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

PPI in the Design and Conduct of Non-pharmacological, Non-commercial Spanish Clinical Trials Completed and Published in 2009-2024

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.

Study Overview

• Status: Completed
• Conditions: Any Condition
• Intervention / Treatment: Other: behavior, procedure, diet, exercise, device, education, and any other

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital La Paz
  • Madrid, Spain, 28040
    • University Hospital Fundación Jiménez Díaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy and patients with any disease or condition

Description

Inclusion Criteria: Spanish sponsor; non-commercial sponsor. -

Exclusion Criteria: trials assessing pharmacologic interventions.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and public involvement	Presence of a PPI statement in the published report	Published report; Day 1

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Collaborators: Hospital Universitario La Paz
• Investigators: Principal Investigator: Rafael Dal-Re, MD, PhD, MPH, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): December 9, 2024
• Study Completion (Actual): December 9, 2024

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IIS-FJD-RDR-2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO