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pchp.press.jhu.edu © 2010 The Johns Hopkins University Press

Policy and Practice

Applying Community-Based Participatory Research Principles and Approaches in Clinical Trials: Forging a New Model for Cancer Clinical Research

Sarena D. Seifer, MS, MD1, Margo Michaels, MPH2, and Stacy Collins, MSW2

(1) Community-Campus Partnerships for Health; (2) Education Network Access to Advance Clinical Trials

Submitted 17 July 2009, revised 21 October 2009, accepted 24 November 2009. The Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy initiative was supported by conference grant R13-HS016471 from the Agency for Healthcare Research and Quality, with co-funding from the National Cancer Institute. Additional support was provided by the Lance Armstrong Foundation, American Society of Clinical Oncology, California Breast Cancer Research Program, and Intercultural Cancer Council; unrestricted educational funds from Genentech and GlaxoSmithKline provided additional support for the initiative.

The Problem

Although an estimated 20% of adult cancer patients are medically eligible for a CCT,2 adult trial participation in the United States remains under 3%.3–5 Accrual

rates are even lower among ethnic and racial minorities and the medically underserved,6–8 who tend to have higher cancer mortality rates than the population as a whole.9 Ethnic and racial minorities with cancer are also more likely to receive

Abstract

Although an estimated 20% of adult cancer patients are medically eligible for a cancer treatment clinical trial (CCT),1 adult trial participation in the U.S. remains under 3%.2–4 Participation rates are even lower among ethnic and racial minorities and the medically underserved, who tend to have higher cancer mortality rates than the population as a whole.5–7 Given persistent cancer health disparities in these populations, cancer clinical trial participation is increasingly an issue of social justice. Community-based participatory research (CBPR) approaches have been repeatedly recom-mended as a key strategy for increasing and diversifying cancer clinical trial participation and enhancing their relevance and quality. In 2006, Community–Campus Partnership for Health (CCPH) and the Education Network to Advance Cancer Clinical Trials (ENACCT) received funding from the Agency for Healthcare Research and Quality and the National Cancer Institute (NCI), along with industry and nonprofit partners, to develop the first set of national recommendations to employ CBPR approaches in multisite, phase III cancer clinical trials. The Communities

as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy final report, developed through a national advisory committee, two stakeholder meetings and a public vetting process, makes more than fifty detailed recom men-da tions to engage communities in specific and meaningful ways throughout the cancer clinical trial process.1 The report is the first to provide specific guidance as to how and why clinical trials should involve communities affected by cancer—from trial design to implementation to dissemination of results. This paper describes the background and rationale for the initiative, the process used to develop and disseminate the report, and the challenges and opportunities for implementing the report’s community-based approaches to cancer clinical research.

KeywordsClinical research, community-based participatory research, minority recruitment and retention, clinical trials, patient advocate, community advisory board, community-engaged research

either no treatment or treatment that does not meet currently accepted standards of care.10–16

The low accrual rate in CCTs has a significant effect on both the quality of research and the rate at which new scientific discoveries are made.17,18 Better representation of all those affected by cancer—including different races, ethnicities, age groups and income levels—is critical to producing more generalizable findings to the population as a whole.8,19–22 Slow or insufficient patient enrollment in clinical trials significantly

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hampers trial completion and frequently results in the early closure of clinical trials. In a recent preliminary analysis of phase III CCTs led by two national cooperative groups, 15% to 30% of trials were closed owing to poor accrual (Dilts D, personal correspondence, February 2, 2008).

The low accrual rate in CCTs—especially among eth-nic and racial minorities, older adults and other medically underserved groups—is a matter of social justice.6 Indeed, the principles of social justice, as articulated in the Belmont report on research involving human subjects,22 demand better representation of all populations in CCTs to ensure the just distribution of the benefits and burdens of research participa-tion.20 A number of reports have observed that enhancing trial participation can address persistent disparities in cancer incidence, morbidity, and mortality.23,24

The literature has identified numerous barriers that nega-tively affect participation in cancer clinical research.25 Experts have repeatedly noted that to both overcome these barriers and develop successful approaches to recruitment, such efforts must (1) identify effective strategies to build trust between researchers, patients and the broader community26; (2) change both the local environment and the behaviors of clinical

research staff in which studies are implemented, to increase minority access to research participation27; and (3) address persistent barriers to CCTs through the use of CBPR.26

