Clinical practice guidelines (CPGs) serve as pivotal frameworks for standardizing evidence-based diagnostic and therapeutic approaches, particularly in the management of diabetes and beyond.^{1, 2} However, the integrity of these guidelines can be compromised by conflicts of interest (COIs).^3-5 Given that current increasing attention from pharmaceutical companies to diabetologists^{6, 7} and large prevalence of diabetes and obesity, proper management of financial COIs is essential for trustworthy diabetes CPGs.¹ Despite the critical nature of this issue, no research has investigated these financial relationships in the Japanese context.

Using a publicly accessible database (https://yenfordocs.jp/) containing personal payments for lecturing, consulting, and manuscript drafting from all pharmaceutical companies affiliated with the Japan Pharmaceutical Manufacturers Association, this study examined personal payments made to all authors for Japanese Clinical Practice Guideline for Diabetes 2019 (JCPGD) developed by the Japan Diabetes Society in 2019.⁸ Descriptive analysis was performed on the payment data extracted from the database between 2016 and 2020.

Among all 135 JCPGD authors, 129 (95.6%) received at least one personal payment for lecturing, consulting, and manuscript drafting from the pharmaceutical companies over the 5 years (Table 1). A total of 19 755 payments, amounting to $23 130 423, were made to the JCPGD authors by the pharmaceutical companies. The median payments per author were $89 955 (interquartile range: $7954–$258 527). More than 74.1% (100 authors), 60.7% (82 authors), and 47.4% (64 authors) received more than $10 000, $50 000, and $100 000 in total payments over the 5 years, respectively. The JCPGD chairperson received $207 889 before the JCPGD publication (2016–2018).

Of 135 authors, 80 (59.3%) self-declared financial COIs with companies between 2016 and 2018. However, the Japan Diabetes Society allowed the CPG authors to omit declaring financial COIs below a certain monetary threshold (eg, 500 000 Japanese yen, equivalent to $4683, or more per year per company for lecturing, honoraria, and drafting compensations). Consequently, 55 (40.7%) authors declared no COIs between 2016 and 2018, although 87.2% (48 out of 55) of these authors received at least some personal payments during the declaration period (2016–2018).

This study examined the size and prevalence of financial conflicts of interest among authors of the JCPGD 2019. Surprisingly, more than 95% of the JCPGD authors received more than $23.1 million in personal payments from pharmaceutical companies. Furthermore, the chairpersons received considerable amounts of personal payments during the guideline development period. The high percentage of JCPGD authors with financial COIs, the chairpersons' receipt of personal payments, and limited COI declarations are clear deviations from current international COI management policies.^{1, 9, 10} However, these findings were consistent with previous research in Japan^11-19 and highlight the urgent need for substantial improvement in COI management strategies among CPG authors in Japan in the field of diabetology and endocrinology.

This study has several limitations. The study design precludes longitudinal analysis, and the focus on a single set of guidelines may not be generalizable to other fields or countries. Additionally, as the payment data were only voluntarily disclosed by companies belonging to the Japan Pharmaceutical Manufacturers Association, there could be unmeasured financial relationships between the JCPGD authors and undisclosed pharmaceutical companies.

临床实践指南 (CPG) 是标准化循证诊断和治疗方法的关键框架，特别是在糖尿病及其他疾病的管理方面。^{1, 2}然而，这些准则的完整性可能会因利益冲突 (COI) 而受到损害。^3-5鉴于目前制药公司对糖尿病专家的关注日益增加^6、7以及糖尿病和肥胖症的广泛流行，适当的财务 COI 管理对于值得信赖的糖尿病 CPG 至关重要。¹尽管这个问题很关键，但还没有研究调查日本背景下的这些财务关系。

本研究使用可公开访问的数据库 (https://yenfordocs.jp/)，其中包含日本药品制造商协会附属所有制药公司的讲座、咨询和稿件起草的个人付款，调查了日本临床试验向所有作者支付的个人付款。日本糖尿病协会于 2019 年制定的《2019 年糖尿病实践指南》(JCPGD)。⁸对 2016 年至 2020 年从数据库中提取的支付数据进行了描述性分析。

在所有 135 名 JCPGD 作者中，有 129 名（95.6%）在过去 5 年内至少收到过一笔来自制药公司的讲座、咨询和稿件起草的个人付款（表 1）。制药公司总共向 JCPGD 作者支付了 19 755 笔款项，金额为 23 130 423 美元。每位作者的平均付款额为 89 955 美元（四分位数范围：7954 美元 - 258 527 美元）。超过 74.1%（100 位作者）、60.7%（82 位作者）和 47.4%（64 位作者）在过去 5 年中收到的总付款分别超过 10 000 美元、50 000 美元和 100 000 美元。 JCPGD 主席在 JCPGD 发布之前（2016-2018 年）收到了 207 889 美元。

在 135 名作者中，有 80 名（59.3%）在 2016 年至 2018 年间自我申报了与公司的财务 COI。然而，日本糖尿病协会允许 CPG 作者省略申报低于特定货币阈值（例如 50 万日元，等值）的财务 COI。每家公司每年 4683 美元或更多（用于演讲、酬金和起草报酬）。因此，55 位（40.7%）作者在 2016 年至 2018 年间宣布没有 COI，尽管这些作者中有 87.2%（55 人中的 48 人）在声明期间（2016-2018 年）至少收到了一些个人付款。

这项研究调查了 2019 年 JCPGD 作者之间经济利益冲突的规模和普遍性。令人惊讶的是，超过 95% 的 JCPGD 作者从制药公司收到了超过 2310 万美元的个人付款。此外，在指南制定期间，主席们还收到了大量个人报酬。 JCPGD 作者中存在财务 COI 的比例很高，主席收取个人付款以及有限的 COI 声明，这些都明显偏离了当前国际 COI 管理政策。^{1, 9, 10}然而，这些发现与日本之前的研究一致^11-19，并强调日本 CPG 作者在糖尿病学和内分泌学领域迫切需要大幅改进 COI 管理策略。

这项研究有几个局限性。研究设计排除了纵向分析，并且对一套指南的关注可能无法推广到其他领域或国家。此外，由于付款数据仅由属于日本药品制造商协会的公司自愿披露，因此 JCPGD 作者与未披露的制药公司之间可能存在无法衡量的财务关系。