HSE and IPHA announce the CRO-mCTA, a significant development to improve Ireland’s clinical trial footprint
The HSE and the Irish Pharmaceutical Healthcare Association (IPHA) wishes to improve Ireland’s clinical trial footprint and today they announce a significant development to achieve that aim – the CRO-mCTA.
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.
Both institutions 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 (the Clinical Trial Agreement [CTA]) for clinical trials that involve Contract Research Organisations (CROs), that is convention in a number of other EU countries.
Until now, there have been various slightly different versions of those CRO CTAs, each of which underwent review, costing hospitals money and delaying clinical trial start-up. Provision of a single standard CRO 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 HSE&IPHA has agreed a standard (model) CRO CTA for use between the Site, the CRO and the Sponsor. The HSE&IPHA CRO model CTA (CRO-mCTA) has been reviewed extensively by a subgroup of CROs, IPHA member companies, the HSE and other stakeholders dedicated to developing a fair and balanced standardised document. The key to the success of the new CRO-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 the hospitals, CROs and companies. 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 CRO-mCTA is standardised and therefore changes to the standard text in the document are not permissible. It must be used for any mCTA contract negotiations with CROs commenced after 20.05.24. However, if discussions have already commenced on a CTA before 20.05.24 then the CROmCTA will not be mandatory.
Dr Rebecca Cramp, Director of Code and Regulatory Affairs at IPHA stated that ‘We are pleased to announce the removal of a significant roadblock that negatively affected the conduct of clinical trials in Ireland. Today’s announcement represents the result of forward thinking by our government, close collaboration between IPHA and the HSE and dedication by all to a difficult to achieve outcome. Today’s roll out of the CRO-mCTA will reduce costs, decrease the administrative burden on hospitals and significantly increase the speed at which patients can get lifesaving interventions’.
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