Matches in SemOpenAlex for { <https://semopenalex.org/work/W4377029604> ?p ?o ?g. }
Showing items 1 to 69 of
69
with 100 items per page.
- W4377029604 endingPage "A3" @default.
- W4377029604 startingPage "A3.2" @default.
- W4377029604 abstract "Introduction Due to an increase in multicentric paediatric clinical trials after 2007 following the EU Paediatric Regulation, there has been a substantial increase in the number of feasibility questionnaires (FQ). Paediatric clinical trial conduct has made unique advances through the conect4children (c4c) pan-European network, funded by the Innovative Medicines Initiative (IMI2). We examined the role of a national, centralized coordination center in Belgium to pre-fill feasibility questionnaires and quality control responses from sites. Methods This report describes the 4-year learnings of prefilling and performing quality control for FQ by the Belgian Network representative. Additional information has been included from a broad survey sent to sites in the Belgian Network, of which 13 of the 15 sites have responded. Results PIs are confronted by between 10 to 50 FQ requests per year, each taking at average 60 minutes. The number of redundant questions asked by sponsors is on average 43% of the FQ. Of the 112 completed feasibilities, approximately 82% required quality control adjustments by our national coordinating center. Inconsistencies were primarily found in PIs’ report of experience, number of paediatric studies conducted, recruitment estimates and site qualifications. With a centralized and repetitive collection of FQ, a prefill of 65% of the requested information and potential corrections can be performed. A time reduction of 10 to 46% is estimated when a FQ is facilitated through the national representative. Conclusions The increase in paediatric clinical trials has substantially burdened sites within Belgium. Quality control and adjustments by a national central organization could be beneficial to increase feasibility quality and efficiency." @default.
- W4377029604 created "2023-05-19" @default.
- W4377029604 creator A5002750928 @default.
- W4377029604 creator A5036173636 @default.
- W4377029604 creator A5061152501 @default.
- W4377029604 creator A5067521234 @default.
- W4377029604 creator A5071941414 @default.
- W4377029604 creator A5091974075 @default.
- W4377029604 date "2023-05-18" @default.
- W4377029604 modified "2023-10-16" @default.
- W4377029604 title "9 The flood of study feasibilities and the value of a centralised approach" @default.
- W4377029604 doi "https://doi.org/10.1136/archdischild-2023-esdppp.9" @default.
- W4377029604 hasPublicationYear "2023" @default.
- W4377029604 type Work @default.
- W4377029604 citedByCount "0" @default.
- W4377029604 crossrefType "journal-article" @default.
- W4377029604 hasAuthorship W4377029604A5002750928 @default.
- W4377029604 hasAuthorship W4377029604A5036173636 @default.
- W4377029604 hasAuthorship W4377029604A5061152501 @default.
- W4377029604 hasAuthorship W4377029604A5067521234 @default.
- W4377029604 hasAuthorship W4377029604A5071941414 @default.
- W4377029604 hasAuthorship W4377029604A5091974075 @default.
- W4377029604 hasBestOaLocation W43770296041 @default.
- W4377029604 hasConcept C111472728 @default.
- W4377029604 hasConcept C138885662 @default.
- W4377029604 hasConcept C142724271 @default.
- W4377029604 hasConcept C162324750 @default.
- W4377029604 hasConcept C187212893 @default.
- W4377029604 hasConcept C187736073 @default.
- W4377029604 hasConcept C21547014 @default.
- W4377029604 hasConcept C2775924081 @default.
- W4377029604 hasConcept C2779530757 @default.
- W4377029604 hasConcept C512399662 @default.
- W4377029604 hasConcept C535046627 @default.
- W4377029604 hasConcept C545542383 @default.
- W4377029604 hasConcept C71924100 @default.
- W4377029604 hasConceptScore W4377029604C111472728 @default.
- W4377029604 hasConceptScore W4377029604C138885662 @default.
- W4377029604 hasConceptScore W4377029604C142724271 @default.
- W4377029604 hasConceptScore W4377029604C162324750 @default.
- W4377029604 hasConceptScore W4377029604C187212893 @default.
- W4377029604 hasConceptScore W4377029604C187736073 @default.
- W4377029604 hasConceptScore W4377029604C21547014 @default.
- W4377029604 hasConceptScore W4377029604C2775924081 @default.
- W4377029604 hasConceptScore W4377029604C2779530757 @default.
- W4377029604 hasConceptScore W4377029604C512399662 @default.
- W4377029604 hasConceptScore W4377029604C535046627 @default.
- W4377029604 hasConceptScore W4377029604C545542383 @default.
- W4377029604 hasConceptScore W4377029604C71924100 @default.
- W4377029604 hasIssue "6" @default.
- W4377029604 hasLocation W43770296041 @default.
- W4377029604 hasOpenAccess W4377029604 @default.
- W4377029604 hasPrimaryLocation W43770296041 @default.
- W4377029604 hasRelatedWork W2057926175 @default.
- W4377029604 hasRelatedWork W2136139757 @default.
- W4377029604 hasRelatedWork W2355570285 @default.
- W4377029604 hasRelatedWork W2360095886 @default.
- W4377029604 hasRelatedWork W2374345612 @default.
- W4377029604 hasRelatedWork W2378993438 @default.
- W4377029604 hasRelatedWork W2388346776 @default.
- W4377029604 hasRelatedWork W3031351044 @default.
- W4377029604 hasRelatedWork W4256417145 @default.
- W4377029604 hasRelatedWork W1669019592 @default.
- W4377029604 hasVolume "108" @default.
- W4377029604 isParatext "false" @default.
- W4377029604 isRetracted "false" @default.
- W4377029604 workType "article" @default.