Clinical Utility

The term clinical utility, although used widely, is ill-defined. It is commonly used as a synonym for studies of clinical effectiveness and/or economic evaluations. The most basic definition of clinical utility refers to an estimation of the respective benefits and risks resulting from test use. Risks and benefits are, at this higher-level perspective, to be seen as encompassing both medical and economic connotations and considerations, even though the discussion of benefits and risks is often restricted to the former.

As health care payers are becoming increasingly cost-conscious, and reimbursement decisions are being more commonly influenced by medical-economic considerations, clinical utility is quickly becoming the overriding consideration with regard to the introduction of a companion or other diagnostic. This adds significantly to the burden of research and development expenses for diagnostic companies since reliable estimates of clinical utility will usually require prospective, controlled studies in which clinical endpoints are reached and where interventions are or are not guided by testing for the biomarker of interest.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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