Patient and Public Involvement (PPI) in Non-pharmacological, Non-commercial Spanish Clinical Trials

NCT ID: NCT06632678

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-15

Study Completion Date

2024-12-09

Brief Summary

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Patient and public involvement (PPI) in the design and conduct of clinical trials has been encouraged for many years. Yet, there is no data available describing how many trials sponsored by non-commercial Spanish individuals or organizations have liaised with patients, relatives or caregivers and the public to consider their preferences and values in the design of trials assessing non-pharmacological interventions.

Detailed Description

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This systematic review will be conducted in clinical trial registers that host non-pharmacological trials.

PPI is not an item of the information included on clinical trial registers. Thus, the objective of this study is to describe the percentage of non-pharmacological non-commercial Spanish trials with PPI as reported in published reports. For this reason our interest is on trials that have been completed. The published reports of interest are those that first described main trial results; those describing trial protocols. In the abscence of peer-reviewed reports, preprints will be considered. No other type of reports will be considered as valid source of information.

The study will review the trials (i.e.,interventional studies) conducted in Spain, and completed between September 01, 2009 and September 01, 2024. Five registers will be reviewed: clinicaltrials.gov, ISRCTN, DRKS, REBEC, and ACTRN. It is assumed that most of non-pharmacological non-commercial Spanish-sponsored trials will be registered in these five registers as per the information gathered from a previous study on COVID-19 Spanish non-commercial trials. The published reports of all completed trials from these four registers will be searched on PubMed and Google Scholar by using the trials IDs. Corresponding authors will be contacted only in the case it is impossible to retrieve the article or preprint.

In addition to PPI, and to characterize the trials, several variables will be also captured from the articles such as trial design, number of participants, condition/indication, type of intervention, year of publication, number of citations, citations/year, whether the trial was conducted following the Declaration of Helsinki proisions, whether all authors were non-physicians, and data availability statement. In addition, where was the trial registered. We will also register the Spanish region where the sponsor was located, information that will only be used in case it is deem necessary. In other words, the information to be gathered should be captured from the published reports.

Conditions

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Any Condition

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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behavior, procedure, diet, exercise, device, education, and any other

Any type of intervention except pharmacological interventions (drugs, biologicals, genetics)

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role lead

Responsible Party

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Rafael Dal-Ré

Emeritus investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael Dal-Ré, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Locations

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University Hospital Fundación Jimenez Diaz

Madrid, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Countries

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Spain

Related Links

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https://www.elsevier.es/es-revista-medicina-clinica-2-articulo-patient-public-involvement-in-registered-S0025775325001903

Dal-Ré R, García-Méndez E. Patient and public involvement in registered non-pharmacological non-commercial Spanish trials completed in 2009-2024: A systematic review. Medicina Clinica (Barc) 2025, 165:106964

Other Identifiers

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IIS-FJD-RDR-2024-001

Identifier Type: -

Identifier Source: org_study_id

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