The effective negotiation of a clinical trial agreement (CTA) is an essential driver for getting new drugs and devices to the market.
Parties should ensure that an executed CTA is in place before undertaking any work on a clinical trial. Whilst the Health Research Authority (HRA) encourages parties to use a model form of agreement in order to help speed up the contracting process, a number of contentious issues can make the negotiation process challenging. The HRA regularly publishes forms of agreement and seeks industry input into the drafting. With the template agreement as a starting point, some of the key considerations for life sciences businesses when negotiating CTAs are set out below.
Intellectual property (IP)
As always, the protection of IP rights is of vital importance to life sciences businesses in order to safeguard the significant investment in their products.
The sponsor will want to ensure it retains sole ownership of its pre-existing background IP as well as any foreground IP created in the course of the clinical trial. On the other hand, the institution or host will seek ownership rights in any foreground IP created and the right to use any know-how developed in future trials.
As such, sponsors should be careful not to assign any background IP to the institution, and limit the transfer of any foreground IP to a licence to use such information for purely non-commercial research or educational purposes.
Alongside other IP rights, an area of real importance to the sponsor is the protection of their confidential information during a clinical trial. Sponsors will seek a wide definition of confidential information to ensure all information is captured, as well as confidentiality obligations for the institution that subsist for as long as possible in order to ensure information is not used in another clinical trial to a competitor’s benefit.
Conversely, institutions will pursue lighter confidentiality obligations so that they can share improvements and the results of the clinical trial with the wider academic community. The sharing of results is one of the most contested issues in a CTA, and as a result source data (over which the sponsor cannot claim confidentiality) is often distinguished from the clinical trial results. Furthermore, sponsors may seek to prohibit a general publication of the clinical trial results, and pre-approve the form in which they are published.
Sponsors will seek to limit the sharing of confidential information to individuals on a “need to know” basis, and if including third parties only to those who have warranted that they will use the information with the same degree of care. However, confidentiality obligations that last in perpetuity after the completion of the clinical trial are often deemed unreasonable, and as a result most confidentiality obligations last up to 10 years.
A few other important areas to think about are:
Liability, risk and insurance are key in any agreement, and the importance of this is sharpened given that the CTA will need to adequately provide for the unfortunate risk that the trials have a detrimental impact on human volunteers. In the UK, the model CTAs commonly favour the institution or host site on these provisions, and the sponsor’s ability to negotiate them will depend on the context of the clinical trial and its bargaining position.
- Regulatory compliance
Clinical trials are subject to a high degree of regulation, and it is key to ensure that the principles of good clinical practice (GCP) are met.
- Data protection
This is of particular importance owing to the fact that healthcare data is defined as special category personal data under the legislation. Patients’ voluntary consent is required before they can participate in clinical trials, and parties often choose to anonymise data to aid compliance with data protection legislation.
The parties to a CTA must also ensure that they comply with data transparency requirements as regards pre-clinical and clinical trial data, especially in light of the implementation of the Clinical Trials Regulation.
Clearly setting out the scope, responsibilities and timelines in a CTA as well as recording agreement on division of risk and ownership rights will allow for a smoother clinical trials process and should help prevent disputes between the parties further down the line.