Dataset Information

An Analysis of Recent FDA Oncology Scientific Publications.

ABSTRACT: 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.

SUBMITTER: Schneider JA

PROVIDER: S-EPMC7066718 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

An Analysis of Recent FDA Oncology Scientific Publications.

Schneider Julie A JA Miklos Andrew C AC Onken James J Gong Yutao Y Calcagno Anna Maria AM Blumenthal Gideon M GM Aragon Richard R Pazdur Richard R

The oncologist 20191126 3

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 pres ...[more]

PMID: 32162806

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Project description:BackgroundBurnout and compassion fatigue are closely related concepts. Burnout is thought to develop from occupational stress while compassion fatigue results from being in a caregiver role leading to inability to get engaged in a caring relation. The objective of the current study was to investigate research trends, themes, citations, and key players of publications on burnout and compassion fatigue among healthcare providers.MethodsA validated search query was developed and implemented in the Scopus database. The study period was all times up to 2019.ResultsResearch query found 4416 publications. Publications started in 1978. Steep growth in the number of publications was observed in the last decade. There were seven research themes in the retrieved publications; six for burnout and one for compassion fatigue. Approximately 36% of the retrieved publications were about nurses; 36% were about physicians, 10% were about medical residents and the remaining did not include a specific profession. The retrieved publications received an average of 22.2 citations per article. Four of the top 10 active journals were in the field of nursing and two in the field of general medicine, one in public health, one in neurology, one in psychology, and one was multidisciplinary. The USA ranked first with 1292 (29.3%) articles followed by Spain (n = 248; 5.6%) and the UK (n = 247; 5.6%). Mayo Clinic was the most active institution (n = 93; 2.1%) followed by Harvard University (n = 46; 1.0%) and University of Washington, Seattle (n = 45; 1.0%). A total of 16,108 authors participated in publishing the retrieved documents, an average of 3.6 authors per article. Shanafelt, T.D. was the most active author (n = 78; 1.8%) followed by Dyrbye, L.N. (n = 43; 1.0%), and West, C.P. (n = 37; 0.8%). A total of 472 (10.7%) articles declared funding.ConclusionThe current study was carried out to draw attention to the wellbeing of healthcare providers. Retrieved literature was dominated by high-income countries. Lack of information from low- and middle-income countries will hinder planning for interventional strategies and will negatively affect the health system and the patients. Health researchers in low- and middle-income countries need to focus on burn out and compassion fatigue.

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An Analysis of Recent FDA Oncology Scientific Publications.

Publications

An Analysis of Recent FDA Oncology Scientific Publications.

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