Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications
Open accessAbstract
Objective To investigate to what extent three types of documents for reporting clinical trials provide sufficient information for trial evaluation. Design Retrospective analysis Data sources Primary studies and corresponding documents (registry reports, clinical study reports, journal publications) from 16 health technology assessments of drugs conducted by the German Institute for Quality and Efficiency in Health Care between 2006 and February 2011. Data analysis We assessed reporting quality for each study and each available document for six items on methods and six on outcomes, and dichotomised them as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of studies with complete reporting for methods and outcomes, per item and overall, and compared the findings. Results We identified 268 studies. Publications, study reports and registry reports were available for 192 (72%), 101 (38%), and 78 (29%) studies, respectively. Reporting quality was highest in study reports, which overall provided complete information for 90% of items (1086/1212). Registry reports provided more complete information on outcomes than on methods (overall 330/468 (71%) v 147/468 (31%)); the same applied to publications (594/1152 (52%) v 458/1152 (40%)). In the matched pairs analysis, reporting quality was poorer in registry reports than in study reports for overall methods and outcomes (P Conclusion Registry reports and publications insufficiently repo…
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High quality protocols and statistical analysis plans contain relevant information on study design and conduct that is often not reported in journal publications or trial registries.
“High quality protocols and statistical analysis plans contain relevant information on study design and conduct that is often not reported in journal publications or trial registries.79 80”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [80]
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Self-citation
- Authors
- Wieseler, B., Kerekes, M. F., Vervoelgyi, V., McGauran, N., & Kaiser, T.
- Affiliations
- Institute for Quality and Efficiency in Health Care (DE)
- Corresponding author
- Wieseler, B.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2012-01-03
- Volume
- 344
- Issue
- jan03 1
- Pages
- d8141-d8141
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- OpenAlex
- W2051457518
- Cited by
- 129
- References
- 37
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 4 · 2023: 6 · 2022: 7 · 2021: 31 · 2020: 16 · 2019: 6 · 2018: 8 · 2017: 7 · 2016: 7 · 2015: 12 · 2014: 8 · 2013: 7 · 2012: 6
- FWCI
- 12.05
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- trial reporting quality, clinical study reports, journal publishing, health technology assessment, drug trials, reporting guidelines
- MeSH terms
- Drug Evaluation, Periodicals as Topic, Registries, Retrospective Studies, Randomized Controlled Trials as Topic, Research Report
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