Quality assurance in clinical trials

Abstract

Quality assurance is important in the development and conduct of a successful single-site clinical trial. The successful principal investigator (PI) is one who aligns him/ herself with a knowledgeable team with demonstrated capabilities in all aspects of clinical trial design and execution including professionals with expertise in biostatistics and experimental design, research administration including budget preparation and proposal submission, patient recruitment and contact, data collection, data analysis, and computers. The effective PI will become an effective coordinator of these functions by assembling this team, establishing a realistic schedule, and demonstrating enthusiasm, integrity, and leadership. The team, as it is being assembled, and which typically includes nonphysicians, will find helpful an explicitly enlarged, detailed statement of the proposed hypothesis. This statement may include the type of patients to be studied, duration of the proposed observation period, and the methods of evaluation. Careful planning is the best assurance that a successful and worthwhile study will be accomplished.