title: Embedding clinical interventions into observational studies.
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.
authors.affiliation: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, A527 Crabtree Hall, 130 DeSoto Street, Pittsburgh, PA 15261, USA. Electronic address: newmana@edc.pitt.edu.
authors.forename: Anne B
authors.initials: AB
authors.lastname: Newman
authors.affiliation: Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Suite 10018, Bethesda, MD 20892-7936, USA. Electronic address: avilessantal@nhlbi.nih.gov.
authors.forename: M Larissa
authors.initials: ML
authors.lastname: Avilés-Santa
authors.affiliation: Fred Hutchinson Cancer Research Center, Public Health Sciences Division, 1100 Fairview Ave N, M3-A410, PO Box 19024, Seattle, WA 98109, USA. Electronic address: garnet@whi.org.
authors.forename: Garnet
authors.initials: G
authors.lastname: Anderson
authors.affiliation: 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, USA. Electronic address: gerardo_heiss@unc.edu.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Heiss
authors.affiliation: Medstar Health Research Institute, Medstar Washington Hospital Center, Department of Internal Medicine, Rm. 6A 126, 110 Irving St. NW, Washington, DC 20010, USA. Electronic address: wm.james.howard@medstar.net.
authors.forename: Wm James
authors.initials: WJ
authors.lastname: Howard
authors.affiliation: Departments of Medicine and Cardiology, Duke University Medical Center, 508 Fulton Street, Room A3006, Durham, NC 27705, USA. Electronic address: mitchell.krucoff@duke.edu.
authors.forename: Mitchell
authors.initials: M
authors.lastname: Krucoff
authors.affiliation: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, 130 N. Bellefield Avenue, Room 550, Pittsburgh, PA 15213, USA. Electronic address: kullerl@edc.pitt.edu.
authors.forename: Lewis H
authors.initials: LH
authors.lastname: Kuller
authors.affiliation: University of Alabama School of Medicine, Division of Preventive Medicine, Medical Towers 614, 1717 11th Avenue South, Birmingham, AL 35205, USA. Electronic address: bethlew@uab.edu.
authors.forename: Cora E
authors.initials: CE
authors.lastname: Lewis
authors.affiliation: Department of Epidemiology, University of Iowa, 145 North Riverside Drive, S455 CPBH, Iowa City, IA 52242, USA. Electronic address: jennifer-g-robinson@uiowa.edu.
authors.forename: Jennifer G
authors.initials: JG
authors.lastname: Robinson
authors.affiliation: Jackson Heart Study, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216, USA. Electronic address: htaylor@umc.edu.
authors.forename: Herman
authors.initials: H
authors.lastname: Taylor
authors.affiliation: Social and Health Research Center, 1302 South Saint Mary's Street, San Antonio, TX 78210, USA. Electronic address: rtrevino@sahrc.org.
authors.forename: Roberto P
authors.initials: RP
authors.lastname: Treviño
authors.affiliation: Center for Heart & Vascular Health, Christiana Care Health System, 4755 Ogletown-Stanton Road, Suite 1070, Newark, DE 19713, USA. Electronic address: wweintraub@christianacare.org.
authors.forename: William
authors.initials: W
authors.lastname: Weintraub
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D016021:Epidemiologic Studies; D006801:Humans; D064887:Observational Studies as Topic / Q000191:economics / Q000379:methods*; D012107:Research Design
keywords: Clinical trial; Cohort; Epidemiology; Hybrid design; Observational study