Exploring Challenges, Progress, and New Models for Engaging the Public in the Clinical Research Enterprise Clinical Research Roundtable Workshop Summary (2003) / Chapter Skim
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2. What is Participant-Centered Clinical Research
2. What is Participant-Centered Clinical Research
Pages 9-23
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From page 9... ...
Fran Visco discussed the National Breast Cancer Coalition and its role as an advocacy organization, Kenneth Bertram spoke about the Congressionally Directed Medical Research Programs, and Jennifer Bryson described the partnership between Genentech and breast cancer advocates for the Herceptin trial. Jerome Yates discussed the stakeholder program of the American Cancer Society.
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represents an innovative and valuable corrective to the tendency of conventional clinical research to package intervention methods and programs into one-size-fits-all, off-the-shelf approaches based on a notion of universal best practices." The local, contextual considerations also offer an alternative to centralized regulations for protecting research participants by building trust. According to Dr.
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Chin, the community-based participatory research (CBPR) system would be improved by developing the following: pilot developmental grants; incentives for players to work together; · grant review study sections that understand and value CBPR; and .
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From page 13... ...
One example is the American Cancer Society's "Reach to Recovery" program, in which trained volunteers offer support and comfort to patients before, during, and after breast cancer treatment.7 In the clinical trial setting, the role of the volunteer would be to interpret and explain, but not to expand upon, the directions and orders given by the physician or the nurse to the participant, according to Ms. Tetenbaum.
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Dr. Yates agreed that physician awareness is critical to encourage participant enrollment in clinical trials.
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Given additional information and time with a knowledgeable person, though, that proportion increased to 83 percent. Despite the importance of physician awareness of clinical trials, an NCI survey of primary care physicians recently found that 37 percent said they were not aware of pertinent clinical trials, and 40 percent said they leave the discussion of clinical trials to the patient's oncologist and generally do not continue to follow patients (Crosson et al., 2001~.
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For example, in response to town meetings in places like Marin, California where breast cancer rates are seemingly inexplicably higher than in the rest of the nation and with the help of brainstorming sessions with breast cancer advocacy groups and scientists, NIEHS has decided to create three Breast Cancer and Environment Centers around the country. "The objective of clinical research is to improve the health of the American people, and the American people ought to have an important role in the Development of the research agenda." Jerome Yates In addition, based on discussions with Parkinson's disease advocacy groups over a number of years, NIEHS recently created a consortium center of three institutions to address the environmental aspects of Parkinson's disease.
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From page 17... ...
The Exploration Award supports the initial evaluation of an imaginative concept for which no preliminary datum is available and the Innovator Award encourages creative and visionary breast cancer research. The HBCU/MI (Historically Black Colleges and Universities/Minority Institutions)
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From page 18... ...
The NBCC has developed a set of criteria against which it judges clinical trials to see if they warrant participation of members and to prioritize these trials. Genentech Before 1995, Genentech rarely worked with the patient advocacy community, according to Jennifer Bryson, Director of Corporate Affairs for the company.
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"Advocates can provide meaningful and unique insights that can increase the relevance of the scientific question, the enrollment of clinical research, and the speed of scientific progress," Jennifer Bryson American Cancer Society Jerome Yates, M.D., National Vice President for Research at the American Cancer Society (ACS) , discussed the stakeholder program of the ACS, which involves consumers or patient advocates in the research proposal review process.
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Instead of cooperative groups and cancer centers, the AIDS contingent has its own Research Council made up of consumers, patients, and researchers to develop clinical trials that they then disseminate nationally. Regarding the role of researchers as advocates either on their own behalf or on behalf of research in general Ms.
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ROLE OF INDUSTRY Eighty percent of all funding and activity for clinical trials of medical therapies and medical device intervention comes from industry, and two-thirds of all patients who participate in clinical trials are in industry-sponsored programs (Top AHCs, 2002~. Ken Getz, M.B.A., president of CenterWatch, wanted to know what industry can do to play a part in engaging and educating the public without appearing to be self-serving.
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2001. Primary care physicians' attitudes, knowledge, and practice related to cancer clinical trials.
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From page 23... ...
New England Journal of Medicine 348:721-726. Top AHCs turning away from industry-sponsored clinical trials.
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