Drug Clinical Trials Being Outsourced With Little FDA OversightApr 21, 2008 | Parker Waichman LLP
Drug makers are increasingly outsourcing the running of clinical trials to outside companies, known as Contract Research Organizations (CROs). Clinical trials are meant to test the safety and effectiveness of experimental drugs before they come to market. Yet despite the importance of such studies, an article in Sunday's "San Jose Mercury News" reported that CROs operate with very little regulatory oversight.
It is not unusual for drug companies to hire outside companies to manage drug studies, including clinical trials which involve human subjects. That reality was made apparent last week, when it was learned that Merck had used an outside firm to write Vioxx studies, and then paid prominent researchers to list their names as authors of the studies. Drug makers like CROs because these companies are able to conduct studies quickly, in part because many of them maintain worldwide networks of researchers who can participate on short notice. According to the "Mercury News", drug companies like CROs so much, they have become a billion dollar business. In fact, one of every five dollars biomedical firms spend on research and development goes to outside experts - particularly CROs, which number at least 700 in North America and Europe.
But critics of CROs say that the Food & Drug Administration (FDA) is not doing enough to oversee these organizations. The "Mercury News" report said the FDA inspected just 1 percent of the estimated 350,000 sites where studies involving human subjects were done during the 2000 to 2005 fiscal years. Moreover, an increasing number of such studies are being done in foreign countries, where the FDA has limited authority. That means the pharmaceutical companies must be counted on to oversee the CROs they hire, but no one knows if they are doing this adequately.
In the rare instances that the FDA does inspect CRO clinical trials, it sometimes finds problems. In February 2007, Gilead Sciences reported to the Securities and Exchange Commission that the FDA had found "certain irregularities" in studies a contract research outfit had done for it. A Gilead spokesperson told the "Mercury News" that the contractor involved was called MDS Pharma Services, and said the problem occurred in studies intended to check how some of Gilead's drugs - including its widely used HIV treatment, Viread - reacted with other medicines. As a result of the problems, information on drug interactions on the Viread label might need to be modified.
The Gilead incident is not the first time that MDS Pharma Services has been cited for irregularities with clinical trials. After a series of inspections at two MDS sites in Canada, the FDA last year also warned an undisclosed number of the firm's clients, saying the agency's checks of MDS studies "raise significant concerns about the validity of the reported results." An MDS spokesperson would not tell the "Mercury News" how many of the companies contracting MDS got the FDA warning or whether MDS was at fault. However, the newspaper was told that MDS is working to resolve problems.
Unfortunately, because of a lack of regulatory oversight, know one knows how many CRO clinical trial have run into problems. While the FDA has said that it is working to improve oversight of CRO studies, many critics are not optimistic, given that the agency has limited resources and that are already stretched too thin.