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As research-based pharmaceutical companies, sponsor or a CRO’s (collectively known as “biopharma” throughout the article) recognizes the critical role clinical research plays in the development of new medicines and the advancement of medical knowledge, as well as the need to offer fair compensation to investigators for their efforts associated with the conduct of clinical studies. Biopharma also recognizes that compensation provided to clinical investigators must not create conflicts of interest that could jeopardize the health or welfare of human subjects participating in a clinical study or that could affect, directly or indirectly, the design, conduct, analysis, or reporting of the study.
This article is part of a larger effort to address potential conflicts of interest that include investigator training and other educational activities, and addresses payment to investigators and/or their institutions for work associated with the conduct of clinical studies.
This information should be applied to all biopharma colleagues and to those parties with whom biopharma companies work with. It applies to compensation for investigators for all studies. This article sets forth minimum standards with regard to compensation of investigators in clinical research activities and implements the US Pharmaceutical Research and Manufacturers of America (PhRMA) Principles for Conduct of Clinical Trials and Communication of Clinical Trial Results and biopharma’s policies on interactions with healthcare professionals.
It is imperative to note that this information does not relieve investigators of their responsibility to address potential financial and other conflicts of interest with their institution, legal counsel, and/or the Institutional Review Board/Independent Ethics Committee (IRB/IEC) responsible for review of the clinical study.
Biopharma companies compensate outside investigators for their work in conducting sponsored clinical studies and for providing services related to those studies. Such compensation should be fair, reasonable, and generally commensurate with the fair market rate for such work. The rate of compensation may take into account factors such as required procedures, time commitment, study complexity, and locale.
Biopharma companies cannot provide financial compensation to investigators for the conduct of clinical studies in the form of consulting agreements or honoraria. Financial compensation for consulting or other services related to the study or the research program and not directly related to investigator study conduct may be acceptable, but must be appropriately documented and must adhere to the a biopharma’s policies on interactions with healthcare professionals.
The following requirements for compensation to clinical investigators should be adhered to:
• The financial compensation to investigators and their institutions must be linked to their
performing specific and necessary services (e.g., medical procedures, collection of data).
• Notice of the financial relationship between biopharma and the investigator/institution should be disclosed to study subjects in the informed consent. Such disclosure should generally consist of a statement such as the following: "The investigator or his/her institution is receiving compensation from the study sponsor for the investigator's participation in this clinical study."
• The financial compensation must be specified in a written contract describing the nature of the research services and the basis of payment.
• The financial compensation must be reasonable relative to compensation for similar clinical studies sponsored by the pharmaceutical/biotechnology industry in the country where the research is conducted.
It may include reimbursement for reasonable travel, lodging, and meal expenses when clinical investigators or their staff must travel to meetings for a clinical study. Venue and circumstances for the meeting must be appropriate for the purposes of the meeting.
Financial compensation to investigators and their institutions or other clinical study personnel shall not:
• Be tied to the outcome of clinical studies.
• Include stock or stock options for work on individual studies.
• Include payments to physicians outside a clinical study for referring subjects to investigators for entry into that clinical study.
• Include special incentives such as enrollment bonuses, awards, or gift certificates that are designed to reward the achievement of subject enrollment goals within a specified time period. Should enrollment in a study be particularly challenging, biopharma companies may compensate investigators, their institutions, or other clinical study personnel for extra recruiting expenses to enroll appropriate subjects. For example, compensation may cover such expenses as additional advertising costs.
• Consist of additional incentives or rewards, except those prospectively identified in the
Clinical Study Agreement or approved by the IRB/IEC. Acceptable incentives could include, for example, those for timely reporting of data subsequent to subject enrollment. Such monetary or non-monetary incentives must be consistent with the local laws of the country in which the studies are being conducted and with a biopharma’s policies on interactions with healthcare professionals.
For studies conducted in the US, non-monetary compensation must also conform to the American Medical Association Guidelines on Gifts to Physicians from Industry. Investigators or their immediate families shall not have direct ownership interest in the specific pharmaceutical product being studied. This provision does not preclude direct ownership of stock.
Every study team is responsible for compliance with this policy. If a country-validated fair market value range of per-subject costs has been established for a particular study, study team approval of compensation rates outside that range must be justified, approved by senior management, and documented. Exceptions to this policy may not be made without written approval of senior management and Legal.
With this above information it is imperative to note that biopharma companies must actively seek out and request supporting documentation for any budget items that fall outside of a study’s parameters or may not adhere to Fair Market Value Standards.
Some sites may push back on the request for info as they feel that since certain costs/procedures are their true costs that should be more than enough documentation for the CRO or Sponsor.
As a professional reply to that statement, it has been very useful to inform the site(s) that every individual study team is responsible for compliance with the policy of providing documentation, and if a country-validated fair market value range of per-subject costs has been established for a particular study, study team approval of compensation rates outside that range must be justified, approved by senior management, and documented. Sites are also educated and informed that exceptions to this policy may not be made without written approval of senior management and legal.
Justification provides assurance that all payments are appropriately distributed and serve support and document compliance with requirements in a standard manner for regulatory authority inspections and internal biopharma audits. Biopharma companies look at these justifications very closely and in the past have audited those budgets that have gone over the maximum. Thus, it is important that documentation/justifications are provided.
Documentation will also ensure that all payments are fair, reasonable and generally commensurate with Fair Market Value (FMV) and will not create conflicts of interest that could jeopardize the health or welfare of human subjects participating in a clinical study, or that could affect, directly or indirectly, the design, conduct, analysis, or reporting of the study. The policy of providing documentation is a part of today’s biopharma company’s larger effort to address potential conflicts of interest that include payment to investigators and/or their institutions for work associated with the conduct of clinical studies. In essence, services related to the study or the research program and not directly related to, must be appropriately documented and must adhere to the policies on Interactions with Healthcare Professionals.
Bottom line, Fair-market value has recently become a notoriously contentious concept to master in clinical trial negotiations, especially in Phase III studies, since there are no defined regulations or procedures for calculating clinical budget and PI compensation. With state compliance guidelines changing almost on a daily basis, increased inflation and the potential introduction of federal guidelines on the horizon, many sites are really beginning to push back on what many biopharma’s deem as “fair” and “reasonable”.
Editor’s Note: For more on the topic of clinical trial budgets and negotiation from the site and sponsor view, please register for these two free on-demand webinars.
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