Standardised Clinical Trial Agreement is an efficiency initiative that will reduce delays in starting trials and improve patient outcomes
A new standardised Clinical Trial Agreement, developed by the Irish Pharmaceutical Healthcare Association (IPHA), is set to significantly improve the clinical research environment.
The Model Clinical Trial Agreement, or mCTA, is an efficiency initiative, led by the originator biopharmaceutical industry, to help Ireland to become a leader in clinical trials in Europe. Clinical trials are used to evaluate the safety and effectiveness of a medicine or a vaccine. A strong clinical research infrastructure gives patients access to sometimes life-saving treatments.
The mCTA will reduce delays in hospitals, cut costs for hospitals and companies, increase efficiencies and enable the faster start of more trials – all aimed at improving patient outcomes.
The originator biopharmaceutical industry has introduced the initiative to accelerate the conduct of clinical trials and increase the number of them carried out in Ireland.
A standardised site contract for clinical trials is convention in several other European Union countries. Until now, there have been various, slightly different clinical trial agreements companies have agreed with the hospitals and other institutions. The multiple versions of these agreements, all them subject to review, cost money and delayed the start of trials.
The mCTA has been reviewed extensively by a subgroup of IPHA member companies and other stakeholders.
Dr Rebecca Cramp, IPHA’s Scientific and Regulatory Affairs Manager, said the mCTA is a reforming contribution by the originator biopharmaceutical industry to Ireland’s clinical research environment.
“The new mCTA standardises the approach to conducting clinical research. Standardisation means speed – the number of rounds of discussion and review for contracts will be reduced. That, in turn, reduces the administrative and financial burden for hospitals and companies. Critically, it cuts the time needed to start clinical trials. That means we can become more competitive in attracting trials to Ireland. In the end, patient outcomes will improve,” said Dr Cramp.
Ireland’s decision to join the European Clinical Research Infrastructure Network has the potential to widen our access to clinical research networks in Europe. IPHA has acknowledged public investment in clinical research over the past decade. The HRB-CRCI feasibility service has, in recent years, helped to process hundreds of clinical trials, with most of them sponsored by originator biopharmaceutical companies. Progress is being made in therapy areas including oncology, haematology, cardiology and respiratory, and infectious diseases.
Since the mCTA is standardised, changes to the standard text in the contract will not be allowed. Companies will use it when they conduct new clinical trials in Ireland. IPHA has written to all major hospitals in Ireland to advise them of the new mCTA.
It can be accessed here.
