Dario Trapani: Very informative story on how clinical trials have been so far “tolerated” in their design

Dario Trapani shared a post on X about a paper by Vinay Prasad et al. published in BMJ Oncology.

“Recall of ibrutinib and issues with therapeutic approval”

Authors: Colton Lipfert, Myung Sun Kim, Alyson Haslam, Vinay Prasad

“This is a very informative story on how clinical trials have been so far ‘tolerated’ in their design, and why it’s time for a change to avoid actual harm on patients!!

Vinay Prasad and coll on drug development and what’s wrong with BTK, ibrutinib.”

Later, Dario Trapani shared another paper on X by Edward Scheffer Cliff et al. published in Nature Reviews Clinical Oncology, commenting:

“Complicated regulatory decision-making following inconsistent trial results: the issue with ibrutinib for mantle cell lymphoma”

Authors: Edward Scheffer Cliff, Talal Hilal and Aaron Kesselheim

“On the same matter, last year Edward Cliff and Program On Regulation, Therapeutics, And Law opened the debate, anticipating the FDA Oncology decision.”

Dario Trapani is a medical oncologist at the European Institute of Oncology (IEO) and a researcher in the Department of Oncology and Hemato-oncology at the University of Milan. He previously served as a Postdoctoral Researcher at the Dana-Farber Cancer Institute, and is focused on population health research.