The Five Legal Pitfalls Of Clinical Trials Agreements

Collaboration between pharmaceutical companies, research organisations and hospital trusts, and the resulting clinical trials of new products and processes are an essential part of getting new drugs to market. Clinical trials are, of course, subject to a high degree of regulation, with multiple parties being involved in their successful execution. It is therefore not surprising that the contractual framework surrounding said trials may be complex.

What is a clinical trial agreement?

A clinical trial agreement ("CTA") is the legally binding agreement between a sponsor, usually a pharmaceutical company which provides the study drug or device and financial support, and the host institution, often an NHS hospital or Trust which provides the data and results of interest. However, other parties may be involved in the execution of the trials, such as a contract research organisation, clinicians, manufacturers, suppliers, and, of course, patient volunteers. The roles and responsibilities, and perhaps most importantly, liabilities, of each party must be clearly defined before any trial is undertaken.

This article does not aim to consider all of the issues which may arise in relation to a clinical trial, which may be many. Instead, we talk through an overview of some of the key issues that must be addressed in any CTA.

1. Form of agreement

   CTAs differ from standard commercial services agreements because they focus on the protocol of a trial and risk, rather than commercial benefits or financial gain. Clearly, there may be a direct risk of harm to human volunteers who are the subjects in any trial. Furthermore, a party to the agreement is likely to be an NHS hospital, i.e. not a commercial entity. The considerations are therefore different.

   In the UK, there are several approved model templates which are endorsed by the Government and are, generally speaking, preferred by NHS Trusts. The room for negotiation is often therefore different to normal commercial practices. That said, it is still important for sponsors to ensure that their interests are best protected.

   The CTA itself is the main agreement that governs the trial, but given the complexities of clinical trials and the number of parties involved in bringing them to fruition, there will be other agreements in the background. Such agreements will include manufacturing and supply agreements, agreements with a qualified person who certifies the product for trial, consultancy agreements with...