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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| Vydané v: | Value in health Ročník 17; číslo 4; s. 471 - 475 |
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| Hlavní autori: | , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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New York, NY
Elsevier Inc
01.06.2014
Elsevier |
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| ISSN: | 1098-3015, 1524-4733, 1524-4733 |
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| Abstract | 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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| AbstractList | AbstractEvidence 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. 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. Adapted from the source document. 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. 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 pre-specified 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. In order 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. 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.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. |
| Author | Vandigo, Joseph Wicks, Paul Mullins, C. Daniel Zheng, Zhiyuan |
| AuthorAffiliation | 2 PatientsLikeMe Inc., Research & Development, Cambridge, MA, USA 1 University of Maryland School of Pharmacy, Pharmaceutical Health Services Research Department, Baltimore, MD, USA 3 American Cancer Society, Surveillance and Health Services Research Program, Atlanta, GA, USA |
| AuthorAffiliation_xml | – name: 3 American Cancer Society, Surveillance and Health Services Research Program, Atlanta, GA, USA – name: 1 University of Maryland School of Pharmacy, Pharmaceutical Health Services Research Department, Baltimore, MD, USA – name: 2 PatientsLikeMe Inc., Research & Development, Cambridge, MA, USA |
| Author_xml | – sequence: 1 givenname: C. Daniel surname: Mullins fullname: Mullins, C. Daniel organization: Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy, Baltimore, MD, USA – sequence: 2 givenname: Joseph surname: Vandigo fullname: Vandigo, Joseph email: jvandigo@umaryland.edu organization: Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy, Baltimore, MD, USA – sequence: 3 givenname: Zhiyuan surname: Zheng fullname: Zheng, Zhiyuan organization: Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy, Baltimore, MD, USA – sequence: 4 givenname: Paul surname: Wicks fullname: Wicks, Paul organization: PatientsLikeMe, Inc., Research & Development, Cambridge, MA, USA |
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| Copyright | 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2015 INIST-CNRS Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved. 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier 2014 |
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| Keywords | patient-centered adaptive trial design pragmatic Bayesian Patient-centered approach Goal Statistical analysis Clinical trial |
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| SubjectTerms | 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 |
| Title | Patient-Centeredness in the Design of Clinical Trials |
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