Maurie Markman, MD
Historically, FDA approvals of oncologic agents have occurred as a result of positive phase III trial results. However, Maurie Markman, MD, proposes that in this era of precision medicine, phase III trials with the endpoint of overall survival (OS) should not be the be-all and end-all in respect to drug approvals—particularly in ovarian cancer.
, Markman discussed the need to change the paradigm of clinical trials and FDA approvals for ovarian cancer.
OncLive: Can you discuss your presentation on the treatment paradigm of ovarian cancer?
My talk at this meeting was to basically challenge the existing paradigm in clinical trials in the United States and worldwide in ovarian cancer. There has been so much progress with new drugs and new strategies, and as a result, phase III randomized trials looking at OS as a primary endpoint is simply no longer rational.
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