The FDA has modified and increased expectations around data needed to support accelerated approvals in oncology Unlike prior trends, randomized controlled trials will be the preferred approach to support an application for accelerated approval moving forward the acceptability of single arm trials for accelerated approval will receive significant scrutiny Prolonged duration on the market for … Continued
Despite changes in regulatory expectations, adoption of PROs in early-phase oncology trials remains very low (6%). We recommend inclusion of safety-related PROs, such as PRO-CTCAE, in these studies to supplement traditional safety data. While initial analysis can be qualitative, as development proceeds, exposure-response analyses with PROs and/or statistical approaches could be considered to aid dose … Continued
Real-World Application of Physiologically Based Pharmacokinetic Modeling (PBPK) in Support of Decision-Making During Drug Discovery; Guidance and Recommendations for the Utility of PBPK Impact on Candidate Selection and Human Pharmacokinetic Prediction Through Case Examples
