Physician remuneration in industry-sponsored clinical trials: the case for standardized clinical trial budgets

General principles for physician reimbursement

The Canadian Medical Association Policy on Physicians and the Pharmaceutical Industry16 has reinforced the principle of “reasonable” physician remuneration (Table 1). However, it does not specify which services should be included or how reasonable levels of compensation can be set. The policy stresses the importance of oversight of remuneration by an approved board, agency or body (which has the authority to approve the use of human subjects). Although all studies involving human subjects must undergo REB review, such groups have to date received no guidance in the matter of remuneration. For example, REBs are guided by the Tri-Council Policy Statement, which offers only that “REBs shall examine the budgets of clinical trials to assure that ethical duties concerning conflict of interest are respected.”19

One of the first needs, therefore, is for an informed debate to frame a consensus on parameters for reasonable remuneration for physicians participating in clinical trials. To start that debate, Table 2 shows a potential classification for physician remuneration in clinical trials and suggests possible standards for each group.

Standardizing clinical trial budgets

Agencies reviewing clinical trial applications at the institutional level (e.g., REBs) can assess potential conflicts of interest only if they see the clinical trial budgets — something that does not always happen today. Those budgets must be organized in a uniform manner that reflects the agreed categories of remunerable service. Absent access to a template budget for clinical trials, REBs may have difficulty evaluating what services are being remunerated and at what rate. We therefore suggest the use of a standardized budget template for classifying the categories of physician remuneration, regardless of the type of trial or location. It is premature to provide “best practice” parameters for these categories, but progress toward a common method of reporting categories of remuneration should lead to improved sector-wide communication and allow some basic standards for clinical trial budgets to emerge rapidly. Standardized clinical trial budgets would be based on categories, definitions and standards such as those in Table 2. At a minimum, the unit cost per patient for each service rendered should be easily identifiable in the budget, making it possible to determine what services are offered and for what cost. We recognize that flexibility in the template is needed to accommodate different study types (e.g., phase II versus phase III, or single versus multicentre trials), but greater standardization is still possible and, in our view, desirable.

Sharing of clinical trial budgets

The uncertainty about current practices arises not just from the lack of detail in current budgets, but also from the fact that they are rarely shared across institutions. Only with disclosure and discussion can “best practices” emerge with respect to physician remuneration. In addition to reducing potential financial conflicts of interest and conforming to broad principles of transparency and accountability, disclosure will promote equity in physicians' clinical trial remuneration. We believe that institutions and physician-researchers should reject any industry contract that prohibits appropriate disclosure of information about the financial arrangements or that allows only conditional disclosure. Disclosure also extends to patients. As such, physicians and site administrators should include a statement in the trial consent form about reimbursement for physicians and others involved in running the trial.

Although our focus here is on physician payment, institutional remuneration must also be considered in the near future. Some institutions receive funds from industry for actually running or administering a trial (e.g., overhead charges), for simply agreeing to participate in the trial (e.g., donations to the institution for that decision) or for other trial-associated activities, including related research programs and clinical services. “Sunshine rules” for all financial aspects of clinical study agreements, similar to those suggested above for physician remuneration, would mitigate potential institutional conflicts of interest.

Conclusions

Financial conflict of interest is subjective and may never be completely avoided. However, no one wants to see patterns of physician remuneration that could be interpreted as a threat to scientific integrity or good clinical judgement. Numerous editorials and empirical studies have examined conflict of interest,22^,23 and there is a consensus that some physician payments should be banned (e.g., finders' fees and completion fees). However, there has been surprisingly little debate about clinical trial budgets in general and reasonable physician remuneration. In this brief commentary, we have urged standardization of categories of remunerable services, agreement on how physician payment levels should be set and transparency regarding the budgetary provisions in clinical trial agreements. These initial steps would help physicians and those who manage their practice sites to address perceived, potential or actual financial conflicts of interest in clinical research.

𝛃 See related articles pages 889 and 892