because
health professionals in practice do not receive systematic or consistent training in the issues
related to disparities and the need for diversity in clinical trials recruitment, these concerns are
not salient as they provide patient care, even when it would be appropriate to engage patients in
discussion about appropriate clinical trials for which patients may be eligible.
Policy Maker Focus:
Accrediting Council for Continuing Medical Education (ACCME), the American Academy of
Family Physicians (AAFP) or other relevant bodies for continuing professional education in the
various healthcare fields.
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1 Henry K. Beecher, Ethics and Clinical Research, 274 N. ENGL. J. MED. 1354 (1966).
2 See General Accounting Office, NIH Clinical Trials: Various Factors Affect Patient Participation 1, 4 (1999),
available at http://www.gao.gov/archive/1999/he99182.pdf (last accessed August 18, 2007); see also Hamilton
Moses III, E. Ray Dorsey, David H. Matheson, and Samuel O. Thier, Financial Anatomy of Biomedical Research,
294 JAMA 1333, 1335 (2005).
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