Journal article
Embedding clinical interventions into observational studies
Contemporary clinical trials, Vol.46, pp.100-105
01/2016
DOI: 10.1016/j.cct.2015.11.017
PMCID: PMC5626440
PMID: 26611435
Abstract
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.
Details
- Title: Subtitle
- Embedding clinical interventions into observational studies
- Creators
- Anne B Newman - Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, A527 Crabtree Hall, 130 DeSoto Street, Pittsburgh, PA 15261, USAM. Larissa Avilés-Santa - Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Suite 10018, Bethesda, MD 20892-7936, USAGarnet Anderson - Fred Hutchinson Cancer Research Center, Public Health Sciences Division, 1100 Fairview Ave N, M3-A410, PO Box 19024, Seattle, WA 98109, USAGerardo Heiss - Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 137 E Franklin St, Ste 306, Chapel Hill, NC 27514-3628, USAWm. James Howard - Medstar Health Research Institute, Medstar Washington Hospital Center, Department of Internal Medicine, Rm. 6A 126, 110 Irving St. NW, Washington, DC 20010, USAMitchell Krucoff - Departments of Medicine and Cardiology, Duke University Medical Center, 508 Fulton Street, Room A3006, Durham, NC 27705, USALewis H Kuller - Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, 130 N. Bellefield Avenue, Room 550, Pittsburgh, PA 15213, USACora E Lewis - University of Alabama School of Medicine, Division of Preventive Medicine, Medical Towers 614, 1717 11th Avenue South, Birmingham, AL 35205, USAJennifer G Robinson - Department of Epidemiology, University of Iowa, 145 North Riverside Drive, S455 CPBH, Iowa City, IA 52242, USAHerman Taylor - Jackson Heart Study, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216, USARoberto P Treviño - Social and Health Research Center, 1302 South Saint Mary's Street, San Antonio, TX 78210, USAWilliam Weintraub - Center for Heart & Vascular Health, Christiana Care Health System, 4755 Ogletown-Stanton Road, Suite 1070, Newark, DE 19713, USA
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.46, pp.100-105
- DOI
- 10.1016/j.cct.2015.11.017
- PMID
- 26611435
- PMCID
- PMC5626440
- NLM abbreviation
- Contemp Clin Trials
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Publisher
- Elsevier Inc
- Language
- English
- Date published
- 01/2016
- Academic Unit
- Epidemiology; Internal Medicine
- Record Identifier
- 9983996062102771
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