The Association of Clinical Researchers and Educators (“ACRE”) recently distributed model guidelines on physician and pharmaceutical industry interactions (Statement). ACRE plans to educate physicians employed by academic medical centers, medical schools, and professional medical associations about the Statement. This Bulletin highlights the provisions of the Statement that are most relevant to pharmaceutical companies.
1. Research Funding
A pharmaceutical company often supports research by physicians, whether by directly sponsoring clinical studies conducted by physicians or by supporting research initiated and conducted by physicians. At the outset of these studies, ACRE recommends that the company and investigators determine how the company’s funding will be allocated and earmarked. ACRE also suggests that the company and the investigators clarify the protocol to be followed if any excess funds become available, and whether the investigators may allocate these funds to support other projects.
2. Payments to Physicians during Industry-Sponsored Studies
When a pharmaceutical company decides to sponsor a study conducted by physicians, the Statement indicates that the company should compensate these physicians for any professional services they provide which are “meaningful and time-consuming.”
a) Payment Amount
Sponsors should pay physicians less than an amount which is “designed to encourage favorable outcomes from the physician,” but also higher than an amount which would undervalue their work.
b) Payment Method
Sponsors may pay physicians for their research in different ways, depending on the rules of the research institution affiliated with the study. The following are four potential options for payment:
the sponsor pays the research institution affiliated with the study, which then pays the physician as part of his or her salary;
a foundation associated with the study pays the physician directly;
the sponsor pays the physician directly; or
the sponsor pays the physician royalties if the physician makes a significant discovery during the study, as long as the physician’s equity interests are clearly disclosed.
c) Payment Timing
Sponsors should be cautious about the timing of their payments to physicians involved in the study
to avoid the appearance of physician conflicts of interest. The payment may be perceived
as creating a conflict of interest if the sponsor pays physicians after the study results are analyzed;
increasing payment based on favorable results could compromise the objectivity of the results. As
such, once the study’s database is complete and the data is being analyzed, ACRE warns physicians
that “the appropriateness of receiving compensation from a sponsor should be reconsidered.”
3. Physicians as Public Spokespeople
Frequently, pharmaceutical companies request that physicians speak publicly on their behalf. ACRE recommends permitting faculty physicians who serve in this capacity to speak about scientific and clinical data results from their research. Further, ACRE suggests allowing faculty physicians to speak about scientific facts in any underlying research if this discussion illustrates important issues, even if the physicians did not conduct the underlying research. According to ACRE, pharmaceutical companies should have their own internal spokesperson who can explain company positions.
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