Stewart Alan Factor - US grants

DESCRIPTION (provided by applicant): Concerns over a crisis in clinical research have been raised for almost two decades. Continuing and increasing problems in this area have adversely impacted the conduct of clinical research, leading to failures in design, recruitment and successful completion of clinical trials. Multiple factors contribute to the existing situation, including scientific, educational, ethical, financial, and regulatory issues. Some of the major problems include: 1) inadequate training in clinical research for many clinicians, scientists, and research coordinators; 2) increasing expectations for the quality of clinical research over the las several decades; 3) greater difficulty in the control of potential confounding factors compared to basic research; 4) increased regulatory requirements related to human assurances and confidentiality of data; 5) increased concerns and regulations related to conflicts of interest, which involve interactions with industry as well as non-industry related personal financial and career advantages; 6) increased complexity in budgetary issues; and 7) difficulties with academic institutions providing efficient support for clinical trials. Conduct of multicenter clinial research trials is even more challenging due to the need for repeated IRB approvals and contract negotiations at multiple institutions. Recently, there has been a call for academic institutions to assert leadership in clinical trials. Without vigorous academic involvement, criticl issues will continue to be unaddressed, important trials will not be conducted, and the public health will suffer. The NINDS has recognized the serious nature of problems limiting conduct of clinical research, and how these problems impair the translation of basic scientific findings to human populations. In an innovative approach to address existing limitations, the NINDS seeks to develop a Network for Excellence in Neuroscience Clinical Trials (NEXT). Emory University Neurology and collaborators in the Atlanta area seek to participate as a Clinical Site in the NEXT clinical research network. Our group has considerable expertise in neuroscience clinical research across a wide array of diseases, drawing from a diverse regional population with an abundance of subjects to address issues for multiple neurological disorders. Emory University provides excellent research resources and will make a strong commitment to the NEXT project, including agreeing to participate as a Tier I site using a central IRB and to implement protocols according to the budgets approved by the NEXT Steering Committee and the NINDS.