Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn about a recent paper by Avi Cherla et al. published in on JAMA Network:
“Do we have full transparency in publications and guidelines around newly approved cancer drugs? A published review from a few days ago in JAMA Network Open highlights critical aspects and points to gaps.
Very informative work by an outstanding multidisciplinary team on reporting of clinical trial uncertainties associated with new oncology drugs by journal publications and clinical guidelines following FDA approvals for 2019-2022 period.
Research was done for 52 cancer drugs (56 trials), where by April 2025, results for 48 drugs (51 trials) was published in journals and included in National Comprehensive Cancer Network (NCCN) guidelines. 94 uncertainties (examples: approval based on a single trial, unvalidated endpoint, no long-term data) were found for 38 drugs.
Disclosure of these was limited, as 53% of journal publications and 47% of NCCN guidelines did not mention any of the identified uncertainties. To note, of the 38 cancer drugs, 37% were recommended in the NCCN guidelines with category 1 highest evidence, 58% were recommended with category 2A evidence, and 5% were not recommended.
Authors pointed out that data indicate not full information accessibility to oncologists since journals and guideline bodies do not consistently require disclosure of key clinical trial uncertainties,’ and ‘journal editors, peer reviewers, and guideline developers lack access to individual participant-level data available to FDA reviewers.’
Indeed, good call for increased transparency from FDA to ‘make its benefit-risk assessments more accessible and user-friendly,’ and mandate full and consistent disclosure by at least guidance documents such as NCCN that are widely used as reference by prescribers.”
Title: Reporting of Clinical Trial Uncertainties With New Cancer Drugs in Journal Publications and Clinical Guidelines
Authors: Avi Cherla, Anita K. Wagner, Olivier J. Wouters, Steven Woloshin, Courtney Davis, Elias Mossialos, Huseyin Naci.
You can read the Full Article in the JAMA Network.
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