02 September 2016

The ins and outs of clinical trials

Sharmela Thevarajaha
Associate | UK

In the series she highlights the crucial legal, ethical and business issues to consider when negotiating these key provisions including payments, intellectual property, insurance and publication rights.

Clinical research collaboration plays a significant role in developing medicines, advancing medical knowledge and enhancing patient care.

Without clinical trials, pharmaceutical companies (the sponsors), wouldn’t be able to get drugs to market in order to save lives and continue to build a real world body of knowledge around medicines.

Clinical trial agreements are laden with detail to capture the commercial, ethical and financial obligations of the sponsor, institution and the principal investigator (being doctor/ lead researcher conducting the clinical trial). Considering the detail involved experienced and educated negotiation is essential for all parties to reach a consensus and save time, money and resources.

The list of provisions is intended as a high-level guide only and is not intended to be comprehensive and certainly does not capture every provision that can be found in a clinical trial agreement.

First up – Obligations.

Obligations of the sponsor – The sponsor’s main role is:
• Initiating, managing and financing the clinical trial.
•Creating the protocol setting out the goals of the clinical trial.
•Arranging training for the principal investigator (PI) and others involved in the clinical trial.
•Being responsible for data protection matters; and monitoring and safety reporting to regulatory authorities.

The sponsor must be satisfied the protocol, research team and research environment have passed scientific quality assurance and the trial has received approval from the relevant regulatory body and ethic committees before it begins.

Obligations of the clinical research organisation (CRO) – The management of a clinical trial is an incredibly time-consuming and resource intensive activity that many sponsors outsource to a CRO but the ultimate responsibility for the quality and integrity of the trial data remains with the sponsor. The International Conference on Harmonisation Guidelines for Good Clinical Practice recommends any trial-related duty and function which is transferred to and undertaken by the CRO is specified in writing. Non transferred duties remain with the sponsor.

Obligations of the institution – The institution must recognise both the legal and ethical responsibilities it owes to the subjects and the sponsor. The institution is responsible for:

•The clinical trial site and facilities.
•Complying with the protocol.
•Ensuring the PI and any other staff are executing the trial in accordance with applicable laws, industry best practices, ethics committee accreditation, standard operating procedures and monitoring protocols.
•Verifying academic and professional qualifications, experiences and the training of the PI and the research staff.

Obligations of the PI – The PI’s main role is:
•Supervising the clinical trial and ensures the welfare of the clinical trial subjects.
•Providing medical assistance to subjects.
•Obtaining consent from the subjects, ethics committee approvals, and any other approvals required to perform their obligations.

When negotiating the clinical trial agreement, the parties should also consider what rights the sponsor has in the event the PI can no longer act as the PI, such as the institution seeking prior written approval for a substitute PI from the sponsor.

Also, PIs may be involved in competing clinical trials simultaneously, which could lead to a conflict of interest. If this is a concern, the sponsor should have a requirement in the contract preventing this.

Last and certainly not least, is the transfer of obligations in clinical trials.

The transfer of rights and obligations are most commonly dealt with in the assignment provision of the agreement. As the sponsor is ultimately responsible for the trial, no party (CRO, PI and institution) should be able to transfer any of their obligations without the sponsor’s express consent.

Also, as a sponsor, if one of the party is not performing, it should have the ability to remove them and either step in or arrange for a third party to step in. The PI and institution in particular may not find this stance acceptable, however, unless it’s commercially unviable to give up on this point, it’s best to state that the PI and institution cannot assign or transfer the agreement without the sponsor’s permission.

Sharmela Thevarajaha Associate | London, Cambridge

Category: Blog