The Center for Cancer Systems Pharmacology

The Clinical Evidence and Communication Unit

Publications

Cherla A, Wagner AK, Wouters OJ, Woloshin S, Davis C, Mossialos E, Naci H. Reporting of Clinical Trial Uncertainties With New Cancer Drugs in Journal Publications and Clinical Guidelines. JAMA. 2025 Oct 28;334(16):1480-1482. doi: 10.1001/jama.2025.13917. PMID: 40900610; PMCID: PMC12409641.

Cherla A, Woloshin S, Wagner AK, Wouters OJ, Davis C, Mossialos E, Naci H. New Cancer Drug Approvals: Less Than Half Of Important Clinical Trial Uncertainties Reported By The FDA To Clinicians, 2019-22. Health Aff (Millwood). 2025 Jul;44(7):830-838. doi: 10.1377/hlthaff.2024.01134. PMID: 40623257.

Forrest R, Aggarwal A, Tregear M, et al. Patient Perspectives on Approval Speed vs Evidentiary Certainty in US Cancer Drug Approvals. JAMA Netw Open. 2026;9(6):e2617450. doi:10.1001/jamanetworkopen.2026.17450 

Liu ITT, Bourgeois F. Closing the Evidence Gap for Drugs in Children – Measures to Strengthen the Pediatric Research Equity Act. N Engl J Med. 2026 Apr 23;394(16):1566-1568. doi: 10.1056/NEJMp2518278. Epub 2026 Apr 18. PMID: 42012006.

McGonigle R, Bourgeois FT. Delays in Pediatric Studies Required Under the US Pediatric Research Equity Act. JAMA Netw Open. 2025 Oct 1;8(10):e2541176. doi: 10.1001/jamanetworkopen.2025.4117 . PMID: 41165709; PMCID: PMC12576482.

McGonigle R, Naci H, Siebert M, Ouvina M, Gutiérrez-Sacristán A, Wagner AK, Bourgeois FT. Pediatric studies and labeling additions required by the U.S. FDA for novel drugs approved from 2011 to 2023: A retrospective cohort study. PLoS Med. 2025 Dec 17;22(12):e1004651. doi: 10.1371/journal.pmed.1004651. PMID: 41406177; PMCID: PMC12742784.

Siebert, M, Wallach J, Bourgeois FT. Reporting and Publication of Postmarket Clinical Trials for Novel Drugs Approved by the FDA, 2016–2023. JAMA Netw Open. 2026 Jul 1;9(7):e2624832.

Siebert M, McGonigle R, Gutiérrez-Sacristán A, Naci H, Wagner AK, Bourgeois FT. Completion and outcomes of postmarketing requirements and commitments issued by the US Food and Drug Administration for new drugs, 2016-24: cross sectional evaluation of postmarketing studies. BMJ Medicine. 2026;5:e002307. 

Shahzad M, Dubois S, Costa R, Argetsinger S, Ross-Degnan D, Bourgeois FT, Wagner AK. Assessment of Oral Anticancer Medicines in Pediatric Patients before the Research to Accelerate Cures and Equity (RACE) Act, 2007-2021. J Pediatr 2026 Mar:290:114949. doi: 10.1016/j.jpeds.2025.114949. 

Shahzad M, Elsallab M, Siebert M, Bourgeois FT. Assessment of United States Food and Drug Administration Approval of Cell and Gene Therapies. Clin Pharmacol Ther. 2026 Jul 21:10.1002/cpt.70396. doi: 10.1002/cpt.70396. Epub ahead of print. PMID: 42482162; PMCID: PMC13388474.

Wang IV, Davis C, Forrest R, Cherla A, Siebert M, Cowden J, Walker S, Krishnamurti T, Bourgeois FT, Woloshin S, Wagner AK, Naci H. Navigating the Prescription Drug Information System. Clin Pharmacol Ther. 2026 Jul 25:10.1002/cpt.70401. doi: 10.1002/cpt.70401. Epub ahead of print. PMID: 42502239; PMCID: PMC13401667.

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