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    • Global Clinical Trial Standards
    • Registration, Disclosure & Authorship
    • Compensation to Investigators
    • Compensation to Trial Participants
    • Compassionate Use Policy
    • Stem Cell Research
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• Investigator-Initiated Research

Policy on Compensation to Investigators in Clinical Trials

1. Purpose

This policy describes Pfizer standards with respect to compensation of investigators during the recruitment and conduct of clinical trials/clinical studies sponsored by Pfizer. As a research-based pharmaceutical company, Pfizer 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 for Pfizer.

Pfizer 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 policy is part of a larger Pfizer effort to address potential conflicts of interest that include investigator training and other educational activities.

This policy addresses payment to investigators and/or their institutions for work associated with the conduct of clinical studies.

2. Scope

This policy applies globally to all Pfizer-sponsored studies. This SOP applies to Pfizer colleagues within Worldwide Development (WWD), Safety and Risk Management (SRM), Worldwide Regulatory Affairs and Quality Assurance (WRAQA), Worldwide Medical, and the Pfizer Country Organizations (PCOs – Medical, Regulatory, Safety) in Worldwide Pharmaceutical Operations. It also applies to those parties with which Pfizer contracts (e.g., Contract Research Organizations [CROs] or consultants) who are involved in Pfizer-sponsored studies.

This policy sets forth minimum standards with regard to compensation of investigators in Pfizer-sponsored studies and implements the U.S. Pharmaceutical Research and Manufacturers of America (PhRMA) Principles for Conduct of Clinical Trials and Communication of Clinical Trial Results and the Pfizer Global Policy on Interactions with Healthcare Professionals. The policy 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.

3. Policy

Pfizer compensates outside investigators for their work in conducting Pfizer-sponsored clinical studies and for providing services to Pfizer 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.

Pfizer shall not 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 is acceptable, but must be appropriately documented and must adhere to the Pfizer Global Policy on Interactions with Healthcare Professionals.

Pfizer has the following additional requirements for compensation to clinical investigators:

• 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 Pfizer 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 Pfizer 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, Pfizer 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 the Pfizer Global Policy on Interactions with Healthcare Professionals. For studies conducted in the U.S., 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 Pfizer stock.

4. Responsibilities

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.