Analysis Says Many Clinical Trials Are Small, Have Quality Issues.

Reuters (5/2, Pittman) reports that an analysis published May 2 in the Journal of the American Medical Association indicates that many clinical trials testing medications and devices are small and the quality is not consistent.

MedPage Today (5/2, Smith) reports that investigators analyzed “the more than 95,000 studies registered since 2004” in the ClinicalTrials.gov database. The researchers found “that the database is dominated by small studies, many conducted at a single center, with significant differences that would make them hard to compare.” The investigators, “for much of the analysis…concentrated on interventional trials in three areas — oncology, cardiology, and mental illness — that included a total of 79,413 studies.”

HealthDay (5/2, Dotinga) reports that altogether, “seven percent of the studies didn’t bother to mention their purpose, while others failed to provide other important details.” The researchers found that “62 percent of the trials from 2007-2010 were small, with 100 or fewer participants.” Just “four percent had more than 1,000 participants.”

Medscape (5/2, Brown) reports, “Mental health trials were more likely than cardiovascular and oncology trials to report use of” data monitoring committees. The researchers found that “oncology trials were least likely to use randomization (64.7% didn’t use randomization, vs 26.2% for cardiovascular trials and 20.8% for mental health trials), and 87.6% of oncology trials were not blinded.”

Related Links:

— “Drug and device trials vary in size, quality: study,”Genevra Pittman , Reuters, May 01, 2012.

Posted in In The News.