ViewpointA rational framework for decision making by the National Institute For Clinical Excellence (NICE)
Section snippets
Randomised controlled trials as a source of evidence
The importance of the randomised controlled trial as a source of data for decision making is widely accepted. However, for many technologies, such data are few or non-existent. Indeed, no formal licensing process requiring trial data exists for new non-pharmaceutical interventions. As a result, many interventions provided by health services have never been assessed in trials. For example, in the recent NICE appraisal of prophylactic removal of wisdom teeth, only one completed randomised
Decisions
How should organisations such as NICE make decisions despite weak or non-existent evidence from randomised controlled trials? Reimbursement authorities face four possible choices with respect to technologies: adopt the technology on the basis of existing information, adopt now but demand further information to inform this choice in the future, reject on the basis of existing information, or reject and demand further research to inform this choice in the future. An explicit framework is needed
Implications of adopting the new framework
The framework raises a number of issues that will need to be resolved: whether bodies such as NICE have sufficient powers to sustain this form of decision making, and how to prevent disincentives when companies use the evidence generated by those whose product was the first to be commercially released.22 Also, in some circumstances, adoption of a cost-effective technology might have to be delayed until further research has been done. For example, reversal of an initial adoption decision may be
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