In 2017, Irish academic institutions and funders came together to identify and address the challenges faced by the academic institutions when sponsoring and managing clinical trials particularly with regard to the areas of governance, contracts and insurance. As a result of this engagement, the project, Corporate Enabling of Clinical Research (CECR), was established and is hosted by CRDI. The rationale for this initiative was the belief that the difficulties experienced by academic institutions would be better addressed in a cooperative manner and with input from all stakeholders across the health sector, academia, funding and regulatory bodies.

 

Aims

  • To find better informed and more effective solutions
  • To deliver a more coordinated and efficient use of resources
  • To enable a more targeted use of funding
  • To better manage risks
  • To deliver greater patient safety and a more agile implementation of studies
  • To deliver clinical research of the highest quality

 

Challenges

A detailed Action Plan was developed, addressing the following challenges:

  • A need for engagement and cooperation between academic institutions and the health sector in relation to the governance, management and planning of clinical research.
  • The requirement to document and understand the responsibilities of the academic sponsor of clinical research and the associated legal, regulatory and governance requirements to enable appropriate support and oversight.
  • The need for transparency and clarity on roles and responsibilities both in the hospital system and in academic institutions when carrying out clinical research.
  • The requirement to achieve consistency of contractual approaches across the academic and health sectors and agree a more timely and efficient interinstitutional approval pathway which enables smoother contracting processes and ensure that clinical studies begin within a reasonable time frame.
  • The requirement for the academic sector to develop and agree, with the health sector, a national contractual framework for the governance and management of clinical research.
  • The need to provide clarity on State indemnity and identify the gaps that need to be filled via commercial insurances.
  • The need to provide support and training for clinicians engaging in clinical research and recognise the importance of the role played by hospitals in clinical research.

 

Expected Outcomes

  • Consistency of contractual approaches across the sector.
  • A cooperation framework between academic institutions and the health sector.
  • An institutional pathway for the sponsorship of clinical studies that defines governance, management and approval requirements.
  • Clarity on and consistent affiliation of indemnity under the Clinical Indemnity Scheme
  • A consistent approach across academic institutions around procurement of commercial insurance.

 

CECR

CECR Co-chairs (left to right): Ms Nora Geary (UCC), Dr Pat O’Mahony (CRDI) and Dr Paola Della Porta (RCSI)

CECR Structure

The CECR initiative is co-chaired by Ms Nora Geary of University College Cork, Dr Paola Della Porta of Royal College of Surgeons Ireland and Prof Pat O ‘Mahony of Clinical Research Development Ireland.

The steering group is made up of all members of the CECR initiative which meets on a quarterly basis. The governance and leadership working group is made up of all the co-chairs of the working groups and senior management from multiple partner organisations.

There are six working groups (WGs), namely, governance and leadership, sponsorship and quality, insurance, contracts and legal, budgets, and clinician engagement, support and development, that have been set up to address the challenges identified. See Figure 1 for details.

 

Stakeholders

The CECR initiative comprises over 65 members from the stakeholder organisations, with expertise ranging from clinical research management and support to quality and regulatory affairs, financial, risk management, governance and legal affairs.

The organisations include the five CRDI partner institutions, NUI Galway, Trinity College Dublin, the Royal College of Surgeons in Ireland, University College Cork and University College Dublin, as well as the University of Limerick, Maynooth University, Clinical Research Development Ireland, HRB CRCI, Health Research Board, State Claims Agency, Willis Towers Watson, Cancer Trials Ireland, Mercy University Hospital, Beaumont Hospital, Health Service Executive, Enterprise Ireland and Science Foundation Ireland.

The partner organisations have contributed financially towards the recruitment of a dedicated project manager, to ensure delivery of the project. Moreover, the partner organisations have made a substantial in-kind contribution with the assignment of key members of their staff to the planning and development of the project and participation in the working group activities.

The project is anticipated to be completed by December 2018. A report on the activities completed, plans that are going to be implemented and review plans post 2018 will be made available.

Any actions left outstanding at the end of the project will be reviewed and recommendations made for their resolution.