实际世界数据 (RWD) 快速成为解决新型抗癌疗法等新治疗不确定性的重要信息来源。许多利益相关者正在使用这些数据和由此得出的证据来回答监管机构批准后抗肿瘤药物的安全性和有效性方面的问题。我们的目标是调查学术 RWD 研究现状，探讨 RWD 在调查者发起的临床研究中被整合的程度。我们设计了一项在线调查，于2022年5月至8月期间向活跃于欧洲、北美、南美、亚洲和/或大洋洲的癌症合作组织的代表分发。共有125个合作组织参与了此次研究，分布在58个国家，研究覆盖13个不同的癌症领域。尽管大多数回答者(67.2%)没有建立正式的政策来收集和利用 RWD，但大多数(68.0%)已经执行过利用此类数据进行探索性和验证性研究的研究。有经验的组织主要使用观察性 RWD，这些数据不以预测性或回顾性为主，并来源于疾病登记、电子病历和患者问卷等。他们认为 RWD 研究的低成本和大规模是其最重要的优点，并认为其伴随的方法和操作挑战是其最大的限制。然而，他们并没有对 RWD 有一个共同的理解。尽管有分析 RWD 的经验，他们的研究组合仍主要由传统临床试验组成；其中62.5%从未进行任何 RWD 研究的组织仍计划在未来开展该类研究。癌症合作组织已经将 RWD 研究纳入其研究议程，但他们仍缺乏相关知识和专业技能，并且在 RWD 的定义上没有共识。传统临床试验的开展仍是他们的首要任务。 Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Real-world data (RWD) have quickly emerged as an important source of information to address uncertainties about new treatments, including novel anticancer therapies. Many stakeholders are using such data and the evidence derived therefrom to answer the questions that remain about the safety and effectiveness of antitumor medicines after their approval by regulators. Our objective was to investigate the academic RWD study landscape and explore to what extent RWD are being integrated into investigator-initiated clinical research.We designed an online survey that was distributed between May and August 2022 to representatives of cancer cooperative groups active in Europe, North America, South America, Asia, and/or Oceania.In total, 125 cooperative groups operating in 58 different countries and conducting research across 13 distinct cancer domains participated in the survey. While most of the responders (67.2%) did not have a formal policy in place to gather and utilize RWD, a majority (68.0%) had carried out studies involving the analysis of such data before, both for exploratory and confirmatory purposes. The groups that were experienced in capturing and interpreting RWD had mainly worked with observational RWD that were not predominantly prospective or retrospective in nature and which originated from disease registries, electronic health records, and patient questionnaires. They perceived the low costs and the large scale of RWD research to be its most significant benefits, and viewed the accompanying methodological and operational challenges as its biggest constraints. However, they did not have a common understanding of what RWD were. Despite their experience with analyzing RWD, their research portfolio still primarily comprised traditional clinical trials; 62.5% of the groups that had never undertaken any RWD studies were nonetheless planning to initiate them in the future.Cancer cooperative groups are already incorporating RWD studies into their research agendas, but still lack knowledge and expertise in this regard, and do not agree on what RWD are. The conduct of conventional clinical trials continues to be their priority.Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.