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Patient involvement in clinical research: why, when, and how

Authors Sacristan JA, Aguaron A, Avendaño C, Garrido P, Carrion J, Gutierrez A, Kroes R, Flores A

Received 14 January 2016

Accepted for publication 17 February 2016

Published 27 April 2016 Volume 2016:10 Pages 631—640

DOI https://doi.org/10.2147/PPA.S104259

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Colin Mak

Peer reviewer comments 2

Editor who approved publication: Dr Johnny Chen


José A Sacristán,1 Alfonso Aguarón,2 Cristina Avendaño-Solá,3 Pilar Garrido,4 Juan Carrión,5 Alipio Gutiérrez,6 Robert Kroes,7 Angeles Flores1

1Medical Department, Lilly Spain, 2Myeloma Patients Europe, 3Research Ethics Committee, University Hospital Puerta de Hierro, 4Oncology Department, Hospital Ramón y Cajal, 5FEDER (Spanish Federation for Rare Diseases), 6National Association of Health Journalists, Madrid, Spain; 7Clinical Open Innovation, Lilly Europe, Amsterdam, the Netherlands

Abstract: The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1) setting priorities, 2) study leadership and design, 3) improved access to clinical trials, 4) preparation and oversight of the information provided to participants, 5) post-study evaluation of the patient experience, and 6) the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient.

Keywords: patients, research, clinical trials, bioethics, engagement

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