The PIOs thanked Dr. Lenfant and the NHLBI for convening the fourth annual meeting of PIOs. In questions addressed to Dr. Lenfant, the PIOs focused on ways to foster public understanding of clinical trials and patient participation in these trials.

Encouraging Patients to Participate in Clinical Trials. The participants discussed the possibility of creating public service announcements (PSAs) for television to invite patients to consider clinical trials. Dr. Lenfant noted that experience has revealed two main difficulties with this approach: PSAs often are shown at times of the day when few people are watching television, and patients who are encouraged by a broad invitation to participate are likely to be discouraged and feel rejected if they subsequently do not meet the strict eligibility requirements needed for a particular trial.

Templates for Clinical Research. The PIOs expressed interest in the development of templates for clinical research materials (e.g., consent forms). They were encouraged to peruse the NIH Web site for clinical trials (www.clinicaltrials.gov) to understand the process and issues (e.g., ethics, confidentiality, privacy) that need to be addressed. Dr. Lenfant emphasized the importance of ensuring any such materials fully and accurately describe the risks and benefits of the research in manner that is understandable to patients.

Grantsmanship. The NHLBI offers grantsmanship workshops to help potential applicants for NHLBI grants become familiar with the application and review processes. Preparation of an application is the sole responsibility of each applicant.

Dr. Hedrick announced that the NECA newsletter will include an article about the NHLBI PIO meetings. She invited representatives to send her a list of activities that their organizations have undertaken as a result of the meetings. She, in turn, will provide the information to the NHLBI.

Dr. John Walsh, President and Executive Officer, Alpha-1 Foundation, Miami, Florida, suggested that the PIOs gather examples of clinical research forms (e.g., for consent) to send to the NHLBI for the possible development of template materials. Dr. Lenfant noted that the NHLBI would reflect on the PIOs interest in this activity.

Dr. Lenfant invited the PIOs to give the NHLBI specific guidance on information needed by patient populations regarding participation in clinical trials and research findings that may be ready for a clinical trial. This guidance should be provided to Dr. Carl Roth, Director, Office of Science and Technology, NHLBI, at 301-496-6631 or RothC@nhlbi.nih.gov.

As requested by the PIOs, the NHLBI will consider developing an information product about clinical trials that could be made available to PIOs and local community organizations, including libraries, to educate the public and patients about clinical trials.

Dr. Lenfant thanked all the participants and said that the NHLBI looks forward to next year's annual PIO meeting. The NHLBI will follow up on the actions suggested and will stay in contact with the PIOs.