ArticleInvestigational new drugs2018
A call for improved transparency in financial aspects of clinical trials: a case study of the CREATE-X trial in the New England Journal of Medicine.
Article in Investigational new drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 8 citations in OpenAlex.
- Increasing trends of pharmaceutical payments to breast cancer specialists in Japan: A retrospective study from 2016 to 2019.PloS one · 2024Article
- International comparison of pharmaceutical industry payment disclosures in the UK and Japan: implications for self-regulation, public regulation, and transparency.Globalization and health · 2023Article
- Prognostic value of using glucosylceramide synthase and cytochrome P450 family 1 subfamily A1 expression levels for patients with triple-negative breast cancer following neoadjuvant chemotherapy.Experimental and therapeutic medicine · 2021Article
- Pharmaceutical payments to certified oncology specialists in Japan in 2016: a retrospective observational cross-sectional analysis.BMJ open · 2019Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction Globally, laws and guidelines for managing conflict of interest are increasingly implemented to achieve transparency in financial ties between physicians and pharmaceutical and medical device industries, yet little information is available regarding the limitations of the current frameworks for disclosing these financial ties. Case In June 2017, the Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X) trial was published in the New England Journal of Medicine. In this study, which suggested the post-surgery addition of capecitabine would improve survival of high-risk breast cancer patients, the cost of capecitabine for off-label use was illegally claimed to the Japanese public health insurance system, rather than being covered by the research budget. This illegal claim led to the profit of more than 100,000,000 JPY (approximately 0.91 million USD) for Chugai Pharmaceutical Company (CPC), which manufactures capecitabine. Additional evidence suggests that the CPC made donations of at least 100,000,000 JPY (approximately 0.91 million USD) and 236,000,000 JPY (approximately 2.1 million USD) to the Japan Breast Cancer Research Group (JBCRG), the study's sponsor and funder where the majority of the Japanese authors served high-level positions, and the Advanced Clinical Research Organization, the other study funder, respectively, during the study period, though the total amount has not been clarified. Neither the CPC's involvement nor its undue profit was mentioned in the published article. Conclusion This case report highlights the lack of financial transparency in the CREATE-X trial, and discusses the potential limitations that may exist in the current frameworks for disclosing financial ties between physicians and relevant industries in clinical trials. Achieving improved transparency is essential to heighten credibility in the findings of clinical trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.