Broadening trial eligibility to improve accrual and access and to better reflect intended-to-treat populations has been recognized as a priority. Historically, patients with brain metastases have been understudied, because of restrictive eligibility across all phases of clinical trials.

In 2016, after a literature search and series of teleconferences, a multistakeholder workshop was convened. Our working group focused on developing consensus recommendations regarding the inclusion of patients with brain metastases in clinical trials, as part of a broader effort that encompassed minimum age, HIV status, and organ dysfunction. The working group attempted to balance the needs of protecting patient safety, facilitating access to investigational therapies, and ensuring trial integrity. On the basis of input at the workshop, guidelines were further refined and finalized.

The working group identified three key populations: those with treated/stable brain metastases, defined as patients who have received prior therapy for their brain metastases and whose CNS disease is radiographically stable at study entry; those with active brain metastases, defined as new and/or progressive brain metastases at the time of study entry; and those with leptomeningeal disease. In most circumstances, the working group encourages the inclusion of patients with treated/stable brain metastases in clinical trials. A framework of key considerations for patients with active brain metastases was developed. For patients with leptomeningeal disease, inclusion of a separate cohort in both early-phase and later-phase trials is recommended, if CNS activity is anticipated and when relevant to the specific disease type.

Expanding eligibility to be more inclusive of patients with brain metastasis is justified in many cases and may speed the development of effective therapies in this area of high clinical need.

公认的优先事项是扩大审判资格，以提高应计和获取机会，并更好地反映拟治疗的人群。从历史上看，由于在临床试验的所有阶段都有资格入选，因此对脑转移患者的研究不足。

2016年，在进行了文献检索和一系列电话会议之后，召开了多方利益相关者研讨会。我们的工作组专注于就将脑转移患者纳入临床试验制定共识性建议，这是包括最低年龄，HIV感染状况和器官功能障碍在内的更广泛努力的一部分。工作组试图平衡保护患者安全，便利获得研究治疗药物和确保试验完整性的需求。根据讲习班的投入，进一步完善和最后确定了准则。

工作组确定了三个关键人群：患有转移性/稳定脑转移的人群，定义为接受过脑转移的既往治疗且入组时CNS疾病在影像学上稳定的患者。患有活动性脑转移的患者，定义为在进入研究时发生新的和/或进行性脑转移；以及患有软脑膜疾病的人。在大多数情况下，工作组鼓励将经过治疗/稳定的脑转移的患者纳入临床试验。建立了活动性脑转移患者的关键考虑因素的框架。对于患有软脑膜疾病的患者，如果预期中枢神经系统活性并且与特定疾病类型相关，则建议在早期和晚期试验中均包括一个单独的队列。

在许多情况下，有理由扩大资格以更广泛地涵盖脑转移患者，这可能会加速在这一具有高度临床需求的领域中有效疗法的发展。