A top Food and Drug (FDA) official stated the organization is developing guidelines that will establish stricter scientific standards for data from tests on humans that medical device manufacturers submit when seeking approval of their products. The FDA will most likely urge device makers to, for example, use more sharply defined targets to determine the success of clinical trials. The agency may also urge producers to follow patients in trials more carefully to ensure the targets are met. This statement comes before two studies that found inadequacies in some clinical trials accepted by the FDA over the past ten years in connection with the approval of high-risk cardiovascular devices, such as defibrillators, pacemakers and coronary stents. Researchers from the FDA and Beth Israel Deaconess Medical Center in Boston conducted one of the studies, while the other was conducted by researchers at the University of California, San Francisco and published in the Journal of the America Medical Association (JAMA). Both of the studies researched the scientific quality of the clinical trials submitted to the FDA from 2000 to 2007.
The FDA-sponsored study found that more than forty percent of the studies used to approve cardiovascular devices had lacked high-quality data regarding either the treatment or safety goals of the study. Further, the study also found that about twenty-five percent of trials had failed to sufficiently follow the results of about ninety percent of patients involved in the trial. Although no correlation was found between lower-quality data and problematic devices, there is certainly potential that such linkages existed. The University of California, San Francisco research was a bit more critical of the FDA and concluded the FDA had permitted cardiovascular devices based on data that "lacked adequate strength." The FDA disagreed with these findings, claiming the JAMA article had applied scientific criteria used to evaluate studies of experimental drugs to trials of medical devices, which they said are run differently for both technical and regulatory reasons.
In recent years, the FDA has faced criticism from legislators, patient advocates and researchers for the standards it uses to approve devices. It has further faced intense scrutiny after a Supreme Court decision blocked manufacturers of high-risk devices from patient lawsuits if the FDA approved their product. Since 2007, the FDA has claimed to make significant changes in their review process. For example, agency reviewers began using a standardized checklist to assess the scientific merits of trial designs submitted by manufacturers. This year, the agency is also expected to distribute guidelines to manufacturers about what they expect in clinical studies.