Do clinical trials fit in a private medical practice?

Abstract

Although traditionally thought to be the purview of academic health centers, clinical trials to evaluate new drugs, tests, and devices are being done more and more in private medical practices or in healthcare organizations with little or no academic affiliation. There are many reasons for this observation. First, the sheer number of new medications and devices which are in development that need large numbers of patients to evaluate their effectiveness or readiness for clinical care requires a large number of study sites. There simply are not enough sites in academic settings to get the work done. One estimate puts the number of new products being studied at 37 000 [1]. Clearly, to enroll enough patients to study this number of products requires sites outside the academic environment. Second, the pace of development and the importance of rapid enrollment to keep costs down to improve the return on investment for the sponsoring company pushes many companiesto seek sites in nontraditional locations. Slow recruitment is costly for many reasons including the obvious delays in getting a product to market but also in the delay of cancelling development of a nonviable product that maybe even more costly. Third, participation by nonacademic study sites provides the opportunity for them to offer treatments or devices for their patients before their general availability. This process tends to create an additional level of credibility for the site because they are now working closely with well known academic locations to help develop new treatments for disease. This activity can be used to promote an image of innovation and knowledge that creates more prestige and patient volume. Fourth, a well developed clinical trial program can improve the finances of a practice or healthcare facility by providing an income stream not directly related to traditional patient care activities. Because this income stream comes through a contract with a for-profi tc ompany and not from a government program or healthcare insurance company, it provides a diversifi