BMC Med Inform Decis Mak - Evaluating genomic tests from bench to bedside: a practical framework.

Tópicos

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{ concept(1167) ontolog(924) domain(897) }
{ framework(1458) process(801) describ(734) }
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Resumo

The development of genomic tests is one of the most significant technological advances in medical testing in recent decades. As these tests become increasingly available, so does the need for a pragmatic framework to evaluate the evidence base and evidence gaps in order to facilitate informed decision-making. In this article we describe such a framework that can provide a common language and benchmarks for different stakeholders of genomic testing. Each stakeholder can use this framework to specify their respective thresholds for decision-making, depending on their perspective and particular needs. This framework is applicable across a broad range of test applications and can be helpful in the application and communication of a regulatory science for genomic testing. Our framework builds upon existing work and incorporates principles familiar to researchers involved in medical testing (both diagnostic and prognostic) generally, as well as those involved in genomic testing. This framework is organized around six phases in the development of genomic tests beginning with marker identification and ending with population impact, and highlights the important knowledge gaps that need to be filled in establishing the clinical relevance of a test. Our framework focuses on the clinical appropriateness of the four main dimensions of test research questions (population/setting, intervention/index test, comparators/reference test, and outcomes) rather than prescribing a hierarchy of study designs that should be used to address each phase.

Resumo Limpo

develop genom test one signific technolog advanc medic test recent decad test becom increas avail need pragmat framework evalu evid base evid gap order facilit inform decisionmak articl describ framework can provid common languag benchmark differ stakehold genom test stakehold can use framework specifi respect threshold decisionmak depend perspect particular need framework applic across broad rang test applic can help applic communic regulatori scienc genom test framework build upon exist work incorpor principl familiar research involv medic test diagnost prognost general well involv genom test framework organ around six phase develop genom test begin marker identif end popul impact highlight import knowledg gap need fill establish clinic relev test framework focus clinic appropri four main dimens test research question populationset interventionindex test comparatorsrefer test outcom rather prescrib hierarchi studi design use address phase

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