Timothée Olivier: How Often Do RCTs Compare Next-in-Class vs First-in-Class Drugs?
Timothée Olivier, Medical Oncologist and Attending Physician at the Oncology Division of Geneva University Hospital in Switzerland, shared a post on LinkedIn about a paper he co-authored with colleagues published in JAMA Internal Medicine:
“Our new article is published in JAMA Internal Medicine!
‘Me-too’ or ‘next-in-class’ compounds are drugs with similar mechanisms of action. While some advantages, such as better efficacy or tolerance, can be proposed, these advantages may remain theoretical without direct comparative evidence.
Our research question was simple: how often randomized clinical trials (RCTs) compare next-in-class and first-in-class drugs?
Out of 332 FDA approvals between 2009 and 2020, we included 94 approvals of a next-in-class compound. We found that 27 trials had a randomized trial with an in-class counterpart, but only 6 trials (6%) ultimately demonstrated a survival advantage.
Our conclusion: ‘This is particularly important given that me-too drugs have not led to price competition in oncology (…). Although not always possible (…), future regulatory frameworks should consider mandating head-to-head trials against existing in-class agents whenever feasible.’
Explore our work and results with a free link here.
Thanks to my co-authors!”
Title: Oncology “Me-Too” Drugs Compared With Original Drugs in Randomized Clinical Trials
Authors: Timothée Olivier, Calvin Smith, Vinay Prasad, Ghulam Rehman Mohyuddin
You can read the Full Article in JAMA Internal Medicine.
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