Corporate Enabling of Clinical Research
In early 2017, Irish academic institutions and research funders came together under the Corporate Enabling of Clinical Research (CECR) initiative to identify and address the challenges of sponsoring clinical research studies in the areas of governance, contracts, insurance, operations, financial resources, engagement with the health sector, training and support.
The CECR action plan was based on a gap analysis undertaken by the CECR Steering Group. During the gap analysis, the Steering Group reviewed and assessed the challenges of sponsoring and supporting of clinical research, which helped identify the following gaps/areas for improvement:
- Engagement and cooperation between academic institutions and the health sector in relation to the planning, governance and management of clinical studies.
- Transparency and clarity on roles and responsibilities of academic institutions and hospitals in the governance and conduct of clinical studies.
- The requirement to develop a plan for assessing and managing sponsorship risk and fulling sponsorship responsibilities.
- The requirement for the academic sector and the health sector to develop and agree a national contractual framework for the governance and management of clinical studies.
- The requirement to achieve consistency of contractual approaches across the academic and health sectors.
- The need to agree a more timely and efficient inter-institutional approval pathway for studies and contracts which would enable smoother contracting processes and ensure that clinical studies begin within a reasonable time frame.
- The need to clarify the scope and requirements of the Clinical Indemnity Scheme (CIS) cover and clarify the gaps that need to be filled via commercial insurances.
- The need to adequately fund the resource intensive sponsorship role of academic institutions.
- The need to provide support and training for clinicians engaging in clinical studies.
- The need to recognise the importance of the role played by hospitals in clinical research and reflect it in clinical research governance and resourcing plans.
Methodology and Management of the CECR Initiative
To address the key challenges identified above, an action plan was developed by an overarching Steering Group and delivered by six Working Groups (WGs). Each Working Group (WG) was given a particular area to focus on.
The CECR management structure (represented in the organigram adjacent – Figure 1) included a Steering Group and six WGs namely; Governance and Leadership, Sponsorship and Quality, Insurance, Contracts and Legal, Resourcing of Sponsorship and Clinician Engagement and Support.
The action plan was delivered in the time frame of one year (2018) using a project management approach.
Each WG was responsible to deliver one of the high-level objectives of the action plan. Each WG developed a Work Plan with key deliverables.
The Governance and Leadership WG included all WGs co-chairs and senior management representatives from the organisations involved in the initiative. The WGs role was to monitor and support all WG activities and provide feedback on the WG reports.
The Steering Group was inclusive of all contributors to the initiative and met on a quarterly basis to review the progress of the action plan.
The CECR initiative was hosted by Clinical Research Development Ireland (CRDI).CECR founding members included NUIG, TCD, RCSI, UCC, UCD, UL, HRB, CRDI and Health Research Board Clinical Research Coordination Ireland (HRB CRCI). Representatives from Maynooth University, EI, Cancer Trials Ireland, Mercy University and Beaumont Hospitals, SCA and HSE joined at a later date.
The initiative, including the Steering and the Governance and Leadership WG, was co-chaired by Dr Paola Della Porta of RCSI, Nora Geary of UCC and Prof Pat O’ Mahony of CRDI. Gemma Leacy was employed as CECR project manager.
Overall 67 people participated in the development and implementation of the CECR action plan. They contributed to one or more WG activities and brought expertise ranging from financial, to quality and regulatory affairs, risk management, governance and legal affairs, research support and senior management to individual WGs.