What the contract does not say… A current analysis of what’s missing in clinical trial agreements

Abstract

Introduction. Increasing numbers of litigation cases in clinical research highlight the need for definitive and transparent clinical trial agreements (CTAs). The requirements set by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) are an attempt to minimise miscommunication between sponsor and site, and promote human research protection. These requirements include: (i) the obligation of the sponsor and/or its representative to communicate study results; (ii) the obligation of the sponsor and/or its representative to promptly report any findings that could affect the participants’ safety and/or influence study conduct; and (iii) the sponsor’s liability for the cost of medical care in the event of a research-related injury.

Objective. To analyse 40 CTAs as to which of the AAHRPP requirements they met.

Methodology. Forty consecutive CTAs signed by our institution, with 15 different research sponsors, were analysed and tracked as to which AAHRPP criteria they met.

Results. No CTAs complied with all the AAHRPP requirements. Notably, 17.5% stipulated that the sponsor would communicate study results, but none stipulated that it would directly inform the site of these results; 35% stated that the sponsor would be responsible for reporting any findings/additional information that might affect participants’ safety and/or influence the conduct of the study; and 40% explicitly stipulated that the sponsor was obliged to pay for the cost of patients’ medical care in the event of a research-related injury.

Conclusions. The AAHRPP requirements are an attempt to minimise miscommunication between sponsor and site, yet most CTAs fail to stipulate what should be fundamental requirements of every contract.