title: Patient involvement in clinical research: why, when, and how.
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.
authors.affiliation: Medical Department, Lilly Spain, Madrid, Spain.
authors.forename: José A
authors.initials: JA
authors.lastname: Sacristán
authors.affiliation: Myeloma Patients Europe, Madrid, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Aguarón
authors.affiliation: Research Ethics Committee, University Hospital Puerta de Hierro, Madrid, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Avendaño-Solá
authors.affiliation: Oncology Department, Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Garrido
authors.affiliation: FEDER (Spanish Federation for Rare Diseases), Madrid, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Carrión
authors.affiliation: National Association of Health Journalists, Madrid, Spain.
authors.forename: Alipio
authors.initials: A
authors.lastname: Gutiérrez
authors.affiliation: Clinical Open Innovation, Lilly Europe, Amsterdam, the Netherlands.
authors.forename: Robert
authors.initials: R
authors.lastname: Kroes
authors.affiliation: Medical Department, Lilly Spain, Madrid, Spain.
authors.forename: Angeles
authors.initials: A
authors.lastname: Flores
keywords: bioethics; clinical trials; engagement; patients; research