Development of a Multi-Site Phase II Clinical Trial of Valproic Acid for Retinitis Pigmentosa

ion of pilot data on Visual Field measures and statistical analysis for study design February -April, 2009 Institutional Regulatory Requirements Dr. Clemson communicates with Brian O‟Sullivan, MD chair of University of Massachusetts Medical Center IRB to discuss specifics of clinical trial February, 2009 Drs. Kaushal and Clemson submit full proposal to UMMMC IRB June, 2009 IRB Approval of Phase II Clinical Trial August, 2009 Data, Safety and Monitoring Board Convened December, 2009 CDER/FDA Interactions Pre-IND teleconferences with Wiley Chambers, M.D., deputy January, February, March and April, May, June, 2009