IDEAL Virtual Policy Workshop: Monday 19th October 2020
This workshop was held to explore the potential usefulness of IDEAL to UK government organisations which deal with the scientific evaluation of safety and effectiveness of medical treatment. The meeting was supported by funding from UKRI, Research England and the University of Oxford’s QR fund.
Representatives attended from the four government organisations with a major role in evaluation in this area (MHRA, NICE, NHS England Clinical Commissioning and NIHR) and also from the medical device industry.
Five working groups were formed, based on these major stakeholders. Groups were facilitated by members of the IDEAL Collaboration and met online several times before the plenary conference. The four organisation-based groups were each asked to produce a consensus report on the feasibility and desirability of integrating IDEAL into their organisations’ infrastructure for evaluation or (in the case of NIHR) creation of clinical evidence. The industry group were asked to critique the work of the four organisations in their current state, and consider whether their fitness for purpose could be enhanced by integration of IDEAL.
Proposals from the IDEAL Collaboration suggested several ways of integrating IDEAL into infrastructure, with the potential for benefit roughly correlating with the cost of implementing them in terms of finance, human resources and organisational change required. These were:
- Level 1: Adopting the language of IDEAL to identify and describe innovations, evaluations and likely evidence gaps
- Level 2: Recommending IDEAL as a useful framework for designing research (providing tools)
- Level 3: Requiring evidence which addresses key IDEAL Stage questions
- Level 4: Linking staged approval to staged evidence production, using IDEAL to guide process
The industry group indicated that using IDEAL as a common language shared by NICE, MHRA and Commissioners to describe treatments and their stage of evolution, and the study types used to evaluate them would be welcome They recognised that IDEAL could help identify research needs at different stages in the device life cycle. It would help industry if all three government bodies whose approval they would need approved and accepted IDEAL format studies, so that evidence could be “produced once and used often”. They emphasised also that evidence requirements need to be tailored to the risk profile of the device.
The four working groups based on organisations all saw the arguments for integrating IDEAL into their systems, and agreed there was a potential benefit to varying degrees. The MHRA were constrained by their ongoing development of an entirely new UK-specific approval system for devices, which prevented them from commenting in a range of areas, but engaged positively in discussion about the potential benefits of more standardised set of guidelines for studies to support approval applications. The NHS Commissioning group was very positive about the potential for IDEAL to be integrated into their work and suggested further contacts to explore this. NICE were interested in the possibility of using IDEAL as a common language, but were more cautious about other measures, arguing that their current systems appeared to be functioning well and had received widespread approval. The NIHR group considered that IDEAL had great potential and set out a series of practical steps which could help ensure it is used more in research. These included encouraging funding and scientific boards within the NIHR programmes to use IDEAL language when discussing studies of complex interventions and promoting the use of IDEAL pilot studies leading on to RCTs.
The meeting closed with an agreement that IDEAL would follow up with each stakeholder group to explore whether there were specific opportunities for change which they wished to discuss further.
Read the full report here: IDEAL Policy Workshop Report Oct 2020 FInal