IDEAL Policy Initiative

There are abundant opportunities for using IDEAL in device regulation, clinical research, coverage and purchasing policy and health technology assessment.

The most important objective of current IDEAL strategy is to get the Framework and Recommendations implemented in relevant fields of work.

Theoretical constructs which have no practical value tend to atrophy and cannot contribute much to the advancement of science and practice.  There are abundant opportunities for using IDEAL in device regulation, clinical research, coverage and purchasing policy and health technology assessment.

It is also important to analyse empirically examples of IDEAL use, to allow evaluation of its effects in actual practice and to allow modifications to the Framework and Recommendations where these appear necessary.

IDEAL is based on the principles of clinical epidemiology and of medical ethics, but is not in itself an evidence-based construct, having arise through expert consensus (Evidence level 4 or 5).  A programme of evaluation is therefore very important and this in turn requires a pipeline of projects to analyse.

Policy workshop, October 2020

We therefore conducted a Policy Workshop in October 2020 with representatives of the key UK organisations whose work makes IDEAL particularly relevant to them – the Medicines and Healthcare Regulatory Authority (MHRA) the National Institutes for Health Research (NIHR), NICE and the Specialist Commissioning unit within NHS England.

Some of the key conclusions were:

  • IDEAL can assist with evaluation of procedures and devices at a range of levels, in ways which could add value to current processes
  • The levels of adoption considered 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 different levels of adoption vary significantly in cost, viewed as both financial cost and investment of time energy and credibility in re-organising work to accommodate the incorporation of IDEAL.
  • The potential benefits of the different levels of adoption also varied in terms of predicted benefit, in a manner which is the inverse of that seen with cost.

Following the workshop we have worked to follow up on the discussions and seek interactions which might lead to practical projects using IDEAL – which in turn we would hope to use in our empirical analysis of IDEAL strengths and weaknesses.  Progress to the end of March 2021 is as follows:

  • NIHR have made no statement of their intentions and we continue to interact with representatives of their i4i, EME and NTA programmes.
  • NICE have not communicated further
  • The MHRA have expressed interest in further discussions but are not able to comment on their possible future actions or views since they are involved in a wholesale review of their policies and procedures as a result of Brexit.
  • The Accelerated Access Collaborative showed a great deal of interest and have arranged a future meeting with us to discuss how they might consider implementing IDEAL in their work.
  • NHS England have shown considerable interest. The Medical Director, Dr Stephen Powis, attended the meeting and has initiated an interaction with the Policy team and Specialist Commissioning.  We are working with them to produce a proposal for how IDEAL could be incorporated into their work, including a pilot study to begin soon.