Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632678
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Patient and Public Involvement PPI in Non-pharmacological Non-commercial Spanish Clinical Trials
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PPI in the Design and Conduct of Non-pharmacological Non-commercial Spanish Clinical Trials Completed and Published in 2009-2024
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 consider their preferences and values in the design of trials assessing non-pharmacological interventions
Detailed Description:
This is a cross-sectional study to 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 ieinterventional studies conducted in Spain and completed between September 01 2009 and September 01 2024 Four registers will be reviewed clinicaltrialsgov ISRCTN DRKS and ACTRN It is assumed that most of non-pharmacological non-commercial Spanish-sponsored trials will be registered in these four registers 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 conditionindication type of intervention year of publication and data availability statement In addition where was the trial register type of sponsor Spanish region where the sponsor is located IPD sharing and whether the results were posted on the register will also be captured
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 ieinterventional studies conducted in Spain and completed between September 01 2009 and September 01 2024 Four registers will be reviewed clinicaltrialsgov ISRCTN DRKS and ACTRN It is assumed that most of non-pharmacological non-commercial Spanish-sponsored trials will be registered in these four registers 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 conditionindication type of intervention year of publication and data availability statement In addition where was the trial register type of sponsor Spanish region where the sponsor is located IPD sharing and whether the results were posted on the register will also be captured
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: