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Study Design: Randomized Controlled Trials

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The Epidemiology of Aging

Abstract

Due to the growing need to make clinical decisions based on scientifically valid, standardized and objective grounds, the number of randomized controlled trials (RCTs) has steadily been increasing over the last three decades. RCTs represent the most rigorous study design that is aimed at comparing the effects of different interventions on specific outcomes. Nevertheless, evidence-based medicine still has limited applicability, especially for older adults who are often excluded from clinical trials. Clinical trials in older adults present special challenges with regard to ageism in research, recruitment of high-risk participants, multiple comorbidities and polypharmacy, adherence to the protocol, compliance with the interventions, safety, adverse events reporting and standardization of geriatric-specific outcomes. To provide clear and reliable results for translation into clinical practice, RCTs need to be based on a solid rationale and apply state-of-the-art methodologies. A number of key issues must be considered when planning and conducting RCTs, with special attention given to challenges that are related to the inclusion of older adults in clinical research.

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Abbreviations

ALLHAT:

Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attract Trial

ASPREE:

ASPirin in Reducing Events in the Elderly

CAST:

Cardiac Arrhythmia Suppression Trial

CONSORT:

Consolidated Standards of Reporting Trials

CRT:

Contract Research Organization

DSMB:

Data and Safety Monitoring Board

FDA:

Food and Drug Administration

HERS:

Heart and Estrogen/progestin Replacement Study

HMO:

Health Maintenance Organization

HYVET:

Hypertension in the Very Elderly Trial

IRB:

Institutional Review Board

LIFE:

Lifestyle Interventions and Independence for Elders

MTD:

Maximum Tolerated Dose

PPO:

Preferred Provider Organization

RALES:

Randomized Aldactone Evaluation Study

RCT:

Randomized Controlled Trial

SHEP:

Systolic Hypertension for the Elderly Program

SPPB:

Short Physical Performance Battery

T-Trial:

Testosterone Trials

US:

United States

WHI:

Women’s Health Initiative

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Author information

Authors and Affiliations

  1. Department of Aging and Geriatric Research, Institute on Aging, University of Florida, 1329 SW 16th Street, Room 5161, Gainesville, FL, 32608, 32610-0107, 100107, USA

    Marco Pahor M.D.

  2. Institut du Vieillissement, Université de Toulouse, 37 Allées Jules Guesde, 31000, Toulouse, France

    Matteo Cesari M.D., Ph.D.

Authors
  1. Marco Pahor M.D.
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  2. Matteo Cesari M.D., Ph.D.
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Corresponding author

Correspondence to Marco Pahor M.D. .

Editor information

Editors and Affiliations

  1. , Graduate School of Public Health, University of Pittsburgh, A527 Crabtree Hall, DeSoto Street 130, Pittsburgh, 15261, Pennsylvania, USA

    Anne B. Newman

  2. Graduate School of Public Health, Department of Epidemiology, University of Pittsburgh, DeSoto Street, A510 Crabtree 130, Pittsburgh, 15261, Pennsylvania, USA

    Jane A. Cauley

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© 2012 Springer Science+Business Media Dordrecht

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Pahor, M., Cesari, M. (2012). Study Design: Randomized Controlled Trials. In: Newman, A., Cauley, J. (eds) The Epidemiology of Aging. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-5061-6_3

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