A new model clinical trial agreement – the good, the bad and (in its current form) the ugly

26.06.2024

Introduction

The NHS’ Health Research Authority (HRA) recently published its draft template Investigator Initiated Study Agreement (IIS Agreement)1 and called for comments on the draft.

According to the HRA, and in a similar way to the other model agreements used for other types of clinical trials conducted in the UK, the IIS Agreement is intended to act as a “standard contract agreement template” for use between non-commercial sponsors and commercial organisations providing support for investigator-initiated studies.

In principle, this is good news for the UK life sciences community.  Investigator-initiated studies are commonly seen in the industry.  However, to date, there is no model agreement for these type of studies conducted in the UK.  Model agreements for other types of clinical trials in the UK have been around for a while and are generally seen as having a positive effect on short circuiting negotiations and assisting those navigating the complex world of clinical trials. Indeed, we regularly advise clients seeking to put in place bespoke agreements to cover investigator-initiated studies – and, in our opinion, a balanced, and well-drafted, model agreement would be broadly welcomed by both biotech/pharma companies and non-commercial sponsors.

Investigator-initiated studies have many benefits for a pharma/biotech company and not just in terms of cost savings.  These non-biased studies can help enhance the general understanding of medicinal products and their appropriate uses (including, crucially, in terms of product safety) and often result in novel ideas for further research and application2 – all ultimately resulting in improvements to patient care.

For the non-commercial sponsor, in addition to providing the general scientific and patient care benefits described above, investigator-initiated studies enable Principal Investigators (PIs) to enhance their profile in the industry and access clinical products which may otherwise be difficult (or impossible) to access on the open-market.  This ultimately provides PIs with the unique opportunity to generate data and results based on their own clinical experience and expertise.

Therefore, there is no doubt in our mind that a model agreement of this nature is beneficial.  However, unfortunately, the draft IIS Agreement contains a number of significant issues (most notably in terms of IP and data) which, as currently drafted, drastically reduces this benefit.  More concerningly, given that the similar model agreements are intended to be (almost) non-negotiable terms for clinical trials conducted in the UK, without amendment, the draft IIS Agreement is likely to actually deter life sciences companies from entering into such arrangements – which could result in a decline in commercially supported investigator-initiated trials and a loss of the benefits to companies, researchers and, crucially, patients described above.

Continue reading

=======================

[1] https://hra.nhs.uk/about-us/news-updates/call-for-comments-on-new-study-agreement-template/

[2] This is particularly the case where the PI wishes to explore a novel combination of therapies.  See our article on combination therapies more generally for a greater understanding of the key negotiation points between parties for agreements of this nature.