Research Shows Most Clinical Trials are Too Small and Missing Data

May 4, 2012
Kayda Norman

Applied Clinical Trials

New research released has indicated that the majority of clinical trials are small and missing significant data. This has come to light after analyzing over 95,000 trials registered on ClinicalTrials.gov, despite the 2004 mandate that all published clinical studies must be registered on the online database.

Some studies (7%) even failed to mention the trial’s purpose, and 4% didn’t state how man volunteers were taking part in the study. Those that did give volunteer numbers showed that 62% of trials from 2007 to 2010 had 100 or fewer participants. Nevertheless, the number of registered studies has increased (due to the new law in 2004) with 40,970 studies registered from October 2007 to September 2010 vs. 28,881 from 2004-2007.

Of the trials analyzed, three specific areas were focused on including oncology, cardiology, and mental illness (totaling 79,413 studies). Cancer trials in particular were shown to be the least stringent in following medical guidelines. For example, 65% of oncology trials failed to randomize patients.

"We think expert groups need to start scrutinizing the database more and really examine the quality of the trials one by one," report author Robert Califf, MD, Vice Chancellor for Clinical and Translational Research at Duke University, told healthday.com. "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."

Do you agree with the results of this study? How can companies improve clinical research?

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