Anavex Life Sciences Corp (AVXL)

[XenaLives]

Another excerpt from the article seems to shed light on the delay are experiencing...

Master protocols can be built on existing trial infrastructure, or by building out a new trial network. But, in either case, the authors say that master protocols require "intensive" pretrial planning and coordination across a large number of stakeholders.

For instance, the Lung Master Protocol (Lung-MAP), which consists of multiple Phase 2 and 3 sub-studies of targeted therapies in advanced squamous non-small-cell lung cancer, involved coordination between the Friends of Cancer Research, multiple drugmakers, FDA, the National Cancer Institute, SWOG Cancer Research and the Foundation for the National Institutes of Health.

The authors also note that master protocols, especially long-running ones, should be capable of adapting to changes in the marketplace over time. During both Lung-MAP and I-SPY 2, an exploratory-phase master protocol that investigates treatments for early-stage, biomarker-defined breast cancer, protocol changes were required after new drugs replaced the standard of care in those studies.

"This occurred in Lung-MAP when [Opdivo] nivolumab was shown to have superiority over docetaxel, the standard of care selected for the biomarker-matched sub-studies," the authors write.

But, while master protocols can be designed to adapt to such changes, they are not without cost, and can lead to a temporary halt in recruitment and require new statistical analysis plans.

http://raps.org/Regulatory-Focus/News/2017/07/07/28050/FDA-Officials-Master-Protocols-Needed-for-Precision-Medicine/