Department of Surgery, Minamisoma Municipal General Hospital, Minamisoma, 2-54-6 Takamicho, Haramachi, Minamisoma, Fukushima, 975-0033, Japan.
Graduate School of Public Health, Teikyo University, Tokyo, 173-8605, Japan.
Invest New Drugs. 2018 Jun;36(3):517-522. doi: 10.1007/s10637-018-0577-x. Epub 2018 Mar 8.
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.
简介
在全球范围内，越来越多的国家制定了法律法规和指导方针来管理利益冲突，以实现医生与制药和医疗器械行业之间财务关系的透明度，但关于当前披露这些财务关系的框架存在的局限性，信息却很少。
案例
2017 年 6 月，《卡培他滨用于残留癌症辅助治疗（CREATE-X）试验》在《新英格兰医学杂志》上发表。在这项研究中，卡培他滨的术后应用被认为可以改善高危乳腺癌患者的生存，卡培他滨的超说明书使用费用被非法申报给日本公共医疗保险系统，而不是由研究预算支付。这一非法申报使生产卡培他滨的中外制药公司（CPC）获利超过 1 亿日元（约合 91 万美元）。此外，有证据表明，CPC 在研究期间向试验的发起者和资助者日本乳腺癌研究集团（JBCRG）和另一个试验资助者先进临床研究组织分别捐赠了至少 1 亿日元（约合 91 万美元）和 2360 万日元（约合 21 万美元），而这些资金的总额尚未明确。尽管如此，在已发表的文章中，既没有提到 CPC 的参与，也没有提到其不当获利。
结论
本病例报告强调了 CREATE-X 试验中财务透明度的缺失，并讨论了当前披露医生与相关行业在临床试验中财务关系的框架可能存在的局限性。提高透明度对于提高临床试验结果的可信度至关重要。
