Twenty years of participation of racialised groups in type 2 diabetes randomised clinical trials: a meta-epidemiological review,Diabetologia

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Twenty years of participation of racialised groups in type 2 diabetes randomised clinical trials: a meta-epidemiological review
Diabetologia ( IF 8.2 ) Pub Date : 2024-01-04 , DOI: 10.1007/s00125-023-06052-w
Rabeeyah Ahmed , Russell J. de Souza , Vincent Li , Laura Banfield , Sonia S. Anand

Aims/hypothesis

Type 2 diabetes mellitus prevalence is increasing globally and the greatest burden is borne by racialised people. However, there are concerns that the enrolment of racialised people into RCTs is limited, resulting in a lack of ethnic and racial diversity. This may differ depending whether an RCT is government funded or industry funded. The aim of this study was to review the proportions of racialised and white participants included in large RCTs of type 2 diabetes pharmacotherapies relative to the disease burden of type 2 diabetes in these groups.

Methods

The Ovid MEDLINE database was searched from 1 January 2000 to 31 December 2020. English language reports of RCTs of type 2 diabetes pharmacotherapies published in select medical journals were included. Studies were included in this review if they had a sample size of at least 100 participants and all participants were adults with type 2 diabetes. Industry-funded trials must have recruited participants from at least two countries. Government-funded trials were not held to the same standard because they are typically conducted in a single country. Data including the numbers and proportions of participants by ethnicity and race were extracted from trial reports. The participation-to-prevalence ratio (PPR) was calculated for each trial by dividing the percentage of white and racialised participants in each trial by the percentage of white and racialised participants with type 2 diabetes, respectively, for the regions of recruitment. A random-effects meta-analysis was used to generate the pooled PPRs and 95% CIs across study types. A PPR <0.80 indicates under-representation and a PPR >1.20 indicates over-representation. Risk of bias assessments were not conducted for this study as the objective was to examine recruitment of racialised and white participants rather than evaluate the trustworthiness of clinical trial outcomes.

Results

A total of 83 trials were included, involving 283,122 participants, of which 15 were government-funded and 68 were industry-funded trials. In government-funded trials, the PPR for white participants was 1.11 (95% CI 0.99, 1.24) and the PPR for racialised participants was 0.72 (95% CI 0.60, 0.86). In industry-funded trials, the PPR for white participants was 1.95 (95% CI 1.74, 2.18) and the PPR for racialised participants was 0.36 (95% CI 0.32, 0.42). The limitations of this study include the reliance on investigator-reported ethnicity and race to classify participants as ‘white’ or ‘racialised’, the use of estimates for type 2 diabetes prevalence and demographic data, and the high levels of heterogeneity of pooled estimates. However, despite these limitations, the results were consistent with respect to direction.

Conclusions/interpretation

Racialised participants are under-represented in government- and industry-funded type 2 diabetes trials. Strategies to improve recruitment and enrolment of racialised participants into RCTs should be developed.

Registration

Open Science Framework registration no. f59mk (https://osf.io/f59mk)

Funding

The authors received no financial support for this research or authorship of the article.

Graphical Abstract

中文翻译：

种族群体参与 2 型糖尿病随机临床试验二十年：荟萃流行病学回顾

目标/假设

全球 2 型糖尿病患病率正在上升，而最大的负担是由种族人群承担的。然而，有人担心纳入随机对照试验的少数族裔人群有限，导致缺乏族裔和种族多样性。这可能会有所不同，具体取决于随机对照试验是由政府资助还是由行业资助。本研究的目的是回顾 2 型糖尿病药物治疗的大型随机对照试验中纳入的种族和白人参与者的比例相对于这些群体中 2 型糖尿病的疾病负担。

方法

Ovid MEDLINE 数据库的检索时间为2000年1月1日至2020年12月31日。其中包括在选定的医学期刊上发表的2型糖尿病药物治疗随机对照试验的英文报告。如果研究的样本量至少为 100 名参与者，并且所有参与者均为患有 2 型糖尿病的成年人，则研究将纳入本次综述。行业资助的试验必须至少招募来自两个国家的参与者。政府资助的试验没有遵循相同的标准，因为它们通常是在一个国家进行的。从试验报告中提取了包括按种族和种族划分的参与者数量和比例的数据。每项试验的参与患病率 (PPR) 是通过将每项试验中白人和种族参与者的百分比分别除以招募地区的白人和种族参与者患有 2 型糖尿病的百分比来计算的。使用随机效应荟萃分析来生成跨研究类型的汇总 PPR 和 95% CI。PPR <0.80 表示代表性不足，PPR >1.20 表示代表性过高。本研究没有进行偏倚风险评估，因为目的是检查种族和白人参与者的招募，而不是评估临床试验结果的可信度。

结果

总共纳入了 83 项试验，涉及 283,122 名参与者，其中 15 项是政府资助的试验，68 项是行业资助的试验。在政府资助的试验中，白人参与者的 PPR 为 1.11（95% CI 0.99，1.24），种族参与者的 PPR 为 0.72（95% CI 0.60，0.86）。在行业资助的试验中，白人参与者的 PPR 为 1.95（95% CI 1.74，2.18），种族参与者的 PPR 为 0.36（95% CI 0.32，0.42）。这项研究的局限性包括依赖研究者报告的种族和种族来将参与者分类为“白人”或“种族化”、使用 2 型糖尿病患病率和人口数据的估计值，以及汇总估计值的高度异质性。然而，尽管存在这些限制，结果在方向上是一致的。