Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Office of Program Planning, Analysis, and Evaluation, National Institute of General Medical Sciences, National Institutes of Health, Bethesda, Maryland, USA.
Oncologist. 2020 Mar;25(3):266-270. doi: 10.1634/theoncologist.2019-0503. Epub 2019 Nov 26.
In addition to its primary regulatory role, the Office of Hematology and Oncology Products at the U.S. Food and Drug Administration (FDA) is engaged in many forms of scientific authorship. During the period of 2010 to 2018, FDA oncology staff contributed to 356 publications in the scientific literature. Here, we collaborated with analysts in the Office of Program Planning, Analysis, and Evaluation at the National Institute of General Medical Sciences, National Institutes of Health (NIH), to present a series of analyses aimed at quantifying the characteristics and potential impact of these contributions, as well as characterizing the areas of work addressed. We found that FDA oncology papers are enriched for high-impact publications and have about two times the number of citations as an average NIH-funded paper. Further impact of the publications was measured based on the presence of 65 publications that were cited by guidelines and 12 publications cited by publicly listed clinical trials. The results seen here are promising in determining the impact of FDA oncology publication work but prompt further investigation into longer-term impacts, such as the influence of this work on other regulatory activities at FDA. IMPLICATIONS FOR PRACTICE: This article describes the first comprehensive study of scientific publications produced by U.S. Food and Drug Administration (FDA) oncology staff. The analysis illustrates that staff are highly engaged in publishing in the scientific literature in addition to completing regulatory review work. Publications are generally in clinical medicine, consistent with the large number of medical oncologists working at the Office of Hematology and Oncology Products (OHOP). OHOP publications generally focus either on communicating important regulatory work (approval summaries) or highlighting regulatory science issues to encourage dialogue with the scientific community (commentaries, reviews, and expert working papers). The analysis also suggests that several FDA oncology publications may influence clinical guidelines, but further work is needed to evaluate impact.
除了其主要监管作用外，美国食品和药物管理局（FDA）血液学和肿瘤产品办公室还从事许多形式的科学著作。在 2010 年至 2018 年期间，FDA 肿瘤学工作人员在科学文献中发表了 356 篇论文。在这里，我们与美国国立卫生研究院（NIH）国家普通医学科学研究所计划规划、分析和评估办公室的分析师合作，进行了一系列分析，旨在量化这些贡献的特征和潜在影响，并描述所涉及的工作领域。我们发现，FDA 肿瘤学论文的高影响力出版物更为丰富，引用次数是 NIH 资助论文的两倍。根据 65 篇被指南引用和 12 篇被公开上市临床试验引用的出版物，进一步衡量了出版物的影响。在这里看到的结果令人鼓舞，可以确定 FDA 肿瘤学出版工作的影响，但需要进一步调查更长期的影响，例如这项工作对 FDA 其他监管活动的影响。
本文描述了美国食品和药物管理局（FDA）肿瘤学工作人员发表的科学出版物的首次全面研究。该分析表明，工作人员除了完成监管审查工作外，还高度参与在科学文献中发表论文。这些出版物通常是临床医学方面的，与在血液学和肿瘤学产品办公室（OHOP）工作的大量肿瘤医学家一致。OHOP 出版物通常专注于传达重要的监管工作（批准摘要）或强调监管科学问题，以鼓励与科学界对话（评论、综述和专家工作文件）。分析还表明，FDA 肿瘤学的一些出版物可能会影响临床指南，但需要进一步工作来评估影响。
