Pharma companies know they have to reach out to new and inexperienced investigators to maintain capacity for growth in emerging regions. Investigator capacity is a major issue in these markets because they have experienced such significant growth in recent years. In the U.S., though, companies have taken more of a sink-or-swim approach when introducing physicians to clinical research, and they could be making a big mistake.
In the U.S. new sites are often given a chance to participate in clinical trials through competitive enrollment. If they meet patient numbers by a deadline, then they participate. If not, they waste a lot of time and energy for nothing, because often they don’t get a second shot at it.
Call it ‘natural site selection,’ but it doesn’t work. By offering competitive enrollment, pharma companies are potentially cutting off a new supply of qualified clinical research investigators before they get a chance to contribute.
In 2001, CenterWatch identified a shortfall in the number of U.S. clinical research investigators as a bottleneck in clinical research. By 2005, it became clear that the number of investigators conducting clinical research was not increasing at the same rate as the number of clinical trials. Older, experienced investigators were retiring faster than newer investigators were coming on board.
In a recent Thomson Centerwatch survey of more than 7,000 physicians, about half report they do not participate in clinical trials. Centerwatch data indicate that the greatest barrier to an investigator’s participation—for the first time or subsequent times—is the time commitment.
Perhaps surprisingly, only 9% of investigators cite money as a reason to participate in clinical research. The idea that physicians enter into clinical research to chase “easy money” is largely a myth. Those who do most likely will burn out quickly. The 49% of physicians who do enter research and remain involved in trials rank professional development, interest in research and a drive to improve patient care as key motivators.
Pharma companies would do well to recognize the motivations behind prospective investigators’ willingness to participate in clinical research and cultivate them. Site selection by both pharma companies and contract research organizations, to which they often outsource this activity, needs to be improved a great deal in order to have a healthy supply of clinical research investigators available to conduct their clinical trials in the U.S.
Clinical trials will always have to be conducted in the U.S., but the proportion of trials conducted here is getting smaller. Pharma companies, the government and medical schools would do well to ensure that we have physicians who are educated about the business of clinical research and are willing to conduct clinical trials.