Draft Policy Recommendations Self-directed Interactive Review
Category 4: Community - Participation
These policy recommendations relate to creating full community participation in the
design and implementation of clinical trials.
Section 1: Outreach
Background:
Two of the primary barriers to increasing participation in clinical trials are
mistrust and lack of awareness of clinical trials. Mistrust is particularly prevalent among
underrepresented populations such as women, the elderly, and racial and ethnic minorities.
Sadly, many of these populations have sound historical reasons for such mistrust. As to
lack of awareness, one survey found that 80% of respondents were unaware that they
were eligible to participate in a clinical trial related to their illness.1
One possible means of ameliorating both mistrust and lack of awareness is
enhancing educational opportunities regarding clinical trials for the public.
Notwithstanding the legitimate basis for some underrepresented populations' mistrust of
clinical trials, many persons may also harbor various fears and misconceptions regarding
clinical trials.2 These fears could be assuaged with effective education. Moreover, the
obvious remedy for the general lack of awareness of clinical trials is to increase such
awareness via enhanced education.
Finally, information on clinical trials and the clinical trial process is available but
is often underutilized, and may also be written in such a way that the average individual
cannot understand it.
Policy Recommendation 1: Communication Plans
Because enhancing patient and public understanding of clinical trials is integral to
ameliorating disparities in such trials, the EDICT Team recommends that all sponsors of
clinical trials require:
a) the development and implementation of culturally appropriate recruitment and
retention plans with an additional focus on community education provided in appropriate languages for non-English and limited-English speaking populations.
Such plans should reflect the cultural and ethnic diversity of the populations at the
sites to stimulate the local recruitment and retention of appropriate numbers of racial and ethnic minorities, women, and other medically underrepresented patients as trial participants.
Rationale behind this policy recommendation:
It is striking that in spite of the general consensus that mistrust and lack of awareness are significant barriers to clinical trial participation, organized, systematic efforts to enhance patient and public education are infrequent. Increasing such participation among underrepresented populations is particularly important insofar as many underrepresented populations (e.g., women, the elderly) bear a disproportionate burden of disease. Enhancing education as to clinical trials may increase participation in general both by simply increasing awareness of clinical trials and by promoting trust between subjects and researchers.
However, these goals are also essential to ameliorating disparities in clinical trials. This is because both mistrust and lack of awareness of clinical research constitute significant barriers to increasing members of underrepresented populations’ participation in clinical research. One way of increasing both the utilization and the quality of such education is to encourage sponsors of clinical research to require all research teams seeking funding include in their protocols specific communication plans for educating members of underrepresented populations.
This process should be based on evidence-based research or promising practices so as to increase the likelihood of successful communications. Furthermore, continued and future funding should be made dependent, in part, on evaluation of the outreach/education methods, thereby further ensuring evidence-based practice. The EDICT Project’s BackPack research, which is intended to assess best practices in reducing disparities in clinical trials, may facilitate the identification of best practices regarding public education.
Inclusion, participation of the underrepresented in clinical trials can ultimately reduce cost and resources necessary to conduct population-relevant clinical trials and accelerate enrollment into these trials. )
Policy Maker Focus: Public, private and non-profit sponsors of clinical trials.
click here to submit your feedback on this policy recommendation
Policy Recommendation 2: Community Advisory Boards
Because enhancing patient and public understanding of clinical trials is integral to
ameliorating disparities in such trials, the EDICT Team recommends that all sponsors of
clinical trials require:
(b) that all local clinical trial teams convene a community advisory "recruitment and
retention committee" to inform, evaluate, and advise on participation of
underrepresented populations.
Rationale behind this policy recommendation: as for previous recommendation
Policy Maker Focus: Public, private and non-profit sponsors of clinical trials.
click here to submit your feedback on this policy recommendation
Section 2: Community Participation - Capacity
Background:
There is a disconnect between research institutions and the communities where
they conduct clinical research. Part of that disconnect is cultural and systemic. Clinical
trials are part of the larger picture of clinical research. We believe that communities must
be involved in the entire clinical research process. To be effective, involvement with
communities must begin before a trial and continue after the trial is completed. We define "community" as "those whose well-being is likely to be affected
by the conduct of the research." From Building Community Partnerships in Research,
Recommendations and Strategies, Report to the President from the Secretary, Health and
Human Services, February 1998.
Authentic community participation (as opposed to representation) in the clinical
trial process is rare, which tends to exacerbate disparities in clinical trials and outcomes.
Such disparities result in research findings that may not be applicable or generalizable to
all segments of the population. This in turn results in less robust knowledge, less
effective clinical outcomes, and fewer options for segments of the population.
