Adequacy of Published Oncology Randomized Controlled Trials to Provide Therapeutic Details Needed for Clinical Application
Open accessAbstract
BACKGROUND: Randomized controlled trials (RCTs) improve clinical care through evidence-based results. Guidelines exist for RCT result reporting, but specific details of therapeutic administration promote clinical application and reproduction of the trial design. We assess the reporting methodology in RCTs published in major oncology journals. METHODS: Ten essential elements of RCT reporting were identified and included drug name, dose, route, cycle length, maximum number of cycles, premedication, growth factor support, patient monitoring parameters, and dosing adjustments for hematologic and organ-specific toxicity. All therapy-based oncology RCTs published between 2005 and 2008 in the New England Journal of Medicine (NEJM), Journal of Clinical Oncology (JCO), Journal of the National Cancer Institute (JNCI), Blood, and Cancer were analyzed for inclusion of these 10 elements. RESULTS: Of 339 identified articles, 262 were included in the final analysis (165 from JCO, 31 from NEJM, 27 from Cancer, 20 from JNCI, and 19 from Blood). Premedication, growth factor support, and dose adjustments for toxicities were each reported less than half of the time. Only 30 articles (11%) met the main objective of complete data reporting (ie, all 10 essential elements) and was highest in JNCI (5/20; 25%), followed by Cancer (5/27; 18%), JCO (18/165; 11%), Blood (1/19; 5%), and NEJM (1/31; 3%). The presence of an online appendix did not substantially improve complete reporting. CONCLUSIONS: RCTs published in major oncology journals do not consistently report essential therapeutic details necessary for translation of the trial findings to clinical practice. Potential solutions to improve reporting include modification of submission guidelines, use of online appendices, and providing open access to trial protocols.
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The quality of intervention description in publications is remarkably poor.
“However the quality of intervention description in publications is remarkably poor.”
From Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (2014) · cites this paper as [1]
The Discussion reports insufficient therapeutic detail in 262 phase III oncology RCT publications; only 11% reported all 10 elements assessed. This supports poor intervention reporting in that sample, but not the unqualified claim about publications generally. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe most frequently missing elements were dose-adjustment and pre-medications, but 16% of trials omitted even the route of drug administration.
“The most frequently missing elements were dose-adjustment and pre-medications, but 16% of trials omitted even the route of drug administration.”
From Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (2014) · cites this paper as [1]
A recent analysis found that only 11% of 262 trials of cancer chemotherapy provided complete details of the trial treatments.
“For example, a recent analysis found that only 11% of 262 trials of cancer chemotherapy provided complete details of the trial treatments. 1”
From Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (2014) · cites this paper as [1]
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73rd Congress of the Italian Society of Pediatrics
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- Authors
- Duff, J. M., Leather, H., Walden, E. O., LaPlant, K. D., & George, T. J.
- Affiliations
- University of Florida Health (US)
- Venue
- JNCI: Journal of the National Cancer Institute
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-05-19
- Volume
- 102
- Issue
- 10
- Pages
- 702-705
- ISSN
- 0027-8874 (ISSN-L)
- 1460-2105
- OpenAlex
- W2118828017
- Cited by
- 103
- References
- 14
- Citations by year
- 2026: 2 · 2025: 8 · 2024: 1 · 2023: 4 · 2022: 3 · 2021: 1 · 2020: 2 · 2019: 12 · 2018: 7 · 2017: 10 · 2016: 18 · 2015: 3 · 2014: 9 · 2013: 8 · 2012: 3
- FWCI
- 7.63
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- other-oa
- Locations
- JNCI Journal of the National Cancer Institute (publishedVersion, other-oa)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- trial reporting quality, route of administration, premedication, growth factor support, translation to clinical practice, reporting guidelines
- MeSH terms
- Clinical Protocols, Humans, Medical Oncology, Neoplasms, Periodicals as Topic, Practice Patterns, Physicians', Reproducibility of Results, Randomized Controlled Trials as Topic, Guidelines as Topic, Journalism, Medical, Evidence-Based Medicine, Benchmarking, Access to Information
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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