Patient-Centeredness in the Design of Clinical Trials

Evidence from clinical trials should contribute to informed decision making and a learning health care system. People frequently, however, find participating in clinical trials meaningless or disempowering. Moreover, people often do not incorporate trial results directly into their decision making....

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Bibliographic Details
Published in:Value in health Vol. 17; no. 4; pp. 471 - 475
Main Authors: Mullins, C. Daniel, Vandigo, Joseph, Zheng, Zhiyuan, Wicks, Paul
Format: Journal Article
Language:English
Published: New York, NY Elsevier Inc 01.06.2014
Elsevier
Subjects:
adaptive
Attitudes
Bayes Theorem
Bayesian
Biological and medical sciences
Clinical trials
Clinical Trials as Topic
Decision making
General aspects
Health care
Humans
Internal Medicine
Learning
Medical sciences
Miscellaneous
Patient Participation
patient-centered
Patient-Centered Care
Personnel
Planification. Prevention (methods). Intervention. Evaluation
pragmatic
Public Health
Public health. Hygiene
Public health. Hygiene-occupational medicine
Research Design
trial design
patient-centered
adaptive
trial design
pragmatic
Bayesian
Patient-centered approach
Goal
Statistical analysis
Clinical trial
ISSN:1098-3015, 1524-4733, 1524-4733
Online Access:Get full text
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Summary:Evidence from clinical trials should contribute to informed decision making and a learning health care system. People frequently, however, find participating in clinical trials meaningless or disempowering. Moreover, people often do not incorporate trial results directly into their decision making. The lack of patient centeredness in clinical trials may be partially addressed through trial design. For example, Bayesian adaptive trials designed to adjust in a prespecified manner to changes in clinical practice could motivate people and their health care providers to view clinical trials as more applicable to real-world clinical decisions. The way in which clinical trials are designed can transform the evidence generation process to be more patient centered, providing people with an incentive to participate or continue participating in clinical trials. To achieve the transformation to patient-centeredness in clinical trial decisions, however, there is a need for transparent and reliable methods and education of trial investigators and site personnel.
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ISSN:1098-3015
1524-4733
1524-4733
DOI:10.1016/j.jval.2014.02.012