Several significant factors result in minimal community participation in clinical
trials.
First, there is insufficient gender, racial and ethnic diversity among clinical
researchers, compounded by a lack of understanding of context on the part of researchers.
Researchers typically lack critical contextual data about the communities that will assure
a more community-specific design. While information about quality of life exists, it is
often discounted because it is qualitative and not quantitative. The data explaining what
it is like to live in a particular underrepresented community exists, but is rarely sought and
when identified it is often discounted. This is both because it is qualitative and because
members of the research community do not see the need to consider cultural and
community norms in clinical trials. Researchers may acknowledge these limitations exist
however, they are not reflected in the actionable results published.
Second, there is a failure to disseminate clinical research findings to those who
participated in the trial and to the community as a whole. This is perceived as
disrespectful and diminishes the value of its investment. This promotes distrust and
perpetuates the barriers to community participation.
Third, clinical studies fail to provide for the creation of infrastructure within the
community to support residents over the long term. Building ongoing capacity in the
community is important both to increase community participation and to eliminate
disparities in clinical trials.
The collective experience of the team confirms that community participation in
clinical research is critical and will contribute significantly to the elimination of
disparities in clinical trials.
Policy Recommendation 1: Capacity-Building
Because increasing community participation is crucial to eliminating disparities in
clinical trials, the EDICT Team recommends that public and private sector sponsors
require that all proposals for clinical trials considered for funding
- demonstrate methods and measures to ensure meaningful community
participation throughout the clinical trial process, and
- include a detailed plan to build community capacity for understanding and
supporting clinical research. (For example, these might include an ongoing
participant navigation program, community training and education as well as
equipment, facilities, and other resources that enhance access to healthcare
services.)
Rationale behind this recommendation:
To enroll and retain proportional representation in clinical trials, a new system of
community engagement and representation is required. A system that includes
community-based participatory research principles will leverage the expertise,
experience, and motivation of "those whose well-being is likely to be affected by the
conduct of the research." These principles include:
The recognition of the community as an unit of identity:
- Builds on strengths and resources within the community
- Facilitates collaborative, equitable involvement of all partners in all phases of the
research
- Integrates knowledge and intervention for mutual benefit of all partners
- Promotes a co-learning and empowering process that attends to social inequalities
- Involves a cyclical and iterative process
- Addresses health from both positive and ecological perspectives
- Disseminates findings and knowledge gained to all partners
- Involves long-term commitment by all partners.3
There are multiple reasons to incorporate community-based participatory research
principles in clinical trials.
- Community participation can increase each community's readiness and
willingness to participate in the clinical trials process when grassroots
community members are engaged in the decision-making process at all
levels and phases including the planning and implementation stages. Helping people to become informed and educated about the clinical trials
process is essential to recruitment and retention of participants.
- Participation can help build trust between the community and researchers
where mistrust often exists. This is particularly important given the
documented abuses of human subjects.
- It builds greater understanding of the clinical trials process and the
contributions communities can make in bringing new treatments to the
public.
- Enhanced community participation results in increased opportunities for
community members to assume more meaningful roles in the entire
clinical trials process.
- Community participation promotes individual retention in trials because
participants are better informed and have the support of the community.
In such circumstances, participants' commitment would be motivated by
the desire to make a contribution to the health of their community.
- Community members with experience in the clinical trials process can
help identify what research needs to be done as well as assist in the
planning and implementation of clinical trials.
Policy Maker Focus: Public and private sector sponsors of clinical trials
click here to submit your feedback on this policy recommendation
Section 3: Community Participation - Community Education
Background: See background above for Community Participation - Capacity
Policy Recommendation 1: Community Education
The EDICT Team recommends that community organizations and individuals, as equal
partners in the process, should:
- Develop and implement plans to actively disseminate information about
research outcomes, new policies, and new knowledge to community members,
and
- Develop ongoing relationships with individual researchers and with research
institutions to promote meaningful dialogue that ensures community
involvement.
Rationale behind this policy recommendation: same as for previous recommendation
Policy Maker Focus: Community organizations and individuals
click here to submit your feedback on this policy recommendation
1 National Cancer Institute, "Doctors, Patients Face Different Barriers to Clinical Trials," available at
http://www.cancer.gov/clinicaltrials/developments/doctors-barriers0401 (last accessed August 13, 2007).
2 Ibid.
3 Israel, B., Schulz, A., Parker, E., and Becker A., "Review of community-based research: Assessing
partnership approaches to improve public health," Annual Review of Public Health 19 (1998): 173-202.
click here to continue review with the next policy stakeholder category
click here to return to the Interactive Review homepage
|
