Summary (continued)
Discussion
Research Quality
Since the enactment of the National Institutes of Health
(NIH) Revitalization Act in 1993,67 cancer researchers have put
increased emphasis on recruitment of underrepresented
populations to clinical trials. However, this aspect of the human
research enterprise has received attention primarily in the
secondary analysis of ongoing clinical trials, rather than as an
area of focused scholarship. This reality is clearly reflected in the
quality of studies available for this evidence report. One of the
positive aspects of the studies available for our review is that
they have described a number of barriers and promoters of
participation in clinical trials. However, most of the evidence is
not based on rigorous studies, and a large proportion of the
available studies were not driven by any clear hypotheses. A
major weakness of the available evidence is the limited number
of studies that compared two or more interventions, especially
randomized controlled trials. The quality of the evidence
summarized raises some questions about its adequacy to answer
our questions regarding barriers and promoters of participation
in cancer clinical trials. However, because of the consistency
and patterns of occurrence of the identified barriers and
promoters, it does provide important insights into future
research directions.
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Recommendations and Future Research
Key Questions 1 and 2
- Much of the available body of evidence was developed as
"evidence by convenience" in the context of recruitment
difficulties, or in retrospective analyses of recruitment of
underrepresented populations across multiple clinical
trials. There is a need for well-designed, controlled studies
of strategies to improve accrual to cancer prevention and
treatment trials. These studies should be hypothesis-driven,
and include defined measures of success. They
should also meet the usual standards of the NIH peer
review process.
- Investigators should give careful thought to success
measures for recruitment of underrepresented populations,
and they should avoid setting such measures arbitrarily.
Additionally, researchers should evaluate and report
recruitment results for underrepresented groups more
consistently.
- More attention should be focused on issues of trial design.
If studies are not designed to address problems that are
relevant to patients in underserved communities, then
even the best recruitment strategies will be ineffective.
Similarly, trials that exclude patients with chronic
conditions will preferentially exclude the elderly, members
of minority groups, and patients with lower
socioeconomic status, because they are more likely to have
chronic conditions. Hence, recruitment efforts must
proceed hand-in-hand with initiatives to design relevant
and pragmatic trials.68
Key Questions 3, 4, 5, and 6
- Because of many underrepresented populations' mistrust
of researchers and of research institutions, research efforts
to improve participation of underserved populations in
cancer clinical trials should be developed within the
framework of community-based participatory research,
with community involvement through all phases of the
research.
- The need remains for community-based studies to
understand barriers to accrual in the community,
including attitudes toward clinical trial participation.
Whenever possible, such studies should be linked to the
implementation of cancer clinical trials, and include actual
recruitment as a major outcome. For example, several
studies have suggested culturally relevant education as a
strategy for improving accrual to cancer clinical trials.
There is a need to further investigate the efficacy of
culturally relevant education as a strategy to improve
accrual to cancer prevention trials and cancer treatment
trials.
- There is an urgent need to understand why participation
of the Asian American/Pacific Islander and American
Indian/Alaska Native populations in cancer clinical trials is
minimal to non-existent. Studies of barriers and promoters
of their participation should be linked to opportunities to
participate. New research initiatives in this area may
require several years before they are fruitful in terms of
trial enrollment results.
- Similarly, there is a continuing need to better understand
and improve upon strategies for recruitment of African-American males and Latinos/Hispanics into cancer clinical
trials. Ideally, such studies should include documentation
of existing barriers within a population as a basis for
tailored interventions across the spectrum of barriers and
promoters, including awareness, opportunity and
decisionmaking.
- There is a need for further investigation of effective
communication strategies, including investigations on the
best approach to deliver information about clinical trials,
both at the community level and at the point of
interaction with the potential participant.
- In communities lacking established efforts to promote
awareness about clinical trials, sufficient time should be
allowed for relationships to be built with community
members, including community-based providers, before
accrual can begin. The period for building such
relationships may take several years, but it would vary
depending on the community and the existing
relationships prior to an intervention.
