NIH and FDA Seek Feedback on Clinical Trial Protocol Template

March 31, 2016

I’d like to call your attention to an opportunity to provide comments on a proposed clinical trial protocol template, developed by the FDA and NIH, and informed by the guidance set forth by the International Conference on Harmonisation (ICH) E6 Good Clinical Practice. The template provides a standard format, and corresponding instructions and sample text, for…

NIH’s Commitment to Basic Science

March 25, 2016

Several years ago, my colleagues and I analyzed the diversity of disease research supported by NIH’s National Heart, Lung, and Blood Institute, and wrote about the importance of maintaining a diverse scientific portfolio. In times of scarce resources, it is tempting to prioritize investments that seem to offer a better promise of direct returns. In my current position as NIH’s deputy director for extramural research, I still feel strongly that maintaining a strong commitment to long-term goals and maintaining a diverse science portfolio ultimately balances risk and long- versus short-time pay-offs. Basic science is an essential component of this diverse portfolio. ….

A Pilot Partnership to Find Private Support for Unfunded Applications

March 23, 2016

When I was an editor at JAMA, we often considered papers that were strong, received favorable reviews, and yet could not be published for lack of space. As it turned out, we had an option other than outright rejection: we could offer authors a user-friendly pathway by which their papers, and the reviews that went with them, could be forwarded for consideration at another journal (e.g. JAMA Internal Medicine). Later, when I came to NIH I wondered whether it was even theoretically possible for a funding agency to do something similar: arrange a way for highly meritorious but unfunded projects to find their way to willing, even eager, alternate private-sector sponsors. Effectively, we could develop public-private partnerships to extend the system’s ability to fund high-quality science and scientists. ….

FY2015 by the Numbers, and a Quick Look at Recent Trends

March 14, 2016

When I was an extramural program division director, NIH applicants and awardees would often ask me questions like “Do you fund research on certain topics?” or “What’s been happening to success rates for certain kinds of grants?” or “How much money do certain kinds of grants usually get?” Often I would respond by going to the RePORT website and running a query or two (or three or more); I would not only show the results but also show the applicant/awardee how s/he could run even more queries on their own. Indeed the website offers an extraordinary data resource for the public, ranging from the RePORTER query tool to find certain kinds of grants, to a bounty of prepared reports, to tools for exporting large data tables about projects, resulting publications, and (more recently) patents. With the Matchmaker tool, one can even copy and paste some text (e.g. a draft abstract of your next proposal) and find similar funded grants. The NIH Data Book on our RePORT website now incorporates NIH’s fiscal year 2015 data. Let’s reflect on funding trends over the past three years, and other recently updated application and award summary data. ….

Publication Impact of NIH-funded Research – A First Look

March 2, 2016

In a recent PNAS commentary, Daniel Shapiro and Kent Vrana of Pennsylvania State University, argue that “Celebrating R and D expenditures badly misses the point.” Instead of focusing on how much money is spent, the research enterprise should instead focus on its outcomes – its discoveries that advance knowledge and lead to improvements in health.

Of course, as we’ve noted before, measuring research impact is hard, and there is no gold standard. But for now, let’s take a look at one measure of productivity, namely the publication of highly-cited papers. Some in the research community suggest that a research paper citation is a nod to the impact and significance of the findings reported in that paper – in other words, more highly-cited papers are indicative of highly regarded and impactful research.

If considering highly-cited papers as a proxy for productivity, it’s not enough that we simply count citations, because publication and citation behaviors differ greatly among fields – some fields generate many more citations per paper. ….

New to the World of NIH Grants? Attend a 2016 NIH Regional Seminar

February 29, 2016

One of my favorite “job tasks” is to spend time meeting with scientists and science administrators who are new to the NIH environment or are attempting to launch their careers in science. Invariably I’m asked, “What wisdom do you have to offer?” Of course, I’ll mention that it’s key to find a top-notch mentor (or mentors), that it’s critical to follow one’s passion, and that it’s always a good idea to work on grant proposals well in advance of deadlines, allowing ample time to seek input from colleagues and critics. But … that’s not enough. In today’s dynamic world, one in which we can not only no longer take science funding for granted (let alone increases in science funding), it’s not enough to be an outstanding scientists or an outstanding administrator. One also has to be an outstanding citizen. ….

Are Attempts at Renewal Successful?

February 16, 2016

On my first day on the job as NIH Deputy Director for Extramural Research, one of my colleagues asked me a question: Is it true that it is more difficult to renew a grant than it is to get one in the first place? Some people wonder whether NIH’s interest in supporting new investigators who are trying to get their first grant negatively impacts the other investigators’ attempts to renew their grants.
To address this question we gathered data on R01-equivalent success rates for new and experienced investigators seeking funding in fiscal years (FY) 2013 through 2015. ….

Authentication of Key Biological and/or Chemical Resources in NIH Grant Applications

January 29, 2016

The fourth and final segment in our series on rigor and transparency in research grant and career development award applications focuses on authentication of key biological and/or chemical resources. Research performed with unreliable or misidentified resources can negate years of hard work and eliminate any chance for a study to be reproduced or expanded upon. For this reason, it is imperative that researchers regularly authenticate key resources used in their research. ….