Patient Disparity in Trials vs Clinic Raises Doubts on Kidney Cancer Drug Efficacy
the ONA take:
Four drugs that were recently approved by the FDA for the treatment of kidney cancer are being doubted for their clinical application based on trial data, according to a recent study published in the Journal of Oncology Practice.
Researchers led by Aaron Mitchell, MD, of the University of North Carolina at Chapel Hill Medical Center, found that with regard to certain cancer drugs, participants in clinical trials are often not representative of patients that ultimately take the drugs.
“We found that patients participating in clinical trials are younger and healthier than many of the patients who are receiving these drugs in the clinical setting,” Mitchell said.
The study compared patients who participated in stage III clinical trials for four kidney cancer drugs with those who received the drugs at both academic and community medical centers.
The researchers found that 39% of the patients who received the drugs would have been considered too sick to participate in the original trials, and therefore would have been excluded.
“If a person will be getting the drug in a clinical setting it is important to know if they can expect to see the same benefits or if they might experience more dangerous side effects,” Mitchell noted.
“Physicians can’t know for sure because the trial data do not directly apply.”
He urged that since current trials are designed by pharmaceutical companies to make them “more expedient,” it may be more realistic to change the perception that FDA approval is the end point for studying a drug efficacy.
Four drugs that were recently approved by the FDA for the treatment of kidney cancer are being doubted for their clinical application.
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