Such useful data is hard to come by, said Alan Hopkins, president of PharmaStat, which advises companies on clinical development. "Usually the only source of data is published reports," he said, echoing Bangs that, while difficult to get, reports of failed studies could be particularly useful. But Hopkins, former head of biostatistics and clinical information technology at Genentech, is highly skeptical that companies would be willing to share the data. "Persuasion by editorial committees probably wont make this happen," he said. The FDA is soliciting public comment for technologies to shorten clinical trials, but I am unaware of any position on a mandatory registry.Opponents of the registry may argue that it could be more misleading than informing. All three of these experts would agree that not all clinical trials are equal. You cant determine the efficacy of the drug by taking a poll of trial results. Some trials are better designed and more telling than others. And these trials should matter less in making models or health care decisions. This is precisely why the registry needs to be constructed carefully. "Theres got to be a standard for putting this information in a repository," said Hopkins, one that would specify required elements. And it should support more than text searching, he said, slipping into biostatistician patois, imagining an appropriate XML to search sample sizes, endpoints and more. If companies supply the data, experts will crunch them. And maybe, just maybe, the cost of clinical development will start to decline.
To read about the FDAs push for better predictive technology, click here.