A successful program to engage the public

The Center for Information & Study on Clinical Research Participation is an independent non-profit organization that opened its doors in March 2004 for the purpose of increasing education and awareness about clinical research participation and increasing recognition of the role that clinical research participants play in advancing medical science. CISCRP’s mission is to:

• Educate, inform and empower patients, the public, medical and research professionals, the media, and policy makers about clinical research participation and what it means to be an active participant in the process;
• Promote greater awareness and understanding of the clinical research process;
• Facilitate more effective collaboration among members of the clinical research enterprise.

CISCRP is not involved in recruiting patients for clinical trials, nor is it involved in conducting clinical trials. Our staff and board of advisors consist of individuals with highly diverse backgrounds from the government, clinical research, healthcare, and advocacy communities.

Since its inception over two years ago, CISCRP has created broad national education and awareness building tools including:

• TV and Radio PSA available in English and Spanish that has had over 80 million viewer impressions. A second TV/Radio PSA is due to be released this winter.
• Print public service announcement in collaboration with the Food & Drug Administration.
• “Education Kits” for reporters who cover clinical research; the kit includes 101 Facts and Figures, Glossary of Terms and Frequently Asked Questions. CISCRP also has developed a list of clinical research participants who are willing to speak with the media.
• Educational brochures in English and Spanish.
• A DVD entitled “Participating in a Clinical Trial” which is the story of two cancer survivors who have taken part in clinical trials.

In addition, CISCRP has conducted several public perception studies to gauge how safe the public feels about participating in a clinical trial. CISCRP has also conducted a survey of 4500 people who use online clinical trial registries. CISCRP was named a subcontractor on the Massachusetts General Hospital’s NIH RO1 grant looking at patient access to health care following participation in clinical trials and if insurance status impacts people’s willingness to participate in a trial.

AWARE for all

Beyond the outreach programs mentioned above, CISCRP has developed a local program that brings awareness building and education into the community and complements our broad national education efforts. Specifically, AWARE for all:

• Consolidates fragmented individual approaches and activities
• Utilizes traditional outreach and advocacy strategies
• Puts a face on the research and health provider communities
• Builds a movement at the local level to complement the national efforts
• Takes awareness building into the heart of the community by outreaching to opinion leaders and organizations in the political, non-profit, healthcare and business arenas.

The program was piloted in Boston in 2005 and 2006 and received rave reviews, with 86 percent of the attendees rating the program as very good or excellent. With the support of national partners, American College of Radiology, PD Trials and PhRMA, CISCRP has been able to expand the program nationwide. AWARE – Indiana was held on October 21, 2006 with Lilly as the lead local sponsor, AWARE – Philadelphia was held on November 4, 2006 and AWARE – Dallas is scheduled for February/March 2007.

AWARE was developed because current outreach and advocacy programs are narrowly focused to be project specific and therefore not designed to provide a general education. They are short-term in their goals and objectives as they are intended to fill individual clinical trials. Once enrollment targets have been reached, these programs are terminated. Their design and implementation also vary from project to project. As such, they fail to provide a far-reaching, consistent and coordinated message.

The lack of high quality information about clinical research and the role of research participants have an adverse effect on the public’s perception of both clinical research participation and clinical research participants. The increase in information and awareness will assist in changing the negative perception.

AWARE for all is open to the public and free of charge. A sample program is below.

Description of specific activities

AWARE for all’s impact goes far beyond the individuals who attend the day long program. The publicity and outreach preceding the program affects tens of thousands of individuals. Activities that expand the impact of the educational message include:

• High-profile Honorary Co-Chairs. High-level public government officials lead the honorary committee because we view this issue as a public health issue. As an example in Boston the AWARE Honorary Committee was co-chaired by Boston Mayor Thomas M. Menino and Massachusetts Lieutenant Governor Kerry Healey; in Indiana the Honorary Co-Chairs were US Senator Richard Lugar, Indianapolis Mayor Bart Peterson and State Health Commissioner Judith A. Monroe; in Philadelphia, the Honorary Co-Chairs were US Senator Arlen Spector and Governor Edward Rendell.
• Creation of an Honorary Committee that consists of opinion leaders in the healthcare, government, business, academic, nonprofit, and advocacy communities. In many cases the people who join the honorary committee were unaware of the issues surrounding clinical research and the invitation to join the committee becomes an educational tool for opinion leaders outside of the health arena.
• Diverse list of organizational partners, including health centers, senior centers, disease specific groups, hospitals, research sites, payors, faith based groups, community groups, professional societies, and advocacy groups. Overall in 2006 the AWARE – Boston, AWARE – Indiana and AWARE – Philadelphia had a total of over 140 organizational partners who helped CISCRP outreach to their respective constituencies through dissemination of brochures, placement of posters in their facilities, articles in newsletters, email notification and other techniques.

Advertising includes a public transportation ad campaign (where possible), newspaper and radio ads, as well as press releases and newspaper articles.

Conclusion

At the conclusion of the program, attendees complete evaluation surveys. Though CISCRP does not rate its success by the number of people who take part in trials, we are asked very often if AWARE attendees are more likely to take part in a trial. For that reason we asked the attendees – after attending AWARE would you be more likely to take part in a clinical trial? In Boston, 57 percent of attendees said they would be more likely to take part in a trial, in Indiana 75 percent said they would be more likely to take part in a trial, and in Philadelphia 75 percent said that they would be more likely to take part in a clinical trial because of their experience with the AWARE for all program.

These statistics clearly make the case that increased education and awareness about clinical research is a very positive step for the clinical research enterprise. Let’s leave you with a quote which we received on an evaluation from the AWARE – Philadelphia program: “I’m really glad I came. Now I’m not afraid to be in a clinical trial because I know what to expect and what kinds of questions to ask.”