Clinical trial sponsor

The sponsor is the individual, company, institution or organisation which takes responsibility for the initiation, management and setting up of the financing of a clinical trial. The concept is defined by Regulation (EU) No 536/2014 and adopted by the Public Health Code for all research involving human subjects. The sponsor may be a pharmaceutical company, but also a healthcare institution, a university or an association, hence the distinction between industry sponsorship and academic sponsorship.

Obligations of the sponsor

The sponsor submits the application for authorisation, ensures compliance with the protocol and with good clinical practice, guarantees the quality of the investigational medicinal product and organises the safety monitoring of participants. It reports suspected unexpected serious adverse reactions, submits an annual safety report, notifies the end of the trial and publishes the summary of the results. Where it is not established in the Union, it must appoint a legal representative there, unless a Member State allows a derogation for trials conducted solely on its territory. Several sponsors may share these responsibilities under a co-sponsorship arrangement.

Delegation and liability

The sponsor may entrust all or part of its tasks to a contract research organisation or to other service providers without thereby being relieved of its responsibility. Under French law, for interventional research, the sponsor bears the compensation of the harmful consequences of the research for participants, unless it proves that the damage is not attributable to its fault or to that of any person involved, and it must take out insurance covering its civil liability. The relationship with the investigator, who conducts the trial at a site, remains distinct and is governed by contract.

Contracts and ownership of results

Agreements concluded with healthcare institutions and investigators govern ownership of data and results, confidentiality and the conditions of publication. For industry-sponsored research conducted in public healthcare institutions, French practice uses a single agreement based on a template set by the public authorities. A precise intellectual property clause should provide for the allocation of inventions made in the course of the trial, the period for reviewing draft publications and the possibility of delaying their dissemination so that a patent application can be filed. In academic sponsorship, management of the rights in the results is often entrusted to a technology transfer office.

Key points

The sponsor bears regulatory and civil responsibility for the trial, even where it delegates its performance. Sponsor status follows from the initiation, management and financing of the research, while the practical conduct of the trial is a matter for the investigator. Before the first patient is enrolled, it should be checked that the site agreements settle ownership of inventions and provide for a publication review period compatible with a patent filing.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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