The primary purposes of eligibility criteria are to protect the safety of trial participants and define the trial population. Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardize the generalizability of results, and limit understanding of the intervention’s benefit-risk profile.

ASCO, Friends of Cancer Research, and the US Food and Drug Administration examined specific eligibility criteria (ie, brain metastases, minimum age, HIV infection, and organ dysfunction and prior and concurrent malignancies) to determine whether to modify definitions to extend trials to a broader population. Working groups developed consensus recommendations based on review of evidence, consideration of the patient population, and consultation with the research community.

Patients with treated or clinically stable brain metastases should be routinely included in trials and only excluded if there is compelling rationale. In initial dose-finding trials, pediatric-specific cohorts should be included based on strong scientific rationale for benefit. Later phase trials in diseases that span adult and pediatric populations should include patients older than age 12 years. HIV-infected patients who are healthy and have low risk of AIDS-related outcomes should be included absent specific rationale for exclusion. Renal function criteria should enable liberal creatinine clearance, unless the investigational agent involves renal excretion. Patients with prior or concurrent malignancies should be included, especially when the risk of the malignancy interfering with either safety or efficacy endpoints is very low.

To maximize generalizability of results, trial enrollment criteria should strive for inclusiveness. Rationale for excluding patients should be clearly articulated and reflect expected toxicities associated with the therapy under investigation.

资格标准的主要目的是保护试验参与者的安全并定义试验人群。过多或过于严格的资格标准可能会减慢试验的进度，损害结果的可推广性，并限制对干预措施的利益风险特征的了解。

ASCO，癌症研究之友和美国食品药品监督管理局检查了特定的资格标准（即脑转移，最低年龄，HIV感染，器官功能障碍以及既往和同时发生的恶性肿瘤），以确定是否修改定义以将试验扩展至更广泛的人口。工作组根据证据的审查，对患者群体的考虑以及与研究团体的协商，制定了共识性建议。

治疗或临床上稳定的脑转移患者应常规纳入试验，只有在有充分理由的情况下才应排除在外。在最初的剂量寻找试验中，应基于有益的强大科学依据，纳入儿科特定人群。在涉及成人和儿童人群的疾病的后期试验中，应包括12岁以上的患者。如果没有排除的特殊理由，应将健康且感染艾滋病毒相关风险低的受艾滋病毒感染的患者包括在内。除非研究药物涉及肾脏排泄，否则肾功能标准应可实现广泛的肌酐清除。既往有恶性肿瘤或并发恶性肿瘤的患者也应包括在内，特别是当恶性肿瘤干扰安全性或有效性终点的风险非常低时。

为了最大程度地提高结果的可概括性，试验入学标准应争取包容性。应明确阐明排除患者的理由，并反映与研究中的疗法有关的预期毒性。