美国FDA肿瘤学卓越中心最近启动了一项群体外包试点计划，向科学界请求意见，以便于FDA能够使用汇总的临床试验数据进行研究，并用于机构的监管目的。这一努力建立在FDA发表汇总分析文章的良好记录基础上，以探讨因样本量有限而无法在单一试验中解决的科学问题。研究众包试点测试了一种获取监管科学活动外部输入的新方法，因为根据联邦披露法律和保护在监管申请中提交的不同类型数据的规定，FDA通常无法共享患者层次的数据。在28天的众包活动中，我们收到了29个提交的意见，其中包括一个研究想法，我们正在探索可能的后续步骤。根据我们在这一试点中的经验，我们得出结论，众包是一种有前途的新方法，可以收集外部参与和反馈。我们确定了机会，以增进外部肿瘤学界对通常包括在监管申请中的数据类型的理解，并扩大发表的FDA汇总分析的传播，以帮助未来的药物开发和临床实践。

The FDA Oncology Center of Excellence recently launched a crowdsourcing pilot to request ideas from the scientific community for research questions that FDA could address with pooled analyses of clinical trial data submitted to the agency for regulatory purposes. This effort builds on FDA's track record of publishing pooled analyses to explore scientific questions that cannot be addressed in a single trial due to limited sample size. The research crowdsourcing pilot tested a new approach for obtaining external input on regulatory science activities, because FDA is generally unable to share patient-level data outside of the agency due to federal disclosure laws and regulations protecting different types of data submitted in regulatory applications. We received 29 submissions over the 28-day crowdsourcing campaign, including one research idea that we are exploring for possible follow up. Based on our experience with this pilot, we learned that crowdsourcing is a promising new approach to gather external input and feedback. We identified opportunities to build understanding in the external oncology community about the types of data typically included in regulatory applications and expand dissemination of published FDA pooled analyses to help inform future drug development and clinical practice.