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MDSI Collaborates with FDA on Device Study
The quality of clinical data submitted by manufacturers to support Food and Drug Administration cardiovascular device premarket approval (PMA) applications varies widely and formal quality assessment has not been previously performed. MDSI collaborated with FDA to evaluate all original cardiovascular device PMAs with Food and Drug Administration decisions between January 1, 2000, and December 31, 2007, to assess the quality of clinical investigations submitted by manufacturers.
Key Study Findings:
- 88 cardiovascular device PMAs, 132 clinical studies, 37,328 study subjects, and 29,408 device recipients were analyzed. Key cardiovascular comorbidities were infrequently reported (coronary artery disease 51.1%, diabetes 36.6%, hypertension 35.2%, heart failure 37.5%, tobacco use 31.8%).
- Primary effectiveness end points, primary safety endpoints, and subject accounting were deemed high quality in 81.8%, 60.2%, and 77.3% of pivotal studies, respectively.
- Studies infrequently reported subject race (14.8%); when race was reported, 13.7% of subjects were non-white.
- Studies rarely included patients younger than 18 years of age (10.2%).
- Women were less often enrolled in the studies than men (33.9% vs. 66.1%).
Study Conclusions:
- Poorly defined safety and effectiveness end points, poor patient accounting, and incomplete collection of important patient comorbidities make device safety and effectiveness assessments more challenging.
- Women, pediatric, and nonwhite populations are underrepresented in premarket cardiovascular clinical trials.
- Manufacturers, regulators, and the clinical community should collaborate to address these study shortcomings to ensure that patients are treated with reliable, safe, and clinically useful medical devices.
MDSI Medical Device Safety Testimony Click here to read the MDSI-FDA study.
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