Kevin Stone, MD, an orthopedic surgeon and chairman of the Stone Research Foundation in San Francisco, has an interesting idea for reforming the FDA: In Dr. Stone’s view, FDA should continue to require Phase I clinical trials to ensure safety, but the additional phases of clinical trials, which can be lengthy and end up bankrupting many companies, would be done away with.
In this plan, if a product is shown to be safe in a Phase I study, it would be released to the marketplace to a defined number of users. An Internet-based real-time post-market surveillance system would track the adverse events; any complication would be posted on the Web for anyone to see. In addition to improving transparency, this system would tap into the power of crowdsourcing, where experts who don’t happen to work for the FDA could share their analysis of the medical device’s pathway to the marketplace. Of course, products that pass the Phase I study but are later associated with complications would be pulled from the marketplace. But those that continue to be safe and effective could remain.
Device manufacturer's time to market would be accelerated and the cost would be drastically reduced, as they now only need to to fund a Phase I clinical trial. For companies with products that were shown to be safe, they would also have quicker access to a revenue stream.