On Wednesday, Back to School takes a fresh angle on the second stage, confirmation via postmarket trials, with an article from Martz that argues for viewing the studies as a platform for innovation rather than a box to check to satisfy regulators. Using the trials to create a fuller view of which patients are likely to receive how much benefit would be of huge value to patients, physicians and payers.

Part of that will involve the use of real-world evidence, which Martz digs into in a sister article.

Associate Editor Stephen Hansen explores the ins and outs of EMA’s approach, which involves tandem pathways — conditional approval, a process that carries the requirement for postmarket trials, and exceptional circumstances, a pathway designed for cases where it is either unethical or unreasonable to expect comprehensive data can be obtained.

This is accompanied by an analysis by Hansen of the reasons behind Europe’s growing appetite for conditional approval, and a dive into the data comparing approvals by EMA and FDA, looking at areas of overlap and difference, by Meredith Durkin Wolfe, associate editor of data & analytics.

To view Wednesday's Back to School content, click on the links below:

Moving confirmatory trials to a learning system
Continuing biomarker studies after an accelerated approval would have clear benefits for patients, physicians and payers

A role for RWE in the accelerated approval pathway
⁠Real-world evidence is poised to make its mark on confirmatory trials

Quantifying overlap in FDA and EMA expedited approvals
⁠Though they agree one third of the time, the two agencies often make different decisions on the same data

Fewer obligations, increased uptake of Europe’s conditional approval pathway
⁠More companies seek approval via the expedited route as EMA changes its attitude toward risk

EMA’s approach to expedited approval offers some lessons for FDA
⁠Annual check-ins with EMA promote sponsor discipline, provide validation

Delivering the evidence for accelerated approval: a BioCentury Back to School podcast
How postmarket trials to support accelerated approval could become launchpad for innovation