The National Institute for Clinical Excellence (NICE) and the Medical Research Council (MRC) have announced a £2 million call for proposals for research into the methods used by NICE to underpin its decision-making.

NICE has “faced a range of challenges” relating to the research methods it uses in producing its guidance for the National Health Service (NHS), says the MRC, which is the UK’s lead organisation for methodology research, while a January 2008 report by the House of Commons Health Select Committee was particularly critical of the Quality Adjusted Life Year (QALY) threshold used by NICE in its assessments, pointing out that this threshold has no scientific basis and is not related to the NHS budget.

Since the MPs’ report, NICE has been working with the MRC to identify its major methodological research priorities, and following this “scoping study” these have now been grouped into five “high level” areas: - analysis and design of effectiveness studies and their synthesis; - synthesis of evidence from patients, the public and stakeholders; - economic analysis and uncertainty; - measurement and valuation of benefits; and - decision-making at NICE.

The study has also found that issues of particular importance to stakeholders include: - capturing new measures into QALY estimation and the use of disease-specific measures in decision-making; - identification of important benefits and “dis benefits” that are, and are not, captured in the QALY approach, and methods for their valuation and use; - methods for synthesising and integrating non-experimental evidence (including from patients) with experimental evidence in the process; - methods for estimation of NICE’s cost-effectiveness threshold; and - establishing optimal methods for collection, analysis, critical appraisal and synthesis of non-experimental evidence disease registers and electronic data sets to enable it to be used in the process.

Announcing the call for proposals, NICE’s clinical and public health director Professor Peter Littlejohns said the Institute is tasked with making some of the most difficult decisions in public life, and it is therefore vital for people to continue to have confidence not just in its guidance, but also in the processes and methods used to produce it. “Of particular importance are the issues around how we measure health-related quality of life. This is translational research - it’s about getting things into our process and methodology that will make a real difference to patients,” he added.

“The transparency of NICE’s decisions means that our methods are constantly under scrutiny and we are constantly pushing methodological frontiers. Although this positions NICE firmly amongst the world leaders in assessing health technologies, it also means we are, to some extent, in uncharted waters. It is right that we are challenged - for example on our cost-effectiveness threshold and how we calculate that – and why, therefore, this research is so important,” said Prof Littlejohns.

The deadline for submitting proposals for the programme is July 22. Although the research needs identified by the study are specific to NICE, they may also have relevance to the needs of other healthcare regulatory agencies and decisionmakers such as the Medicines and Healthcare products Regulatory Agency (MHRA), so applicants should also “consider the utility of their research for other agencies.” say NICE and the MRC.

- Sir Ian Kennedy, emeritus professor of health law, ethics and policy at University College London (UCL), is due to report the findings of his inquiry into how NICE values innovation and other benefits to the Institute’s Board, at its public meeting on July 22.