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Appendix A Agenda
Pages 84-91

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From page 84...
... JDRF's website continues to be an important tool for referring patients to clinical trials. Navigating the IRB Process The reality of conducting clinical research today is that multicenter trials, with multiple local IRBs, are required to implement a trial capable of providing robust, informative answers.
From page 85...
... During the workshop discussion, Perry Cohen, a Parkinson's patient advocate, noted that his organization, Parkinson Pipeline Project, has developed a research participant bill of rights and responsibilities. The document lays out the features of clinical research that patients desire if they are to participate in a trial.
From page 87...
... clinical research enterprise to answer more than a fraction of them. Drawing on the insights and discussions from the first day of the workshop, day two provided an opportunity for participants to consider current strategies and new approaches for conducting clinical trials in the United States.
From page 88...
... The chapter then turns to the suggestions for improving clinical trials that resulted from the four disease-specific breakout session discussions. Finally, Janet Woodcock's vision for a stable, continuously funded clinical research network in the United States is described.
From page 89...
... In the western United States, the University of Washington works with a number of sites in Idaho, Montana, and Wyoming that do not have medical schools. The IDeA-eligible2 states are funded to create Centers of Biomedical Research Excellence.
From page 90...
... Alving mentioned another Web-based tool, the CTSA Pharmaceutical Assets Portal,4 which links those with an interest in pharmaceutical products to investigators nationwide, as well as at NIH, who want to study the products. Alving listed the six areas in which the CTSA program is focusing significant effort to facilitate improvements in the clinical trial process: • developing data-driven approaches to process improvement; • reviewing steps involved in the initiation of clinical trials; • naming "Champions of Change" at academic health centers -- individuals with the authority to effect changes; • educating academic health centers about uniform templates for clinical trial agreements (CTAs)
From page 91...
... 6 gives research teams • an easy way to collect, disseminate, and protect the privacy of study data. It comprises two secure Web-based applications and provides software and support to partners (CTSA institutions, General Clinical Research Centers, Research Centers in Minor ity Institutions, and other institutions)


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