Model Clinical Trial Agreement - IPHA

Model Clinical Trial Agreement

IPHA Model Template Clinical Trial Agreement V2 December 2021_clean

The originator pharmaceutical industry wishes to improve Ireland’s clinical trial footprint. Including patients in clinical trials is critical in developing new innovative treatments and ultimately in improving the nation’s health. There is clear published evidence that by including patients in clinical trials their health will improve substantially. Further, we are of the view that Ireland can play a leading role in the provision of clinical trials in Europe. There is no doubt that Ireland’s decision to join the European Clinical Research Infrastructure Network has the potential to widen our access to clinical research networks in Europe.

There are practical steps we can take here at home to speed up and improve our performance in relation to clinical trials. These include the use of a standardised site contract for clinical trials (the Clinical Trial Agreement* [CTA]) that is convention in a number of other EU countries. Until now, there have been various slightly different CTAs that our members have agreed with the hospitals and other institutions. However, there were endless versions of those CTAs, each of which underwent review, costing money and delaying the trial start. Provision of a single standard CTA for Ireland will reduce delays in hospitals, reduce costs for hospitals and companies, increase efficiencies, enable more trials to set up on time in Ireland and thus, importantly and ultimately, improve patient outcomes.

To that end IPHA has created a standard (model) CTA for use between the Site and the Sponsor. The IPHA model CTA (mCTA) has been reviewed extensively** by an IPHA subgroup of member companies and other stakeholders dedicated to developing a fair and balanced standardised document. The key to the success of the new mCTA is that it is standard and it is the standardisation itself that will speed up the process by reducing the number of rounds of discussion and review for this contract. This will in turn reduce the administrative and financial burden for both the hospitals and members. However, critically it will reduce the time taken to start up clinical trials in Ireland thus improving clinical trial competitiveness and most importantly improving individual patient health.

The mCTA is standardised and therefore changes to the standard text in the document are not permissible. Our members will be using it when they conduct new clinical trials in Ireland. If you have any queries, please do not hesitate to contact directly.

*   This is a Bipartite contract intended to formalise the agreement between the Clinical Trial Site and the Sponsor, thus only the site signature and Sponsor signature is required for this document.

**Process of Extensive Review: The IPHA group that created the sCTA included Colin Thomas (Senior Legal Counsel) & Lisa Ferris (Country Lead Monitor) from Bayer; Patrick Robinson, Senior Legal Council, from Novartis and Sarah Herbert (Snr Site Contract Lead) from BMS. The group was chaired by Myra O’Dwyer, Country Clinical Operations Manager, from Roche.

The group reviewed the Clinical Research Subgroup of the Higher Education Research Contracts Group (CRS HERCG) Template Clinical Trial Agreement for Academic Studies. They mapped this against the needs of our non-academic studies and found that while there was little overlap there were substantial differences. They therefore agreed that IPHA would create a standardised CTA that was very close to, but a standardised version of, the CTAs that our companies already send to hospitals. The IPAH group, therefore, compared and reviewed a variety of CTAs that were already used by various companies and hospitals. They also reviewed templates from other jurisdictions, the GDPR and other local requirements. For each company involved in the team their internal company legal teams also reviewed the various drafts of the sCTA. The entire process took many months, numerous meetings and involved legal input, regulatory input and clinical input. While this is an IPHA initiative a number of groups, including the State Claims Agency and National Office for Research Ethics Committees welcomes and endorses the principle of a standard CTA. The chair of the National Clinical Trial Office (NCTO) has formally welcomed this important initiative by the IPHA and advised that ‘we look forward to working with our industry partners in standardizing to the greatest extent possible the approvals process for setting up international trials in Ireland to the benefit of Irish patients.’

This mCTA has been circulated to the DoH, HSE, HPRA, NREC, State Claims Agency, all Recognised Ethics Committees, the Hospital Group CEOs and IPHA member companies conducting clinical trials in Ireland. Please do not hesitate to circulate it further.