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Comment & Response
August 26, 2021

Randomized Clinical Trials in the Era of Precision Oncology—The Role of End Points, Industry Funding, and Medical Writing Integrity—Reply

Author Affiliations
  • 1Department of Oncology, Northern Ontario School of Medicine, Thunder Bay, Ontario, Canada
  • 2Department of Oncology, Queen’s University, Kingston, Ontario, Canada
  • 3Department of Public Health Sciences, Queen’s University, Kingston, Ontario, Canada
JAMA Oncol. 2021;7(10):1579-1580. doi:10.1001/jamaoncol.2021.3344

In Reply We are grateful for the comments in response to our study, which describes trends in randomized clinical trials (RCTs) of systemic therapy for breast, colorectal, and non–small cell lung cancer over the past 5 decades.1 Our data show marked uptake in use of (often unvalidated) surrogate end points, industry funding, and medical writers. While some RCTs identify major advances for patients, our overview highlights that among “positive” trials, median gain in overall survival (OS) was modest (3 months). Our increased understanding of the gap between efficacy and effectiveness2 suggests that these gains may be even more modest in routine practice.

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