- Some interventions (e.g., media-based strategy for
Hispanic women) have been shown to be effective in
increasing accrual to clinical trials. Such interventions
should be replicated, and where appropriate, the results
should be disseminated widely.
- To advance the evidence regarding efficacious strategies for
improving enrollment to cancer clinical trials, intervention
studies will need to be linked to one or more clinical trials,
depending on sample size requirements. The studies
should include collection of baseline information
regarding prevalent risk factors in the study population.
Systematic data collection about barriers and promoters of
trial participation should be linked to concrete plans for
designing interventions to address such barriers. Moreover,
the next generation of studies of barriers and promoters of
accrual should be multidisciplinary, including the
involvement of community-based participatory
researchers, social and behavioral scientists, as well as
health economists.
- There are many barriers to care, and it is unlikely that
piecemeal strategies to address these barriers will be
effective to promote participation in cancer clinical trials.
There is a need for a cost-effective strategy to address
barriers to care on multiple levels, and in a manner that
can be integrated into the context of the health care
system and of the research team. To facilitate the
integration of recruitment interventions into health care
systems, especially the research team, a study should
compare the efficacy of a recruitment intervention
specialist to that of usual, opportunistic recruitment
practices. The recruitment intervention specialist would be
a professional or paraprofessional staff member who is
appropriately trained to promote awareness about clinical
trials in the community and to help patients overcome
barriers to opportunity. Ideally, the recruitment
intervention specialist would be indigenous to, or at least
have extensive familiarity with, the community targeted by
the recruitment effort. Thus, this role would be analogous
to that of a patient navigator for clinical trials, and its
cost-effectiveness should be investigated.
- Research to improve enrollment of underrepresented
populations in cancer clinical trials must interface with
other ongoing initiatives designed to address cancer health
disparities through discovery, development, and delivery.
Such efforts must overcome the critical disconnect
between discovery and development on the one hand, and
delivery of cancer care on the other.
- Substantial resources will need to be dedicated to research
efforts to build upon the existing evidence on strategies for
improving enrollment of underrepresented populations in
cancer clinical trials. Many of the initiatives that
contributed to the available evidence were probably not
funded. NCI should dedicate adequate funds for well-designed
studies of barriers and promoters of accrual to
cancer clinical trials.
Further investigation is needed on barriers to recruitment of
all of the underrepresented populations, as defined in this
report, into cancer-related clinical trials. The specific
populations are: African Americans (especially men), Hispanics,
American Indians/Alaska Natives, Asian and Pacific Islanders,
adolescents, the elderly, and rural populations. Future studies
should include the evaluation of culturally tailored strategies to
promote awareness about cancer clinical trials among
underrepresented populations. Different types of intervention
approaches should be considered to promote accrual to cancer
therapeutic trials and cancer prevention trials. Research and
evaluation of recruitment strategies may yield stronger evidence
about ways to improve participation of underrepresented
populations in cancer clinical trials. The principal need is for
hypothesis-driven research, and ultimately randomized
controlled trials, to evaluate the most promising strategies for
recruiting underrepresented populations into cancer treatment
and prevention trials.
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Availability of Full Report
The full evidence report from which this summary was taken
was prepared for the Agency for Healthcare Research and
Quality (AHRQ) by the Johns Hopkins University Evidence-based
Practice Center, under Contract No. 290-02-0018. Printed
copies may be obtained free of charge from the AHRQ
Publications Clearinghouse by calling 800-358-9295.
Requesters should ask for Evidence Report/Technology
Assessment No. 122, Knowledge and Access to Information on
Recruitment of Underrepresented Populations to Cancer Clinical
Trials.
The Evidence Report is also online on the National Library of Medicine Bookshelf, or can be downloaded as a PDF File (1.1 MB). PDF Help.
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AHRQ Publication Number 05-E019-1
Current as of June 2005
Internet Citation:
Knowledge and Access to Information on Recruitment of Underrepresented Populations to Cancer Clinical Trials. Summary, Evidence Report/Technology Assessment: Number 122. AHRQ Publication Number 05-E019-1, June 2005. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/epcsums/recruitsum.htm