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Prevalence of control groups in cardiovascular clinical trials: An analysis of ClinicalTrials.gov from 2009 through
Alexander R Zheutlin1, David J Caldwell2, Jad Al Danaf3
1Department of Internal Medicine, University of Utah, Salt Lake City, UT, Seattle, WA.
Insights
Most cardiovascular clinical trials use a control group for accurate results. Between 2009 and 2019, over 80% of Phase III and IV trials included a control, showing consistent practice.
Area of Science:
- Cardiovascular Medicine
- Clinical Research Methodology
- Evidence-Based Practice
Background:
- Clinical trials are essential for patient care decisions.
- Comparing interventions to control groups is crucial for evaluating therapeutic effects and safety.
- Understanding the use of control groups in cardiovascular trials is important for research integrity.
Abstract:
Clinical trials provide the foundational evidence that guide many patient-facing decisions; however, the therapeutic effect and safety of an intervention is best evaluated when compared to a control group. We used ClinicalTrials.gov to describe the proportion of registered Phase III and IV cardiovascular clinical trials that contain a control group from 2009 through 2019. Of 1,677 registered Phase III and IV cardiovascular clinical trials, 81.2% contain a control group, and the annual prevalence remained unchanged between 2009 and 2019.
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