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Description:") ") Skip to main content Toggle navigation Home How It Works Training Videos Resources Industry Patient Advisory Committee for Clinical Trials Home PACCT+ began in 2015 as a demonstration project wi
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") ") Skip to main content Toggle navigation Home How It Works Training Videos Resources Industry Patient Advisory Committee for Clinical Trials Home PACCT+ began in 2015 as a demonstration project with funding from PCORI. With that funding, AAMDSIF developed, planned and executed two rounds of patient training in clinical research. Early in the process, a working group with representatives from the bone marrow failure patient community, academic clinical research and industry met regularly to develop the educational protocol for the training sessions. Two training sessions (September 2016 and June 2017) were held to train patients in basic clinical and health services research concepts, with the goal of enabling them to serve on a council to evaluate research proposals. Nearly 40 patients have completed the program, and stand ready to review proposals from academic and industry researchers. PACCT+ members are uniquely positioned to provide feedback to researchers about how research goals can be aligned with patient needs. With the understanding of clinical research processes and procedures, PACCT+ members are able to view each proposal with the researchers’ goals in mind, and provide non-binding suggestions about potential secondary endpoints, and patient consent language. PACCT+ members are able to provide researchers with information on how patients are likely to view the trial in terms of burden and benefit, and offer insight into how to strengthen the proposal, prior to presentation to an IRB, a Scientific Review Committee or the FDA. As we develop this program further, we are eager for comments from both patient and research perspectives as to how best to engage the resources of PACCT+. We are open to a broad range of patient support services to researchers such as: revisions of patient consent forms and other materials to plain language and strategies for recruitment and retention of specific patient populations. Please reach out with suggestions and comments. Search form Search...
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