“In God we trust; all others please bring your data.” So says a cartoon, displaying an individual being swallowed by a giant wave of paper data. Albert Einstein said, “All our science, measured against reality, is primitive and childlike –and yet it is the most precious thing we have.”
In the world of clinical trials, measuring data and providing care based on the outcomes they produce are the gold standard in medicine. But there have been criticisms about gaps between guidelines-based treatment recommendations and evidence-based data from clinical trials that support those recommendations. Recent studies have shown less than 15 percent of major guideline recommendations are based on high-quality evidence. There have also been debates about funding priorities for clinical research, the design and interpretation of studies, and protections for research participants.
A new study published on May 1 in the Journal of the American Medical Association (JAMA) raises further questions about the best methods for generating evidence, and the capacity of the clinical trials enterprise to supply sufficient amounts of high-quality evidence needed to ensure confidence in guideline recommendations. As such, the study calls for a “comprehensive redesign of the clinical trial enterprise.”
The study, titled “Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010,”examined fundamental characteristics of 96,346 interventional clinical trials registered in the ClinicalTrials.gov database in three major areas: cardiovascular, mental health and oncology. Study authors looked at:
- Characteristics of registered clinical trials as reported data elements in the trial registry;
- How those characteristics have changed over time;
- Differences in characteristics as a function of clinical specialty; and
- Factors associated with use of randomization, blinding, and data monitoring committees (DMCs).
The results: study authors found that ClinicalTrials.gov is dominated by small clinical trials and lacks consistency in methodological approaches. They also noted a deficit in evidence to support key decisions in clinical practice guidelines and insufficient numbers of volunteers.
“These findings raise important issues that should be addressed by detailed, specialty-oriented assessments of the utility of the large number of small trials,” the authors wrote. “A comprehensive collection of all clinical trials on a global basis would enable the most effective examination of evidence to support medical decisions.”
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