Date Posted: November 5, 2009
Christine Clemson, PhD describes her thesis project: The goal of my thesis project was to more fully understand the process of introducing a new therapy for a human disease. Working with Dr. Shalesh Kaushal in the Department of Ophthalmology, I designed a Phase II, multi-site, randomized placebo controlled trial to test the efficacy of Valproic Acid for patients with Retinitis Pigmentosa, a serious blinding disease. I experienced and learned (and annotated for the institution) the entire process from IRB submissions to a successful IND application to the FDA. In working on this project, I considered and fully developed multiple study designs, performed a variety of data abstraction activities, and carried out and completed an analysis of pilot data that served as the basis for the power calculations for the proposed trial. I developed the protocols, case report forms, consent forms, and other materials necessary for these submissions. I produced two clinical manuscripts during this period and developed contacts at the FDA and pharmaceutical companies. I am currently developing, with the business systems group at the UMMS, the first in-house clinical trial data management tool. I also performed an "informal" audit of the core capabilities of our institution for investigator initiated clinical studies.