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Analysis Finds Clinical Trials Often Small, of Poor Quality
Date:5/2/2012

By Randy Dotinga
HealthDay Reporter

TUESDAY, May 1 (HealthDay News) -- A new analysis of registered U.S. clinical trials -- the research that seeks to determine if medical treatments and prevention strategies work -- finds that many are small and of poor quality.

Studies of cancer treatments, in particular, often fail to follow the highest standards of medical research, the analysis found. Meanwhile, a full 7 percent of the studies didn't bother to mention their purpose, while others failed to provide other important details.

"We think expert groups need to start scrutinizing the database more and really examine the quality of the trials one by one," said report author Dr. Robert Califf, vice chancellor for clinical and translational research at Duke University. "For the first time, we have a chance to look at the entire universe [of clinical research] and we can see that we can do better."

Califf and his colleagues examined the Clinicaltrials.gov database, which includes medical research studies that enroll people. By law in the United States, many kinds of studies must be registered in this database.

As the law has been strengthened, the number of registered trials has grown. A total of 40,970 trials were registered between October 2007 and September 2010, compared to 28,881 trials registered over the previous three years.

"In the past, there would be a lot of studies done, but many would never be studied or reported anywhere," Califf explained. "Sometimes you'd only see the ones that were positive. Now, we have much more accurate information."

However, the analysis found that most clinical research in the database isn't very extensive, raising questions about reliability.

The new report says 62 percent of the trials from 2007-2010 were small, with 100 or fewer participants. Only 4 percent had more than 1,000 participants.

"There are 330 new clinical trials being registered every
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