Clinical Trial Agreement Essentials
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What is a clinical trial agreement (CTA)?
A Clinical Trial Agreement (CTA) is a legally binding agreement that defines the relationship between the sponsor of the trial and the clinical investigator/institution conducting the trial. The CTA is important since it delineates the allocation of risk, responsibility, funds, obligations, and the protection of academic, legal, intellectual property and integrity.
However, any departure from a CTA seldom leads to legal actions from one of the two parties. The CTA should be seen as a fee-for-service contract whereby the clinical investigator is paid for the extra time that he/she performs as inducted by the study.
An industry-sponsored clinical trial agreement is usually a two-party agreement between the investigative site/institution and the trial sponsor. It can also be a three-party agreement that involves a clinical research organization (CRO).
There have been many efforts to develop a master or model CTA aimed to be suitable for all sponsors and investigators worldwide, but those initiatives have so far not been successful. The main reason for this is that each company has its own legal framework and each site must adjust the CTA to the requirements of its own jurisdiction.
It is advisable that a study site works with someone who has experiences in developing and negotiating a CTA. This person could be employed by an academic institution, be an experienced person at the study site, or an external consultant. However, it is not advisable to involve a legally qualified professional without previous experiences in executing CTAs; this will just delay the process and make the CTA too detailed to be acceptable by the sponsor.
Signing a CTA proposed by the sponsor without a full review of the agreement is also not advisable. Any contractual terms that are not reasonable or acceptable should be negotiated prior to accepting the terms of a CTA. It is quite common that the sponsor states that many other sites have already signed the sponsor’s CTA and that a negotiation process will not be fruitful and only delay the initiation of the study at the site. Please take your time to review the agreement and involve a person that is experienced in reviewing CTAs. It is, after, all a legally binding agreement between two parties.
Liabilities and indemnity
This is a special note about Liabilities and indemnity in clinical trials. A clinical trial aims to test a new medicinal product not yet accepted for use in everyday clinical practice. For this reason, the sponsor needs to take up the full responsibility for any adverse event related to the test product. Adverse events that occur as a result of a clinical trial cannot be covered by the clinics/hospital insurance related to normal clinical practice.
The sponsor must buy insurance especially for a clinical trial insurance, and a copy of the valid insurance should be given to the site. Many ethics committees will not review a clinical trial without a valid copy of the clinical trial assurance. The sponsor will often accept this arrangement and will provide a copy. When it has not been provided, and when it is needed, the chairman of the local ethics committee is recommended to write a letter to the sponsor about this requirement.
For an example of a CTA that aims to protect the study site, one could refer to the UK Model. The model Clinical Trial Agreement (mCTA) is designed to be used without modification for industry-sponsored trials throughout the UK Health Service.
The headings of this CTA are listed below; the headings given in bold are of specific interest and importance for the study site:
- Investigator and trial site team members
- Clinical trial governance
- Obligations of the parties and the investigator
- Liabilities and indemnity (see comments below)
- Confidentiality, data protection and freedom of information
- Intellectual property
- Financial arrangements
- Early termination
- Relationship between the parties
- Agreement and modification
- Force majeure
- Rights of third parties
- Dispute resolution