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Cancer studies often lack necessary rigor to answer key questions
Date:4/29/2013

DURHAM, N.C. Fueled in part by an inclination to speed new treatments to patients, research studies for cancer therapies tend to be smaller and less robust than for other diseases.

This raises some questions about how cancer therapies will work in practice, according to researchers at Duke Medicine, who published an analysis of nearly 9,000 oncology clinical research studies online April 29, 2013, in the journal JAMA Internal Medicine. The studies they looked at were registered on the ClinicalTrials.gov website from 2007-10.

The analysis is part of the Clinical Trials Transformation Initiative, a public-private partnership founded by the U.S. Food and Drug Administration and Duke University to identify and promote practices to improve clinical research.

"We need to understand the strengths and weaknesses of the clinical studies in oncology," said Bradford Hirsch, M.D., assistant professor of medicine and lead author of the study. "There are a lot of reasons for why cancer studies are different than those for other illnesses cancer is a very grave disease and for a long time there weren't a lot of treatment options. But what we're trying to understand is if those differences justify differences in the clinical research being conducted."

Hirsch and colleagues found that oncology clinical research studies were predominantly small, early phase trials that evaluate a single treatment without comparing it to other therapies. Larger, more rigorous trials randomly assign patients to different treatments, "blinding" both doctors and patients from knowing who received the investigational therapy in an effort to eliminate bias.

This orientation toward less robust design differs significantly from other areas of medicine. The trend is partially explained by the accelerated approval process embrac
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Contact: Sarah Avery
sarah.avery@duke.edu
919-660-1306
Duke University Medical Center
Source:Eurekalert

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