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Embedding clinical interventions into observational studies.

MedStar author(s):

Citation: Contemporary Clinical Trials. 46:100-5, 2016 Jan.PMID: 26611435Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Clinical Trials as Topic/mt [Methods] | *Epidemiologic Studies | *Observational Studies as Topic/mt [Methods] | Clinical Trials as Topic/ec [Economics] | Cohort Studies | Cost-Benefit Analysis | Humans | Observational Studies as Topic/ec [Economics] | Research DesignYear: 2016 ISSN:

1551-7144

Name of journal: Contemporary clinical trialsAbstract: Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. Copyright (c) 2015. Published by Elsevier Inc.All authors: Anderson G, Aviles-Santa ML, Heiss G, Howard WJ, Krucoff M, Kuller LH, Lewis CE, Newman AB, Robinson JG, Taylor H, Trevino RP, Weintraub WFiscal year: 2016Digital Object Identifier:

http://dx.doi.org/10.1016/j.cct.2015.11.017

Date added to catalog: 2017-03-06

Holdings ( 1 )
Title notes ( 2 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	26611435	Available		26611435

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. Copyright (c) 2015. Published by Elsevier Inc.

English