来源：《自然》
刊登日期：2021年4月28日
超纲词：diabetes，medication，endorsement
Most clinical trials have a list of eligibility criteria that must be met before a participant can enrol. These requirements vary from trial to trial and can be designated by investigators and study sponsors. Criteria are devised to protect the safety of participants, so trials might exclude people who are unwell, older or pregnant. Exclusion criteria might also yield ‘clean’ data — that is, data on people who are more like each other. But it also means that trial participants are less representative of patients.
大多数临床试验都有一系列的资格标准，参与者必须满足这些标准才能加入。这些要求因试验而异，可以由研究人员和研究发起者指定。制定标准是为了保护参与者的安全，因此试验可能会排除身体不适、年龄较大或怀孕的人。排除标准也可能产生“干净的”数据——也就是说，彼此更相似人群的数据。但这也意味着试验参与者对患者的代表性较低。
Too often, the requirements are selected simply because the list of exclusion criteria has become a template, carried forwards without scrutiny from one trial to the next. Restricting eligibility in this way can disproportionately affect groups that are already under-represented in medical research. For example, in the United States, diabetes is more common among Black people than white people, and can lead to reduced kidney function. As a result, trials that exclude people with reduced kidney function could disproportionately exclude Black participants.
很多时候，选择这些要求仅仅是因为排除标准列表已经成为一个模板，在没有仔细检查的情况下从一个试验复制到下一个试验。以这种方式限制资格会不成比例地影响那些在医学研究中代表性不足的群体。例如，在美国，糖尿病在黑人中比在白人中更常见，并且会导致肾功能衰竭。因此，排除肾功能衰竭人群的试验可能会不成比例地排除黑人参与者。
A more systematic, scientific approach to crafting eligibility criteria could help. In a study published on 7 April, researchers studied the electronic medical records of more than 60,000 people in the United States with advanced non-small-cell lung cancer. The team compared the survival outcomes of people who had participated in clinical trials of drugs for this type of cancer and people who would have been excluded from participating in clinical trials but who had taken the same drugs outside the studies. The results showed that if a more-diverse group of people had been allowed to take part in the trials, the overall survival outcomes would have been almost the same — but that the pool of eligible trial participants would have more than doubled.
一种更系统、更科学的方法来制定资格标准可能会有所帮助。在4月7日发表的一项研究中，研究人员研究了美国6万多名晚期非小细胞肺癌患者的电子病例。研究小组比较了参加过治疗这类癌症药物临床试验的人和本来被排除在临床试验之外但在研究之外服用了相同药物的人的生存结果。结果表明，如果允许更多样化的人群参与试验，总体生存结果将几乎相同，但符合条件的试验参与者数量将增加一倍以上。
In a separate study, pharmacologist Donald Harvey at Emory University also showed that the widening of eligibility criteria is beneficial to trials for non-small-cell lung cancer drugs. According to data presented at a 9 April meeting held by Friends of Cancer Research and the American Society of Clinical Oncology, allowing people with cancers and those with impaired kidney function to take part in trials increased the proportion of participants aged 75 or older from 16% to 22%. This is important, because the majority of people with cancer are older, yet older people with cancer are under-represented in clinical trials.
在另一项研究中，埃默里大学的药理学家唐纳德·哈维也表明，扩大资格标准有利于非小细胞肺癌药物的试验。根据癌症研究之友和美国临床肿瘤学会4月9日举行的会议上提供的数据，允许癌症患者和肾功能受损者参加试验，可以使75岁以上的参与者比例从16%增加到22%。这是很重要的，因为大多数癌症患者都是老年人，但老年癌症患者在临床试验中的代表性不足。
The two organizations have been working to re-evaluate commonly used eligibility criteria since 2016. They are recommending guidelines for making science-based decisions about whether people who are taking or have recently taken other medications should be enrolled in studies. Now that clinical-trial investigators, researchers and funders are taking the first steps towards changing standard practice, regulators must show support. In 2020, the FDA issued guidance to clinical-trial designers regarding criteria such as HIV status.
自2016年以来，这两家机构一直在努力重新评估常用的资格标准。他们建议制定指导方针，以便作出基于科学的决定，确定正在服用或最近服用其他药物的人是否应该参加研究。现在临床试验研究员、科研人员和出资人正朝着改变标准做法迈出第一步，监管机构必须表示支持。2020年，FDA对临床试验设计者发布了关于HIV状态等标准的指导。
This is impressive progress, but it is time for the effort to broaden its reach — beyond cancer and beyond the United States. Explicit endorsement from other regulators and trial sponsors could propel the movement internationally, and further analyses of electronic medical records could help to establish which requirements should be kept and which are superfluous for studies of various conditions. Together, these changes could foster trials that are faster and more meaningful for the patients they are ultimately meant to serve.
这是一个了不起的进展，但现在是时候努力扩大它的影响范围——不仅仅是癌症，不仅仅在美国。来自其他监管机构和试验发起者的明确支持可以推动这项运动在国际上发展，并且进一步分析电子病历可以帮助确定哪些要求应该保存，哪些对于各种条件的研究是多余的。这些变化加在一起，可能会促进试验对最终服务的患者更快、更有意义。