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

ed by the FDA since 1992 to improve access to treatments for life-threatening diseases such as cancer. As part of that process, early-phase clinical research studies often measure goals other than extending survival.

In addition, drugs marketed for one use and used "off label" for others have less stringent requirements for winning additional regulatory approvals.

"An inherent tension arises between the desire to use new, life-saving treatments and the imperative to develop the evidence that patients, clinicians, regulatory agencies, and advocacy groups need to make sound decisions." Hirsch said. "Unfortunately, the high prevalence of small studies that lack rigor limits the ability to assess the evidence supporting specific treatments."

Hirsch said the analysis also brought to light some disparities between the incidence and mortality of some cancer types, and the volume of clinical research being conducted. For example, lung cancer has the highest incidence, with 14.5 percent of all new diagnoses and 27.6 percent of all cancer deaths in 2010, but was the focus of only 9.2 percent of studies on the register. Meanwhile, lymphoma was the focus of 6.6 percent of studies, while it represents 4.8 percent of cancer cases and 3.8 percent of deaths.

"People who enroll in clinical trials expect their participation to lead to future benefits for patients," said Nancy Roach, chair of the board of directors for Fight Colorectal Cancer. "Small, single-institution trials are not likely to change the standard of care. I see this paper as a call to action to encourage academic institutions to collaborate with each other on more robust trials that may ultimately lead to clinical benefit."


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Contact: Sarah Avery
sarah.avery@duke.edu
919-660-1306
Duke University Medical Center
Source:Eurekalert

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