association between the responses and familiarity with the codes of conduct of professional societies.

The studies reported here and in Chapter 5 occurred before the Pharmaceutical Research and Manufacturers of America (PhRMA) revised its Code on Interactions with Healthcare Professionals in 2008. These revisions, which set some limits on gift giving and other relationships and which are discussed further below, took effect in January 2009. The Advanced Medical Technology Association (AdvaMed) adopted similar revisions in its Code of Ethics on Interactions with Health Care Professionals, effective in July 2009. Thus, it is too early to gauge the effects of these changes on physician relationships with pharmaceutical and medical device companies.

Participation of Community-Based Physicians in Clinical Trials

As mentioned in Chapter 4, physicians in private office settings are increasingly participating in clinical trials that are sponsored by industry and managed by contract research organizations or research site management organizations. The percentage of clinical trials conducted in academic health centers has decreased, and academic health centers are now in the minority among the locations for clinical trials (Klein and Fleischman, 2002). The marketing aspects of some of these trials were described above. The involvement of practicing physicians in clinical trials in the community has potential benefits. For example, their patient pool may be more representative of all patients with the condition being studied than the patient pool of academic physicians, so the results may be more generalizable. Furthermore, the recruitment of participants and the conduct of the study may be more rapid and less expensive in the community setting than in academic medical centers. In addition, such trials may be educational for the participating physicians.

Several concerns have, however, been raised about conflicts of interest in industry-sponsored trials involving community physicians. First, payments to participating physicians may provide incentives to enroll and retain patients, but they may also exceed actual expenses. In guidance provided to pharmaceutical companies, the Office of the Inspector General of the U.S. Department of Health and Human Services has cautioned against payments that exceed fair market amounts for “legitimate, reasonable, and necessary services” (OIG, 2003, p. 21). Second, practicing physicians may have a powerful influence over their patients, perhaps more so than physicians in academic centers, which have high rates of turnover of residents, fellows, and faculty and which allow investigators studying common diseases to recruit participants who are not their personal patients.

In addition, some clinical trials in community practices may be “seed-



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