New and updated UK clinical trial agreement templates published on IRAS
There is little room to negotiate the terms of these UK standard agreements, but sponsors should consider internal risk mitigation as part of the process.
We like our freedom to contract here in the UK. We also, in our polite British way, don't like people telling us what to do. However, as a country, we really like clinical research and want to be at the top of our game, so we don't want a little thing like a contract to hold us back.
The Integrated Research Application System (IRAS), is a freely accessible website containing some useful precedents for clinical trial agreements and related documents. The templates were negotiated between the public and private sector and are intended to set the contracting standard for UK clinical trials.
Even if you do not love them, or you feel certain improvements could be made, it is clearly a great effort to be pragmatic and reasonable and avoid contract negotiations causing delays to important research.
Negotiations and risk
If a business is seeking to be the sponsor of clinical research in the UK involving the NHS in any way, these are normally the templates that will be proposed. The expectation is that the business will assist with the finalisation of the agreement, which might involve removing sections that are not relevant and filling in details where indicated in the document. However, any requests for substantial changes may cause delays, as they will be escalated to the Health Research Authority (HRA), for consideration and response. The HRA is essentially negotiating on behalf of the NHS, and is likely to be fielding many requests for changes alongside its other roles. In short, unless it is a trial of strategic importance to the UK, you might need to wait a long time for an answer (which is likely to be 'no'). The HRA is, in this way, tasked with streamlining and standardisation of the contracting process, so the reluctance to make changes for individual trials is understandable.
Clinical trial agreements should receive legal review, even if you are unlikely to be able to obtain significant concessions. The initial report from your lawyers may raise similar issues for most trials (focusing on the ways in which the liability, insurance, indemnity, data and intellectual property provisions are not favourable for businesses). However, each trial has a different risk profile, and the next step is to consider what mitigating actions or circumstances may apply and what strategies could be used to de-risk the project. From trial to trial, many of the recommended actions and strategies will be similar too, so it would be possible to collect the lessons from each agreement as you go along.
There are some scenarios in which the clinical trial templates are not required. In those scenarios, it is possible to use an adapted version of the most relevant model agreement or it may be better to start from a different document altogether.
2023 updates
Toward the end of 2023, most of the clinical trial agreement templates were updated to include new costing provisions. These include an unmodifiable financial appendix and finance schedule, which relates to stage 2 of the National Contract Value Review (NCVR) process. The NCVR is a major project for NHS England, that is attempting (successfully according to NHS England and the NIHR) to streamline the commercial negotiations relating to the cost of clinical research. According to NHS England, site specific prices will be generated in the interactive Costing Tool (iCT) and then included in the standard financial appendix - and local modification will not be permitted.
Also in the 2023 updates were new clinical trial agreements for hub and spoke arrangements. In short, the new templates are subcontracts designed for flowing down the obligations of the lead trial site under its agreement with the sponsor. These are very useful agreements, particularly for large-scale trials or rare disease clinical trials that necessarily need to be conducted at multiple sites. Like the head agreement with the lead clinical trial, the expectation is the hub and spoke templates are used unmodified.
Are you planning a clinical trial? Do you need help assessing the risks associated with the UK model contracts? Contact Harry Hamilton Jennings in our Pharmaceuticals and Life Sciences team on 07789 533 122, or complete the form below.