Premise And Promise for CommuniTy engAgemenT in CCT design And imPlemenTATion

Central to many successful initiatives that seek to under-stand and improve the health of communities—in particular, ethnic and racial minorities and low-income people—are participatory research models in which communities are actively engaged throughout the research process through partnerships with researchers.28

In 2004, the Agency for Healthcare Research and Quality (AHRQ) issued an evidence report suggesting that CBPR can enhance recruitment and retention of study participants and improve research quality and outcomes.29 The report cited the application of CBPR across a wide range of clinical and behavioral research, including cancer, substance abuse, hyper-tension, heart disease, diabetes, and HIV/AIDS.

Although there are few reported applications of CBPR approaches throughout all aspects of a clinical trial,30,31 a number of groups have implemented community engagement

Figure 1. Community engagement Opportunities at each Stage of Phase iii CCT Design & implementation

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Seifer, Michaels, & Collins Applying CBPR to Clinical Trials

strategies in therapeutic clinical research. Perhaps the best example of comprehensive and systematic implementation of CBPR principles and approaches in clinical research is the National Institute of Allergy and Infectious Diseases–funded HIV/AIDS clinical trials network program that requires the involvement of community members.32

Numerous government-sponsored reports have called for the need to involve community members in clinical research design, implementation, outreach, and accrual3,33–36 to improve clinical research participation, especially among ethnic and racial minorities. Notably, the AHRQ evidence report rec-ommended that future research “to improve participation of underrepresented populations in CCTs . . . be developed within the framework of CBPR, with community involvement through all phases of the research.”26 Despite these repeated calls for action, none of these recommendations have been systemati-cally implemented and are still largely absent from national policy forums37 and efforts to reform the CCT enterprise.38

In 2006, CCPH and the ENACCT sought and received fund-ing from the AHRQ and the NCI to develop a strategic plan for applying CBPR principles and approaches to multi-site, phase III CCTs. The funded initiative, “Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy” envisioned a phase III CCT system that meaningfully engages communities at all points throughout the research process (Figure 1), from national design to local implementation to dissemination. The Lance Armstrong Foundation, American Society of Clinical Oncology, California Breast Cancer Research Program, Intercultural Cancer Council and unrestricted edu-cational funds from Genentech and GlaxoSmithKline provided additional support for the initiative. This paper describes the background and rationale for the initiative, the process used to develop and disseminate the report, and the challenges and opportunities for implementing the report’s community based approaches to cancer clinical research.

develoPing A sTrATegiC PlAn for CbPr APProAChes in PhAse iii CAnCer CliniCAl TriAls

The initiative involved a series of key steps that we briefly describe below.

national Advisory Panel

ENACCT and CCPH established a fourteen-member

National Advisory Committee to guide the initiative, com-posed of national leaders from five key stakeholder groups: (1) cancer clinical research investigators and their staff from both academic and community settings; (2) cancer clinical research sponsors from both government and industry; (3) cancer patient advocates and advocacy organizations; (4) community-based organizations whose constituencies are disproportionately affected by cancer; and (5) experts in CBPR. The committee met monthly by phone for the first 18 months of the initiative.

stakeholder meetings

With the guidance of the National Advisory Committee, ENACCT and CCPH convened in September 2007 a diverse group of seventy people from the above-mentioned key stakeholder groups to develop recommendations for applying CBPR principles and approaches to phase III CCTs.

A background paper articulating the rationale and goals of the project, along with a set of invited commentaries on the paper,39 were shared with participants before the meeting. To ensure a shared understanding of both CCTs and CBPR, orientation sessions on each topic were held. During the meeting, participants discussed the definition of community and who “represents” community, the need for improving community engagement in the CCT process, the pressures faced by cancer researchers and institutions, and how engage-ment works in other clinical research systems. In particular, participants examined the federally funded AIDS Clinical Trials Group, which has an analogous structure to the NCI National Cooperative Groups,40 but has incorporated com-munity engagement and CBPR principles since the late 1980s. At this first of two gatherings, participants articulated a vision for the future and guiding principles for the development of the strategic plan, as described in Table 1.

