At its meeting on Tuesday 23 November 2021, MSD Finance, Research & General Purposes Committee (FRGPC) noted the urgent need to establish a process for prioritisation of studies and amendments submitted to the Research Governance, Ethics & Assurance (RGEA) team for sponsorship approval. This approach will have implications for when some studies and amendments can be considered by RGEA.
The volume of clinical research sponsorship activity is unprecedented, driven by the high number of ongoing and new COVID studies, restart of studies paused during the pandemic, and the commencement of new, non-COVID studies. COVID studies in particular are typically large, complex, urgent (and high profile) and associated with a significantly greater number and complexity of study amendments. Capacity within the RGEA team to support these activities and fulfil its responsibilities as study sponsor is under extreme and unsustainable pressure.
An ‘RGEA Prioritisation Group’ has been created, with key representation from Research Services and MSD. Membership currently includes:
- Deputy Head (Translation & Personnel), Medical Sciences Division
- Deputy Head (Research), Medical Sciences Division
- Executive Director, Research Services
- academic representatives of the University’s registered clinical trials units
- senior members of RGEA
In the short term (until at least March 2022), this group will determine which studies can be considered for sponsorship review at the present time, and the order of prioritisation by study type that will be applied. This will set expectations for clinical investigators and enable finite RGEA resources to be prioritised accordingly (in the context of other pressing business needs).
Studies will be prioritised as follows:
- studies and amendments that have already been submitted for sponsorship review
- existing studies that have subsequent amendments
- investigator-led new studies
- studies initiated and funded by a commercial party, including studies where sponsorship by the commercial party can also be considered
The prioritisation group will have some discretion to deviate from this priority order, when taking scientific and public health priorities into account.
The steps outlined above must be viewed in the light of the current situation and may need to be adapted in response to national or global pressures.
In the medium to longer term, this prioritisation group will also work to establish a more scalable and sustainable position with respect to sponsorship of clinical trials.