Clinical trials for medical devices FDA
At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important medical devices—devices, such as implantable heart devices, that carry the greatest risk to patients and have the potential to save or sustain life.
One information gap is that there are not enough women enrolled in some clinical trials.
Why is that a gap?
Underrepresentation of women (or minority or ethnic groups) results in a lack of information for these patients and their physicians regarding risks and benefits of some medical products. Certain differences between women and men—including anatomy and physiology—can lead to medical devices performing better or worse.
FDA is actively trying to learn more about how to optimize the safe and effective use of medical devices in women.
With support from FDA’s Office of Women’s Health, CDRH recently performed an analysis of data from multiple clinical trials conducted in support of cardiac resynchronization therapy (CRT), a pacemaker therapy for patients with heart failure. Only 22% of the patients in the clinical trials were women. We combined individual patient data from multiple clinical trials to increase the number of women in the analysis.
We found that women benefit from CRT significantly more than men do. Patients of both sexes with a left bundle branch block (LBBB), an electrical conduction disorder in the heart, benefited most. However, women did so at a shorter QRS duration (time to complete electrical activation of the heart) than men. In the patients with LBBB and shorter QRS duration, women had a 76 percent reduction in heart failure or death, while there was no significant benefit in men. With LBBB and a longer QRS duration, both women and men benefitted from CRT.
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How many clinical trials does the FDA require?
The Food and Drug Administration decides on how many and to what extent of clinical trial's are necessary depending on the drug or product being tested. FDA staff members meet with researchers, and perform inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data.