Participants adopted the definition of “community” advanced by the Centers for Disease Control and Prevention: those whose participation is necessary for the implementation of the research and whose well-being is likely to be affected by the conduct of the research.41 For years, cancer patient advo-cates have been representing the cancer patient “community,” providing critical input into the design and implementation of CCTs at both national and local levels. However, to reap the full benefit of community engagement in phase III CCTs,

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participants recommended that (1) the definition of commu-nity be expanded, such that communities disproportionately affected by cancer morbidity and mortality should also be well-represented (see side bar); (2) there should be a greater number of community representatives, and (3) their roles be systematized, strengthened, and made more inclusive.

drafting and vetting the recommendations

After the first stakeholder meeting, participants joined one of three workgroups—National Level Trial Design and Implementation; Local Level Trial Implementation; or Data

Analysis, Interpretation and Dissemination. The workgroups met via conference call over a 5-month period to develop initial recommendations for research, practice, and policy. The draft recommendations were circulated widely for com-ment through listserv postings, conference presentations, and teleconferences. We received more than fifty comments from Cooperative Group chairs, patient advocates, CBPR and public health researchers, oncologists, research nurses, and staff from the NCI and the AHRQ. With guidance from the National Advisory Committee, the comments were reviewed and the predominant themes were identified. These are sum-marized below and illustrated with a direct quote from the comments received. Supportive comments fell into five main categories:

1. The recommendations have potential to improve the design and conduct of CCTs: “These recommendations . . . [are] useful . . . both to improve the recruitment of study participants and for improving interpretation of study results for different population groups.”

2. Strengthen the role and impact of community/patient representatives: “Most of us have had a research focus that has removed us from spending a lot of time in meetings with communities . . . we then lose that con-nection. To include those advocates whose primary focus is working with communities is critical.”

3. Recruit, prepare, and support community/patient repre sentatives: “The advocates really need to take responsibility for training their new colleagues because they are the only ones who really know how the job is done.”

When considering who best represents the community perspective in phase III CCTs,

participants recommended the inclusion of both community representatives and patient advocates, recognizing that both are essential to the research process:

•Community Representatives have experience with the healthy population at risk and ideally are affiliated with a community-based organization or group whose constituency is disproportionately affected by cancer.

• PatientAdvocates have experience as a patient with cancer, caregiver, or family member and ideally are affiliated with a cancer advocacy organization or group.

Table 1. Stakeholder Meeting Vision for the Future and guiding Principles

Vision for the FutureA Coordinated National-local System That includes Trained Community representatives and Patient Advocates involved in each Component of Phase iii CCTs.

Principles for Developing the Strategic Plan

Focus on improving process and outcome of phase III CCTs

Focus on recommendations that facilitate application of CBPR principles and community engagement strategies

Evaluate recommendations against CBPR principles

Acknowledge the many access barriers to CCTs that are beyond the scope of this project

Acknowledge that federal research priorities impact the plan but are beyond the scope of this project

Acknowledge that we cannot fix all that may be broken about the U.S. health care system

Build upon efforts of those in the CCT system currently working to engage communities

Challenge the CCT system to change, while also working within the system

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4. Change is challenging and time consuming, but ulti-mately worth the effort: “The expectations outlined . . . will be challenging to meet, but the potential advance in individual and community understanding and use of research findings is great.”

5. Test out these ideas: “Several pilots should be conducted.”

Critical comments fell into six main categories:

1. Need strong rationale or evidence base: “You need docu-mented examples of where having communities involved early in the process materially changed the study design, study execution, or, ultimately the accrual rate.”

2. Need to more fully acknowledge existing patient advo-cates/advocate role: “[T]here are patient representatives that have been involved (in cooperative groups) since 1992. . . . I agree that we need a more concerted and focused effort, but to deny that anything has been done doesn’t paint an accurate or fair picture.”

3. Need to pay attention to current realities: “[T]he coop-erative groups are miserably under-funded at present . . . our academic hospitals have to contribute an average of $3,000–$5,000 for every new patient they accrue to a trial.”

4. Concern over unfunded mandates: “The recommen-dations . . . represent a large number of potentially

“unfunded mandates” wherein groups will be required to take certain steps by the NCI without any incremen-tal funding to do so.”

