martes, 16 de junio de 2020

Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration | Oncology | JAMA Internal Medicine | JAMA Network

Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration | Oncology | JAMA Internal Medicine | JAMA Network

Morning Rounds

Shraddha Chakradhar

Majority of recent cancer drugs approved based on trials with limitations

The majority of cancer drugs approved in recent years are based on trials that have at least one major limitation, according to new research. Scientists evaluated 187 trials used for the approval of 75 cancer drugs between June 2014 and July 2019. Two-thirds of these trials included at least one major limitation — such as not being a randomized trial or not using an appropriate control arm. And of those that were randomized trials, 30% didn't show an overall survival benefit to the patients who received the drug. 

One final note: Yesterday's item on reactions to the Trump administration's rollback of protections used an outdated term to describe the group affected by the new rules. The rules affect transgender individuals. Thanks to those of you who wrote in to point that out, and my apologies

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