When representatives from Biogen and the FDA share the stage ...
Back in November at the STAT Summit in Cambridge, Mass., Biogen’s top scientist Al Sandrock nearly dared FDA regulators not to approve the company’s controversial Alzheimer’s drug. So we were curious if that might come up when Sandrock took the stage alongside the FDA’s drug cop Dr. Janet Woodcock this morning at a regulation conference on the sidelines of JPM.
It did not come up — Biogen’s drug, aducanumab, wasn’t even mentioned during the panel discussion — but Sandrock did use his time on stage to advocate a few intriguing ideas to improve clinical trials. He called for the establishment of “measurement centers” next door to hospitals, which would be staffed with data analysts who would make sure that drug trial data are being collected rigorously and properly.
Sandrock also called for less reliance on the sort of performance tests that are conducted every few months in clinical trials. Performance on those exams can be influenced by so many factors, such as whether patients got a good night’s sleep before taking the test, Sandrock said. Instead, the clinical research community should shift towards measures that come from sensors that can detect how patients are faring in their daily life, he said.
Which led us to muse: It’s a safe bet that we’d be having a different conversation about aducanumab had the patients in Biogen’s controversial trials been wearing sensors.
It did not come up — Biogen’s drug, aducanumab, wasn’t even mentioned during the panel discussion — but Sandrock did use his time on stage to advocate a few intriguing ideas to improve clinical trials. He called for the establishment of “measurement centers” next door to hospitals, which would be staffed with data analysts who would make sure that drug trial data are being collected rigorously and properly.
Sandrock also called for less reliance on the sort of performance tests that are conducted every few months in clinical trials. Performance on those exams can be influenced by so many factors, such as whether patients got a good night’s sleep before taking the test, Sandrock said. Instead, the clinical research community should shift towards measures that come from sensors that can detect how patients are faring in their daily life, he said.
Which led us to muse: It’s a safe bet that we’d be having a different conversation about aducanumab had the patients in Biogen’s controversial trials been wearing sensors.
.png)
No hay comentarios:
Publicar un comentario