At its meeting Thu 5 June 2018, MSD Finance, Research & General Purposes (FRGPC) agreed the following:
- Research Services will no longer submit grant applications for clinical trials where the budgets do not incorporate costs to enable the trial to be adequately supported through a named CTU.
- The University will no longer accept Sponsorship of a Clinical Trial of an Investigational Medicinal Product (CTIMP) which is not fully managed by a UKCRC accredited Oxford CTU.
- A charge will be levied on spin-out and other commercial companies, to cover any work and responsibilities taken on by CTRG and other Research services teams
These decisions were agreed for various reasons, further details of which can be found below.
Embedding Trials in Clinical Trials Units (CTU)
It has been noted that trials conducted by PIs (‘lone PIs’ who are not embedded in CTUs) are often under-resourced and underfunded, as there is limited understanding of what is involved in administering a CTIMP or what costs need to be included in the grant. This poses a considerable drain on CTRG resources, at the expense of other activity, and carries a reputational risk both to the PI and the University. In order to achieve compliance with the regulations, CTRG are required to provide often extensive Clinical Research Organisation (CRO) services, free of charge, to support these PIs, and it has become clear that this level of activity is not sustainable given current resources.
If such PIs were required to prepare and conduct their trial within an established Clinical Trials Unit (CTU), the trials would be costed appropriately and the specialist resource within the CTU would be used to support the PI, allowing CTRG resource to be concentrated on appropriate review and Sponsor oversight.
A possible solution would be that a generic CTU be established, something Oxford currently doesn’t have (our CTUs are discipline or therapy specific), in order that PIs can undertake trial work outside the scope of our current CTUs.
In the meantime, the committee requires that all new CTIMP activity should take place within an accredited unit, noting the need for a period of transition given active trials and subject to further discussions regarding the implications for those Oxford CTUs that are not currently UKCRC accredited
Sponsorship of trials conducted by University Spin-outs (and some other commercial entities)
There are increasing requests for sponsorship by the University for clinical trials that are at least in part funded by Oxford spin-out companies or, sometimes, other companies. It was proposed, and the committee supported, that a fee should be charged to spin outs (or other commercial entity) for Sponsorship and the associated CTRG functions. Exact requirements (and thus fees) would vary by trial and by clinical trial experience within the company.