Public Engagement and Clinical Trials New Models and Disruptive Technologies: Workshop Summary (2012) / Chapter Skim
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4 Models for Public Engagement
4 Models for Public Engagement
Pages 31-38
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From page 31... ...
Susan Love Research Foundation to launch the Love/Avon Army of Women project.2 Because recruiting even 50 volunteers for a clinical trial can be a lengthy process, the Army of Women was conceived as a way to create a large, demographically diverse pool of women interested in participating in breast cancer research, said Marc Hurlbert, Executive Director of the Global Breast Cancer Programs of the Avon Foundation for Women and the Avon Breast Cancer Crusade. By making it easier for researchers to recruit study participants, project managers hoped that more prevention studies will be conducted overall and more will be conducted in women, rather than in mice or in vitro.
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From page 32... ...
and other tests; this request generated responses from 739 women, and the study has already recruited 425; • study looking for biomarkers in breast milk, which needed 250 a lactating women who had been asked by their physician to have a breast biopsy to assess "something suspicious" (a relatively rare occurrence) ; the request generated such a large response that the researchers were able to quickly recruit 334 women, shorten the study's recruitment timeline from 6 months to less than a week, add to the study questions, and expand the recruitment target to 2,000; and • third study needed to recruit 100 Latina women for a study of a breast cancer survivors' quality of life; it received responses from 125 Army of Women volunteers, only 5 of whom were ineligible, enabling the researchers to expand the study 20 percent.
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From page 33... ...
The genetics database enables efficient identification of people with specific genetic profiles. Or, studies can start with a pool of people having a known disease and look for previously unrecognized shared genetic characteristics.
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From page 34... ...
• or a study on hair loss, 23andMe analyzed data from 13,000 cus F tomers; the analysis replicated all known genetic associations, found three novel ones associated with male pattern baldness, and identified a suggestive association that may predict drug response. Administering the survey online was especially helpful, because it could show respondents pictures of different degrees of hair loss, in order to obtain more precise results.
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From page 35... ...
PRESENTATION 9. PUBLISH 20 04 10 20 FIGURE 4-1 A timeline comparing a conventional NIH clinical trial versus the 23andMe research model.
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From page 36... ...
Naughton added that 23andMe has sufficient data to make new genetic associations, as it did for Parkinson's disease, not merely replicate existing studies, depending on the phenotype, and the number of people in the database with a particular condition. RESEARCHMATCH5 Vanderbilt University and its sister CTSA institution, Meharry Medical College, use a number of web-based approaches for patient recruitment, engaging faculty and staff and creating public awareness of clinical studies.
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From page 37... ...
If prospective participants agree to participate, their identity is revealed, and the consent and educational processes proceed as in any other study. As of July 2011, approximately 16,000 people were in the ResearchMatch database.
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