The Disconnect Between Clinical Trial and Real-World Populations Holds Back Oncology Care

Randomized controlled trials (RCTs) are the gold standard for regulatory approval. However, cancer trial participants are often not representative of real-world patient populations. As a result, patient outcomes may not mirror those found in trials. In a new article published on OncLive, Maurie Markman, MD, discusses the shortcomings of traditional RCTs and how unrepresentative patient populations hold back therapeutic development.

According to Markman, “A landmark paper published several years ago highlighted the unfortunate but not infrequent relationship between regulatory approval and real-world use of an effective novel antineoplastic agent. Bevacizumab (Avastin), a humanized monoclonal antibody against VGFR, had been approved by the FDA as a component of treatment for several malignancies. Because of the potential negative effects of the agent on the vascular system, initial clinical trials excluded patients with several common comorbidities including history of bleeding, thrombotic disorders, cerebral vascular events, and congestive heart failure.”

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(Source: OncLive, September 29^th, 2022)