Effective Drug Supply for Adaptive Clinical Trials: Recommendations by the DIA Adaptive Design Scientific Working Group Drug Supply Subteam

摘要

During the past decade, there has been increasing interest in adaptive clinical trials in pharmaceutical drug development as a means to improved decision making, better dose selection, and reduction in cost and time to market. Nevertheless, the operational challenge of drug supply continues to be a barrier preventing greater uptake of adaptive designs. Such studies require the ability to quickly accommodate changes in treatment allocation while maintaining the integrity of the blind. The DIA Adaptive Design Scientific Working Group formed a subteam to discuss solutions to the drug supply dilemma. In this paper, the subteam discusses effective strategies for drug manufacturing, labeling, packaging, and randomization and addresses financial concerns.