An Analysis of Recent FDA Oncology Scientific Publications.

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.

An evaluation of programs to support new investigators at the National Institute of Allergy and Infectious Diseases: Striking a balance with funding for established investigators.

As the largest funder of basic biomedical research in the US, the National Institutes of Health (NIH) has an interest in maintaining a sustainable, productive workforce of investigators. Over the years, NIH has implemented several programs to attract early-stage investigators and other applicants without prior NIH support. The latest of these is the Next Generation Researchers Initiative. These programs have been shown to be successful in meeting NIH-wide goals but their success for any particular NIH institute or center (IC), and in any particular year, is determined by a variety of factors, some extrinsic to an IC's funding decision process. Each IC must balance support for new investigators with funding for productive ongoing programs of research. We examine historical trends in support of new investigators at the National Institute of Allergy and Infectious Diseases (NIAID) over a 22-year period, as well as trends in some major extrinsic influences on that support. The results indicate that NIH's new investigator programs have succeeded in maintaining a balance between the support for new NIAID investigators while also continuing to support an expanded pool of established investigators. The programs have been particularly effective in providing support to early-stage investigators.

Tracing Long-Term Outcomes of Basic Research Using Citation Networks.

In recent years, the science of science policy has been facilitated by the greater availability of and access to digital data associated with the science, technology, and innovation enterprise. Historically, most of the studies from which such data are derived have been econometric or "scientometric" in nature, focusing on the development of quantitative data, models, and metrics of the scientific process as well as outputs and outcomes. Broader definitions of research impact, however, necessitate the use of qualitative case-study methods. For many years, U.S. federal science agencies such as the National Institutes of Health have demonstrated the impact of the research they support through tracing studies that document critical events in the development of successful technologies. A significant disadvantage and barrier of such studies is the labor-intensive nature of a case study approach. Currently, however, the same data infrastructures that have been developed to support scientometrics may also facilitate historical tracing studies. In this paper, we describe one approach we used to discover long-term, downstream outcomes of research supported in the late 1970's and early 1980's by the National Institute of General Medical Sciences, a component of the National Institutes of Health.

Geographically-related outcomes of U.S. funding for small business research and development: Results of the research grant programs of a component of the National Institutes of Health.

This article examines the geographic distribution of funding for the U.S. Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs sponsored by the National Institute of General Medical Sciences (NIGMS). Despite a significant investment in SBIR/STTR and an interest in increasing geographic diversity in the institute's research portfolio, there has not been an assessment of the distribution of NIGMS's SBIR/STTR funding, outcomes associated with that investment, and relationships between the two. The geographic distribution of NIGMS' SBIR/STTR funding was highly concentrated in a small number of states, with a high correlation between each state's funding and its number of small scientific research and development businesses. Affiliation with a major research university was correlated with several measures of innovation and firm success. Our findings are consistent with earlier research showing that economic activity in research and development and research output tend to cluster in geographic regions where knowledge can be generated and shared more efficiently. These findings lend support to an investment strategy for small business research and development that creates networks between major research universities and small businesses.

Using database linkages to measure innovation, commercialization, and survival of small businesses.

Here, we report the results of an outcomes evaluation of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs at the National Institute of General Medical Sciences (NIGMS). Since the programs' inception, assessments of the SBIR/STTR programs at several federal agencies have utilized surveys of former grantees as the primary source of data. Response rates have typically been low, making non-response bias a potential threat to the validity of some of these studies' results. Meanwhile, the availability of large publicly-available datasets continues to grow and methods of text mining and linking databases continue to improve. By linking NIGMS grant funding records, U.S. Patent and Trademark Office data, and business intelligence databases, we explored innovation, commercialization and survival for recipients of NIGMS SBIR/STTR funding. In doing so, we were able to more completely assess several key outcomes of the NIGMS SBIR/STTR program. Our evaluation demonstrated that the NIGMS program performed above baseline expectations along all dimensions, and comparably to other federal agency SBIR/STTR grant programs. In addition, we show that the use of extant data increasingly is a viable, less expensive, and more reliable approach to gathering data for evaluation studies.