Impact of Phase 2b Strategies on Optimization of Drug Development Programs

Selecting the right dose is critical for the success of any drug development program, and for maximizing the value of a product. A well selected dose will have a better chance to demonstrate a desirable risk/benefit profile and thus increase the chance of regulatory success and reimbursement by payors. It will also result in improved patient care and greater benefit to society. Multiple papers have been published within industry’s adaptive design working groups, and these are the key findings. Given that dose selection impacts Phase 3 parameters, it should be assessed in a broader context of the whole development program. There isn’t one solution for all possible development scenarios. For every situation one should specify a series of alternative program scenarios and compare them. Study design has a great impact on the value of a product. Dose selection criteria must be consistent with ultimate program objectives. Additionally, targeting the minimum effective dose should be avoided. Adaptive designs perform much better than fixed designs in dose-selection studies. Larger dose-finding studies improve the chance to select the optimal dose, but this should be balanced against higher costs, and longer development time.