The discussion leaders of the concurrent breakout sessions reported on their discussions.

Session One | Session Two | Session Three

Session I: After the Clinical Trial-Then What?

Dr. Limacher listed four themes that emerged from the breakout session:

1. Be prepared for the end at the beginning. Plan for two scenarios-a timely, planned closeout and an untimely, early closeout. Likewise, the clinical trial personnel should facilitate transitions from the research setting, particularly if the research participant depends on the clinic setting for other forms of clinical care, so that he or she can transition back to the provider or on to a new clinical provider early in the study. That planning should be part of both the proposal and the protocol.

2. Involve participants in planning for the closeout, communicate how and when the study results will be revealed to them, and follow through with the plan. The involved providers should be updated regularly about the activities of the trial and should be informed about the outcome of the study. Community partners should be fully involved as well. Likewise, individuals who are screened out at the beginning should be involved in networking for future studies.

3. Distinguish research from clinical care while recognizing that overlap exists, particularly when the research study is the only current care provider. Researchers must consider the possibility that care is an incentive for participation. Other care provisions should be planned from the beginning of the study.

4. Require participants to have a primary care provider. The research community should support efforts that will ensure health care for all Americans.

Session II: Minority Investigators in Clinical Trials-How Important Are They?

Dr. Evans reported on several themes that emerged from the breakout session:

1. Acknowledge the need to increase the number of minority investigators and the difficulty in recruiting these individuals. Minority investigators are critical for successful recruitment of diverse participants, especially for training nonminority researchers in appropriate methods to increase diversity in clinical trial studies. The relationship between minority and nonminority researchers must be transformed.

2. Design studies statistically powered to answer gender and racial/ethnic research questions.

3. Recognize the role of minority and community-based health care providers as important partners and co-investigators.

4. Encourage nonminority investigators to find ways to improve participation rates among diverse segments of the population through (1) training more minority nurses and nurse practitioners as well as study staff who are culturally proficient, (2) volunteering at medical service clinics in relevant communities, (3) building a research infrastructure that is both ethnically diverse and diverse in terms of professional training, and (4) seeking mentors who are successful minority investigators or successful in recruiting diverse cohorts to trials.

5. Support the idea that partnerships between community institutions and universities can help accomplish recruitment goals.

6. Establish the long-term benefit for participants in terms of drugs, access to care, and health information.

7. Recognize the significant disparity in research resources in rural versus urban areas.

8. Recognize the ability of minority investigators to incorporate humanistic and spiritual values in the research infrastructure and in health care.

9. Develop appropriate incentives for nonminority investigators to include minority participants in trials.

10. Design research studies with specific goals and benefits that appeal to diverse cohorts.

11. Uphold cultural proficiency as an important factor in clinical research.

12. Ask if there is a role for partnership of NIH clinical trials infrastructure and AHRQ to provide program enhancements for research aimed at increasing participation rates.

13. Continue to challenge the validity of data not obtained from a diverse population cohort.

Session III: Role of the Community Advisory Board and Outreach Activities

Mr. Murguia explained that the breakout session involved a discussion of the role that community advisory boards play from both a community and a principal investigator perspective. The session included the following topics:

1. The advisory function of the community advisory board
2. What community advisory boards can and cannot do
3. The components of a successful community advisory board
4. Ensuring parity, inclusion, and representation on a community advisory board
5. The location and timing of meetings, creating a sense of ownership on the part of board members for the work they do in the community, ensuring dialogue within the community and between the site and the community advisory board, and strong principal investigator involvement

Ms. Madey reviewed the breakout session's emphasis on the importance of defining community from the point of view of the goal and purpose of the research.