Adaptive Trial Designs
Adaptive designs carry high expectations of delivering more efficient and effective drug development decision making. However, these designs can sometimes be technically very complex and confusing to the non-statistician. Consequently they require experienced handling, especially if employed in late stage development and decision making. KJC Statistics has hands-on experience of practical adaptive trial design including successful interactions with FDA and other regulatory authorities on their use in supporting drug approval and labelling. KJC Statistics can help de-mystify adaptive designs and construct the best adaptive design relative to your development goals and budget.
Efficient Phase II Trial Design For Decision Making
Phase II results are critical in the decision to proceed, or not, to further large scale Phase III investment. A key focus of Phase II design and planning should therefore be effective decision making. KJC Statistics can help guide you toward efficient Phase II designs for critical decision making design.