FDA鼓励无法治愈的癌症患者不管先前的治疗方法，纳入肿瘤学临床试验
Dr. Richard Pazdur at his office at the Food and Drug Administration in Silver Spring, MD.
The following quote is attributed to Richard Pazdur, MD.director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research,“Today, the FDA issued a draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials, regardless of whether they have received existing alternative treatment options. Historically, many clinical trials have required that participating patients previously received multiple therapies. "
FDA 肿瘤学卓越中心主任兼 FDA 药物评价和研究中心肿瘤疾病办公室代理主任 Richard Pazdur 医学博士，”今天FDA 发布了一份指南草案，鼓励将无法治愈的癌症患者（当没有治愈潜力或延长/接近正常生存期）纳入癌症临床试验，无论他们是否接受了现有的替代治疗方案。从历史上看，许多临床试验都要求参与的患者以前接受过多种治疗。“
The FDA believes patients with incurable cancers, if provided adequate information to make an informed decision, should be eligible to participate in oncology clinical trials. If there is no scientific rationale for excluding these patients, then clinical trial eligibility criteria should be broadened to include these patients, with appropriate informed consent.
FDA 认为患有无法治愈的癌症患者，如果提供足够的信息来做出明智的决定，应该有资格参加肿瘤学临床试验。如果排除这些患者没有科学依据，则应扩大临床试验资格标准以包括这些患者，并获得适当的知情同意。
This draft guidance is part of the FDA’s broader initiative to encourage rational expanded patient eligibility for oncology clinical trials.
该指南草案是 FDA 鼓励扩大患者参加肿瘤临床试验资格的更广泛举措的一部分。
The draft guidance, when finalized, will provide sponsors with recommendations regarding including patients who have not received available therapy/therapies, such as evaluating these patients in separate cohorts from patients who have received available therapies.
指南草案最终确定后，将为申办者提供有关纳入尚未接受可用疗法/疗法的患者建议，例如将这些患者与已接受可用疗法的患者分在不同的队列中进行评估。
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-encourages-inclusion-patients-incurable-cancers-oncology-clinical-trials-regardless
（原创）美国希望之光医疗编译，欢迎转载，请注明出处。
