Maximizing Understanding in Clinical Trials by Maximizing the Talents of the Contributors
*Charles Knirsch, Pfizer Inc 


The Clinical Trial Development (CTD) traditionally was an interactive process among various functional groups. This interaction tended to be a linear process with members providing input but not working in an iterative collaboration. This approach may have led to a higher than expected failure rate in late stage clinical trials after tremendous investment of financial and human resources. In the past two days one has heard about ECTD, EQDD, Adaptive Designs, and Simulation Modeling. For any of these processes to work, the CTD must be a collaborative effort. The TRIAD- where the corners represent Clinical, Pharmacology, and Statistics represent a team that marries the clinical/biological with quantitative skills. Through this collaborative/cooperative environment there will be a greater probability for clinical trials to supply knowledge which will enhance the quality of medicine.