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Analysis finds clinical trials often small, of poor quality - HD Home Cinema Projectors by akjxue@sina.com akjxue





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Analysis finds clinical trials often small, of poor quality - HD Home Cinema Projectors by
Article Posted: 10/20/2013
Article Views: 251
Articles Written: 2010
Word Count: 638
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Analysis finds clinical trials often small, of poor quality - HD Home Cinema Projectors


 
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Database offers big picture of medical research in United States. By Randy Dotinga HealthDay Reporter TUESDAY, May 1 (HealthDay News) -- A new analysis of registeredU.S. clinical trials -- the research that seeks to determine ifmedical treatments and prevention strategies work -- finds thatmany are small and of poor quality. Studies of cancer treatments, in particular, often fail to followthe highest standards of medical research, the analysis found.Meanwhile, a full 7 percent of the studies didn't bother to mentiontheir purpose, while others failed to provide other importantdetails. "We think expert groups need to start scrutinizing the databasemore and really examine the quality of the trials one by one," saidreport author Dr.

Robert Califf, vice chancellor for clinical andtranslational research at Duke University. "For the first time, wehave 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 lawin the United States, many kinds of studies must be registered inthis database. As the law has been strengthened, the number of registered trialshas grown.

A total of 40,970 trials were registered between October2007 and September 2010, compared to 28,881 trials registered overthe previous three years. "In the past, there would be a lot of studies done, but many wouldnever be studied or reported anywhere," Califf explained."Sometimes you'd only see the ones that were positive. Now, we havemuch more accurate information." However, the analysis found that most clinical research in thedatabase isn't very extensive, raising questions about reliability. The new report says 62 percent of the trials from 2007-2010 weresmall, with 100 or fewer participants.

Only 4 percent had more than1,000 participants. "There are 330 new clinical trials being registered every week, anda number of them are very small and probably not as high quality asthey could be," Califf said. Ideally, medical studies compare randomly chosen groups of peopleto each other, with one group getting a treatment and the othergetting another treatment or an inactive placebo. However, 65percent of cancer studies didn't randomize their participants,compared to 26 percent of cardiovascular studies.

The finding raises questions about whether cancer studies should bedone differently, Califf said. One expert agreed that the quality of medical research in theUnited States is lacking. It's clear that "a lot of studies are of poor quality," said KayDickersin, director of the Center for Clinical Trials at JohnsHopkins Bloomberg School of Public Health in Baltimore andco-author of an editorial accompanying the report. That's a problem because the medical world relies on research notonly to determine whether new medications work but also to figureout guidelines for common medical procedures, such as whetherpeople should get colonoscopies, Dickersin said.

Dickersin noted that the federal database includes incompleteinformation about some studies. For example, 7 percent of studiesregistered from 2007-2010 didn't mention their purpose, as isrequired; 4 percent didn't say how many volunteers would take part. The lack of correct data slows down researchers who are trying toanalyze a swath of research for studies known as meta-analyses thathelp doctors figure out guidelines, Dickersin explained. The report appears in the May 2 issue of the Journal of the American Medical Association.

More information The U.S. National Library of Medicine has a fact sheet about clinicaltrials.gov. SOURCES: Robert Califf, M.D., vice chancellor, clinical andtranslational research, Duke University, Durham, N.C.; KayDickersin, Ph.D., professor and director, Center for ClinicalTrials, and director, U.S. Cochrane Center, Johns Hopkins BloombergSchool of Public Health, Baltimore; May 2, 2012, Journal of the American Medical Association Copyright © 2012 HealthDay.

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