Development of Clinical Trial Agreement Principles

Abstract

Background: Contract negotiations between academic sites and pharmaceutical companies, which often include contentious issues such as publication rights and indemnification, are perceived to be delaying the initiation of clinical research to the detriment of academic sites and patients. Given the need to improve the contract process in Ontario, the Council of Academic Hospitals of Ontario (CAHO) led an initiative that developed a set of standard principles that Ontario hospitals are recommended to follow when negotiating clinical trial agreements with industry sponsors.

Methods: A committee comprising members from academic hospitals and organizations across Ontario was formed. This CAHO Steering Committee on Harmonizing Clinical Trial Agreements set up a working group to draft a principles document based largely on preexisting principles. The draft principles went through several iterations of review and revision by the committee and by the member hospitals. A mechanism to ensure keeping it a live and up-to-date document was developed.

Results: The initial hope of the committee was to develop a standard clinical trial agreement for use by all sites and all companies; however, the committee felt that this was unlikely given the diverse interests and head offices of the pharmaceutical companies. As such the committee developed a standard set of principles to be used for contract negotiation; this document started with a superior set of principles, and then addressed a number of issues including publication rights, intellectual property issues, confidentiality, privacy, and indemnification. This document is currently being used widely by Ontario hospitals, and may be useful for other jurisdictions.

Interpretation: Publication of the standards for clinical trial agreements increases consistency in the standards applied by teaching hospitals and allows companies to develop or refine their templates to address the principles thought to be important by all Ontario teaching hospitals. Company templates that are in line with these principles are expected to require far less negotiation, if any at all.