ArticlePerspectives in clinical research
A comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies.
Article in Perspectives in clinical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary.Trials · 2022Article
- Panoramic quality assessment tool for investigator initiated trials.Frontiers in public health · 2022Article
- Embedding good clinical practice into investigator-initiated studies or trials.Perspectives in clinical researchArticle
- The landscape of biomedical research funding in Brazil: a current overview.International braz j urol : official journal of the Brazilian Society of UrologyReview
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn pharmaceutical industry funded clinical studies (PIS), there is rigorous monitoring to ensure adequate and accurate data documentation. In comparison, the investigator-initiated studies (IIS) often lack in resources and may not follow such quality checks. At present, very limited data on the existing deficiencies in documentation for IIS are available. Hence, the present study assessed data quality in IIS relative to those funded by the industry to identify and address issues in data documentation. MATERIALS AND
methodsWe evaluated records of 1276 participants in 13 studies (5 - industry sponsored and 8 - investigator initiated) conducted during 2009-2015 using a prevalidated checklist. The percentage total scores for overall documentation and general trial-related and patient-specific documents were calculated. The percentage total scores within the patient-specific documents were also calculated and compared. Between-group score analysis was done by Student's
resultsThe mean (standard deviation [SD]) percentage total score for the IIS was 80.96 (13.26) and that for PIS was 98.77 (1.84) (
conclusionQuality of IIS needs to be addressed by greater oversight and periodic quality control assessments.
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Registered trials
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