An observational study in Any Condition, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Completed at 2 sites in Spain. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Observational
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.
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.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 70 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy and patients with any disease or condition
Inclusion Criteria: Spanish sponsor; non-commercial sponsor. -
Exclusion Criteria: trials assessing pharmacologic interventions.
-
Any type of intervention except pharmacological interventions (drugs, biologicals, genetics)
Patient and public involvement
Presence of a PPI statement in the published report
Time frame: Published report; Day 1
Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz