Any ConditionNCT06632678
Patient and Public Involvement (PPI) in Non-pharmacological, Non-commercial Spanish Clinical Trials
An observational study of Any Condition, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 2 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Any Condition
- What is being tested?
- behavior, procedure, diet, exercise, device, education, and any other
- How many people
- 32 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Oct 2024to 9 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy and patients with any disease or condition
Inclusion Criteria: Spanish sponsor; non-commercial sponsor. -
Exclusion Criteria: trials assessing pharmacologic interventions.
-
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University Hospital Fundación Jimenez Diaz
Madrid, 28040
Hospital La Paz
Madrid
About this study
Official title: 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.
Read the 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.
- Conditions
- Any Condition
- Being tested
- behavior, procedure, diet, exercise, device, education, and any other
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavior, procedure, diet, exercise, device, education, and any otherOther
Any type of intervention except pharmacological interventions (drugs, biologicals, genetics)
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and public involvement
Presence of a PPI statement in the published report
Measured: Published report; Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start15 Oct 2024
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Responsible party
- Principal investigator, Rafael Dal-Ré, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Investigators
- Rafael Dal-Ré, MD, PhD, MPH, Principal investigator, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632678
- Sponsor's protocol ID
- IIS-FJD-RDR-2024-001
- Status last verified
- Dec 2024
- First submitted
- 1 Oct 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPI in the Design and Conduct of Non-pharmacological, Non-commercial Spanish Clinical Trials Completed and Published in 2009-2024
- ClinicalTrials.gov ID
- NCT06632678
- Acronym / sponsor ID
- IIS-FJD-RDR-2024-001
- Conditions
- Any Condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy and patients with any disease or condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavior, procedure, diet, exercise, device, education, and any otherAny type of intervention except pharmacological interventions (drugs, biologicals, genetics) | Other | – |
Primary outcome
Patient and public involvement
Time frame: Published report; Day 1
Presence of a PPI statement in the published report
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- 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, 165:106964Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Dal-Ré, MD, PhD, MPH principal investigator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Any Condition, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and public involvement (time frame: Published report; Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.