5. Concern over further slowing down trials: “In the end we may improve the diversity of patients on trial, but the results may be years slower in arriving and, if all of the recommendations are funded, we may have even less money to do research.”

6. Concern over misplaced priorities: “If a person in a community is aware of a clinical trial and anxious to enroll, that does them no good if their doctor is not prepared to provide the option.”

Project participants reconvened in March 2008 to revise the recommendations based on the comments received. At the meeting, participants also articulated the potential benefits of a community-engaged CCT system (Table 2).

The revised draft recommendations were again widely circulate for comment and revised before being released in October 2008 as the Communities as Partners final report.1 The report is the first to provide specific guidance as to why and how the CCT process should involve communities affected by cancer—from trial design to implementation to dissemination of results.. The report’s fifty-eight recom-mendations fall into seven major categories (Table 3) and

Table 2. Potential Benefits of a Community-engaged CCT System

CBPr Approaches in Trial Design at the National Level Can Help to:

CBPr Approaches in Trial implementation at the Local Level Can Help to:

CBPr Approaches in the interpretation, Dissemination and implementation of Cancer research Studies Can Help to:

· Ensure well-designed, high quality, cost-effective trials that will accrue, in a timely manner, sufficient numbers of patients and patients from diverse backgrounds

· Ensure that trials are more universally relevant to the real lives of patients

· Increase participation of underrepresented populations in trials

· Enhance community awareness of and trust in clinical research

· Ensure that clinical trials opened for local accrual can more readily accrue patients

· Enhance community comfort with and trust of researchers, research institutions and the research process

· Enhance community understanding about clinical research, enabling them to make more informed decisions about whether to participate in a trial

· Increase the rigor and validity of the research

· Encourage researchers to think of community involvement/engagement as a benefit, not a burden

· Promote the early adoption of safe and effective therapies at the community level

· Increase equitable access to state-of-the-art care and reduce cancer health disparities

· Improve health literacy

· Build greater trust in the clinical trials system

· Build greater public awareness about the importance of CCTs

· Generate stronger participation in CCTs

· Identify issues that should be addressed in phase IV effectiveness studies

· Enhance dissemination of research findings to the public and community clinicians

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target specific key stakeholders in the CCT process, including the NCI, NCI-sponsored National Cooperative Groups, the U.S. Food and Drug Administration, the Office of Human Research Protections, industry, institutional review boards, and local research sites and investigators. In addition to making recommendations, the report also includes extensive appendices that suggest action steps and resources to support their implementation.

disseminATing And imPlemenTing The rePorTThe report dissemination process has involved a two-

pronged approach: outreach to key audiences through conferences and meetings, and support for groups seeking to implement specific recommendations.

outreach to Key Audiences

As the largest provider of publicly funded phase III CCTs, the NCI-sponsored Cooperative Groups were a key dissemi-nation audience. Project staff presented at four Cooperative Group semi-annual meetings.42 Other audiences included institutional review boards, National Institutes of Health Clinical and Translational Science Awardees, NCI staff, and the American Cancer Society health disparities community.43 The AHRQ also invited a presentation on the report at its annual conference as the sole example of nonprofit organiza-tions utilizing its evidence reports as a foundation for a policy change initiative.44

The “implementation Partners” Program

Typically, national reports are released as stand-alone documents with no support provided for their implementa-tion. Industry funding for the project allowed us to release the report with a request for proposals from organizations seeking to implement specific report recommendations. These “implementation partners” would each receive a modest 1-year seed grant, along with training and technical assistance from ENACCT and CCPH. Forty-three organiza-tions submitted proposals, including NCI designated cancer centers, community-based organizations, and community oncology practices from twenty-six states. After a merit review process, these four organizations were selected to participate: Columbia St. Mary’s Health System in Milwaukee, the Grand Rapids Michigan Community Clinical Oncology Program,

the Vanderbilt Ingram Cancer Center, and the UNC Carolina Community Network.45

ENACCT and CCPH are convening the four selected sites for monthly technical assistance conference calls and several have also sought on-site training. All are conducting process evaluations and are leveraging other resources to sustain their work beyond the 1-year period of seed grant funding. The results of these efforts will be reported in a subsequent report.

ChAllenges To imPlemenTing The reCommendATionsThere are a number of challenges to implementing the

report’s recommendations. We have identified the main comments and criticisms that were raised during the vetting of the draft report recommendations. We now highlight the two challenges that have proven to be the most significant throughout this initiative and during the year since the report was released.

mistrust and lack of an organized Constituency to Advocate for Change

Unlike HIV/AIDS research, which has long had an expec-tation of community involvement from both the researcher and patient perspective, the same does not hold true for in cancer clinical research. Although cancer patient advocates have worked for years to gain influence within the CCT research system, they have been few in number, their influ-ence is highly variable, and the mandate for their involvement is weak at best. Some researchers continue to question the need for their role, let alone expanding their ranks to include community representatives.

Seeking to achieve a unified vision among the five distinct constituencies assembled by this project proved challenging, despite several deliberate attempts to orient them to each other’s perspectives and “world views.” A significant portion of the first meeting was spent sharing perspectives on an established clinical research “system” that some participants—especially those from community-based organizations—felt ready to challenge, whereas others—especially those working in the system—were quick to defend. In some cases, groups were skeptical of each others’ motives and capabilities. Some CBPR experts did not view community engagement in CCTs as a high priority and were skeptical that CCTs could truly be

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Table 3. report recommendations for Community engagement in Phase iii CCTs

Category rationaleexample recommendation:

We recommend that . . .

I. Ensuring a Mean ing ful Role for Community Repre sentatives/ Patient Advocates (CR/PAs) in Phase III CCTs

It is critical to broaden community involvement in clinical research through expanded opportunities for both CRs and PAs. However, if they are to be ethically and meaningfully involved in the research process, the system must ensure fairness, transparency, training, clear role definition, and meaningful integration.

Public and private sponsors of Phase III CCTs:(I.1) Ensure that the application and selection process for CR/PAs serving at the national level is open and transparent. Opportunities to serve should be widely communicated both to traditional and non-traditional sources of potential candidates.

II. Ensuring Community Perspectives in the Institutional Review Board (IRB) Review Process

Although phase III CCTs are designed nationally, IRBs play an important role not only in approving the study from an ethical perspective, but also in ensuring locally appropriate consent and recruitment activities. IRBs present an important and often overlooked opportunity for community participation.

IRBs that review Phase III CCTs, including the NCI Central IRB:(II.1) Be comprised of 25% community IRB members who are properly oriented, trained, mentored and compensated by the IRB sponsoring institution.

III. Improving the Informed Consent Process

The complexity of the informed consent process presents a formidable barrier to CCTs. Existing tools—such as the Office of Human Research Protections approved “short form” process and patient navigation – are underutilized in the CCT system. Moreover, approaches to address the needs of non-English speaking, Limited English Proficiency (LEP) and low-literacy individuals in the informed consent process are sorely needed.

IRBs that review Phase III CCTs, including the NCI Central IRB:(III.3) Ensure that all members are trained in approaches to address the needs of minority, low-literacy, poor and elderly, underserved, and LEP populations in the informed consent process.

IV. Ensuring Community Perspectives in Proto col Development, Trial Design and Implementation

Nationally, trained CR/PAs should be actively involved in protocol development and trial design. Locally, CR/PAs can help to ensure that trial selection and patient recruitment/retention are aligned with community needs, capacities and culture.

Public and private sponsors of Phase III CCTs:(IV.2) Encourage and permit funding for local research sites to develop mechanisms, such as community advisory boards (CABs), for ongoing community participation in study implementation.

V. Improving Trial Participant Recruit-ment, Accrual and Retention

Accrual remains an enormous challenge for sponsors and investigators; moreover, substantial uncertainty exists about effective approaches for CCT recruitment, especially among minority populations. Clearly defined recruitment and retention plans, and use of the Culturally and Linguistically Appropriate Services Standards may increase the likelihood of recruitment success.

The National Cancer Institute:(V.10) Expand research funding to document and demonstrate promising practices in CCT recruitment and retention efforts, and in particular, on efforts to involve members of underserved minority, non-English speaking, poor and elderly communities.

VI. Enhancing Local Community Support for Cancer Research

Building trust in the clinical research process increases the likelihood that affected communities are invested in and supportive of the research being done locally. By enhancing community literacy about CCTs, it is possible to change social norms, so that when a person receives a cancer diagnosis, s/he is more likely to inquire about CCTs as an option for treatment.

Local Research Sites implementing phase III CCTs:(VI.4) Engage in outreach activities with community groups, particularly those working to reduce health disparities, to educate the broader community about CCTs beyond any particular trial. Whenever possible, research sites located in the same geographic area should collaborate in these efforts.

VII. Enhancing Community Interpretation, Dissemination and Implementation of Trial Outcomes

Opportunities for community engagement in the final stage of a Phase III CCT include better communication of trial results to participants, as well as broader use of CR/PAs in the interpretation and dissemination of trial outcomes to the broader community.

The National Cancer Institute:(VII.3) Partner with advocacy and community-based groups to set priorities for interpretation, broad dissemination, and implementation of study results, based on importance and applicability. There should be particular emphasis on reaching underserved, minority, LEP, low-literacy, poor and elderly populations.

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participatory in their design. Some researchers and advocates felt that their current efforts to include advocates in the research process were being minimized or criticized. Some patient advocates have questioned the need for broadening their ranks and making their roles more formal. Although many are supporting the resulting vision and recommendations—some enthusiastically—no champions or lead organizations emerged who were willing to make the recommendations a significant advocacy agenda.

A Well-established Cancer research system reluctant or unable to Change

Despite the interest generated by the report (as evidenced by the hundreds of downloads of the report from the project web site and the response to the request for proposals for implementation seed funding) and the ongoing difficulty in recruiting and retaining ethnic and racial minority partici-pants in CCTs, the cancer research community has voiced concerns about the recommendations and their capacity to implement them. Many cancer research institutions lack both the infrastructure and external relationships to begin the journey toward community engagement in clinical research. For example, although all of the organizations applying for implementation seed funding conveyed a sincere desire to implement specific report recommendations, the vast majority were unable to articulate a plan to operationalize community engagement strategies, instead offering to implement tradi-tional patient education and outreach programs. Very few were able to name actual community leaders or community organizations with whom they would partner. Further, most did not consider the broader institutional culture in which community members would need to be supported and engaged.

oPPorTuniTies for imPlemenTing The ProPosed reCommendATions

Despite the challenges, there are a number of paradigm shifts underway at the federal level that could help to acceler-ate implementation of the report’s recommendations. The director of the NCI has commissioned the “Advocates in Research Working Group,” whose mission is to develop rec-ommendations for more consistent integration of advocates across the NCI. The NCI Clinical Trials Working Group is also examining the role of advocates involved in concept and protocol review within NCI scientific review committees. The increased focus at NIH on community engagement in clinical and translational research, most visibly apparent in the NIH Trust Initiative and the Clinical and Translational Science Award program, is contributing to a growing interest in CBPR approaches among academic health centers. The report also aligns with and advances the Obama administration’s agenda more broadly around greater transparency, public engage-ment, and interagency cooperation.

ConClusionFor cancer clinical research to achieve its full potential in

reducing cancer deaths and eliminating cancer disparities, it is imperative to foster greater community involvement in the design and implementation of CCTs. Communities must bet-ter understand how CCTs work, how members can be involved as participants and advisors, and how they can maximally benefit from the results. Similarly, researchers must better understand how communities are organized and function, how community involvement can benefit cancer research, and how to effectively engage communities in meaningful roles. The Communities as Partners report calls for nothing less than a paradigm shift in the way CCTs are conducted.

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43. Presentations: Association for the Accreditation of Human Research Protection Programs (AAHRPP)—February 24, 2009; NCI—May 19, 2009; National Institutes of Health Clinical and Translational Science Awardees—May 14-15, 2009; American Cancer Society – July 28-29, 2009

44. Michaels M, Seifer S. Using evidence-based practice centers reports to promote changes in research, practice and policy: A perspective from two non-governmental organizations. AHRQ Annual Conference. 10 September 2008. Available from: http://www.ahrq.gov/about/annualmtg08/091008slides /Michaels.htm

45. ENACCT and CCPH. 10 February 2009. Four Organizations Selected for National Demonstration Project to Improve Community Engagement in Cancer Clinical Trials. Available from: www.communitiesaspartners.org