Aiming for excellence -- The target product profile and its uses -- Planning the individual clinical trial -- Distilling the essence of the protocol: the protocol synopsis -- Redistillation: eliminating impurities by carrying out protocol feasibility -- The optimal blend: the approved synopsis and the final protocol -- Of chickens and eggs: the sponsors' dilemma -- Clinician or clinical trialist: the physicians' dilemma -- What about the customer? the patients' dilemma -- About time: making meetings matter -- The brain-scrambling, fit-inducing, mind-numbing technicolor laser show
Summary
Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the proces
Bibliography
Includes bibliographical references (pages 213-215) and index
