Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement.

Many organizations are developing efforts to increase clinical trial eligibility; yet, several recent publications focused on patients with MDS suggest that many patients with this disease may be excluded from clinical trials unnecessarily.

许多组织正在努力提高临床试验的资格标准；然而，几篇最近关注MDS患者的出版物表明，许多此类疾病患者可能不必要地被排除在临床试验之外。

Clinical trial eligibility should reflect the phase of the study and risks of the agent being studied.

临床试验资格应反映研究阶段和研究药物的风险。

Phase 3 trials should be less restrictive than early-phase trials to represent the real-world population as closely as possible.

III期试验的限制性应比早期试验少，以尽可能接近真实世界的人群。

We hypothesize that many clinical trials, particularly phase 3 trials, have unnecessarily restrictive eligibility criteria.

我们假设许多临床试验，特别是III期试验，具有不必要的限制性入选标准。

This study aims to evaluate the most common eligibility criteria according to phase of trial and to determine whether criteria correspond with drug safety signals.

本研究旨在根据试验阶段评估最常见的入选标准，并确定这些标准是否与药物安全信号相对应。

We identified MDS clinical trials registered on ClinicalTrials.gov from 1 January 2000 to 1 September 2023 and analyzed the eligibility criteria of 191 therapeutic MDS trials.

我们在2000年1月1日至2023年9月1日期间，在ClinicalTrials.gov上注册的骨髓增生异常综合征(MDS)临床试验中进行了识别，并分析了191项治疗性MDS试验的纳入标准。

We found that categorical inclusion and exclusion criteria are remarkably similar in representation across trial phases.

我们发现，在各个试验阶段中，分类的纳入和排除标准在表达上惊人地相似。

Additionally, only 13% of trials are concordant with drug safety signals, suggesting that the eligibility criteria are often arbitrary.

此外，只有13%的试验与药物安全信号一致，这表明资格标准往往是随意的。

On behalf of the icMDS (International Consortium for Myelodysplastic Syndromes), an association of international MDS experts, we provide a position statement on restrictive eligibility criteria for MDS clinical trials that should be avoided with the aim of removing barriers to clinical trial enrollment.

代表国际骨髓增生异常综合征联盟（icMDS），这是一个国际MDS专家的协会，我们提供了一个关于应避免的限制性MDS临床试验资格标准的立场声明，目的是消除临床试验入组的障碍。