The Issue that Keeps Us Awake at Night
The most important resource for the successful future of biomedical research is not buildings, instruments, or new technologies – it’s the scientists doing the work. But by now, it’s no longer news that biomedical researchers are stressed – stressed by a hypercompetitive environment that’s particularly destructive for early- and mid-career investigators. But those are the researchers who, if we don’t lose them, will comprise the next generation of leaders and visionaries. Almost 10 years ago, the National Institutes of Health (NIH) took steps to improve funding opportunities for “early stage investigators...
Source: NIH Extramural Nexus - May 4, 2018 Category: Research Authors: Michael Lauer and Francis Collins Tags: blog Open Mike Biomedical Workforce NGRI Source Type: funding

Open Mike Perspective: Healthy Skepticism when Focusing Solely on Surrogate Endpoints in Clinical Research
I recently wrote an essay for the NIH’s Science, Health, and Public Trust series to encourage a healthy bit of skepticism about clinical studies that solely involve surrogate end-points (e.g. changes in “biomarkers” like blood cholesterol levels or findings on an electrocardiogram). To make my point, I described experiences with a well-known cardiovascular trial — one that focused on the risk of sudden death among heart attack survivors. I encourage readers in this essay to not just assume that treating a surrogate endpoint will automatically treat the underlying condition. Sometimes it does.  But sometimes it...
Source: NIH Extramural Nexus - May 3, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Clinical Trials innovation Perspectives Source Type: funding

Impact of Teams Receiving NIH Funding
Almost 11 years ago, Stefan Duchy, Benjamin Jones, and Brian Uzzi (all of Northwestern University) published an article in Science on “The Increasing Dominance of Team in Production of Knowledge.”  They analyzed nearly 20 million papers published over 5 decades and 2.1 million patents and found that across all fields the number of authors per paper (or patent) steadily increased, that teams were coming to dominate individual efforts, and that teams produced more highly cited research. In a Science review paper published a few weeks ago, Santo Fortunato and colleagues offered an overview of the “Science of Science....
Source: NIH Extramural Nexus - April 4, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Collaboration Impact of NIH Funding publications relative citation ratio Team Science Source Type: funding

There ’s No I In Team: Assessing Impact of Teams Receiving NIH Funding
Almost 11 years ago, Stefan Duchy, Benjamin Jones, and Brian Uzzi (all of Northwestern University) published an article in Science on “The Increasing Dominance of Team in Production of Knowledge.”  They analyzed nearly 20 million papers published over 5 decades and 2.1 million patents and found that across all fields the number of authors per paper (or patent) steadily increased, that teams were coming to dominate individual efforts, and that teams produced more highly cited research. In a Science review paper published a few weeks ago, Santo Fortunato and colleagues offered an overview of the “Science of Science....
Source: NIH Extramural Nexus - April 4, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Collaboration Impact of NIH Funding publications relative citation ratio Team Science Source Type: funding

Do Reviewers Read References? And If So, Does It Impact Their Scores?
In March 2017, we wrote about federal funders’ policies on interim research products, including preprints. We encouraged applicants and awardees include citations to preprints in their grant applications and progress reports. Some of your feedback pointed to the potential impact of this new policy on the peer review process. Some issues will take a while to explore as preprints become more prevalent. But some we can dig into immediately. For example, how do references cited in an application impact review?  To start to address this question, we considered another one as well: do peer reviewers look at references – eit...
Source: NIH Extramural Nexus - March 30, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike applications citations Peer review Source Type: funding

Celebrating Women ’s History Month: Scientist Spotlight
Women’s History Month quiz question (and no “Googling” allowed): Who was Joan Procter? I didn’t know either until a few months ago when I learned that my colleague, Dr. Patricia Valdez, wrote a children’s book, called “Joan Procter, Dragon Doctor.”  Alfred A Knopf published Patricia’s and her illustrator Felicita Sala’s book a few weeks ago, on March 13, 2018.  Critics have already acclaimed the work: Publisher’s Weekly in a starred review wrote, “Valdez paints a portrait of a unique woman whose love for reptiles developed into a gratifying career.” So, who was Joan Procter?  She was born in ...
Source: NIH Extramural Nexus - March 27, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Source Type: funding

Make Your Voice Heard! We want Your Ideas to Reduce Administrative Burden in Research with Laboratory Animals
NIH has, for many years, been concerned about the increasing burden of applying for, reporting on, and the costs faced by researchers when complying with requirements on  federally-funded research grants— so much so that it is even called out in our strategic plan as an area to address. Today, as we continue to implement the 21st Century Cures Act, NIH is requesting public feedback on some proposed approaches to reduce administrative burden on investigators use of laboratory animals in biomedical research (NOT-OD-18-152 and Federal Register Notice 2018-05173). Together with our colleagues at the U.S. Department of Agric...
Source: NIH Extramural Nexus - March 15, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Administrative Burden Animal Welfare Request For Information (RFI) Source Type: funding

How Many Researchers, Revisited: A Look at Cumulative Investigator Funding Rates
In May 2016, we posted a blog on “How Many Researchers” NIH supports.  We cited the findings of a University of Wisconsin workshop, which concluded that the biomedical research enterprise suffers from two core problems: too many scientists vying for too few dollars and too many post-docs seeking too few faculty positions.  We also noted that NIH leadership and others were increasingly interested in describing the agency’s portfolio not only in terms of the numbers of awards and dollars (as we do each year in our “By the Numbers” reports), but also in terms of the numbers of researchers those awards support.  T...
Source: NIH Extramural Nexus - March 7, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Funding data R01 Success Rate Source Type: funding

FY 2017 By the Numbers
We recently released our annual web reports, success rates and NIH Data Book with updated numbers for fiscal year 2017. Looking at data across both competing and non-competing awards, NIH supports approximately 2,500 organizations.  In 2017 about 640 of these organizations received funding for competing Research Project Grants (RPGs) which involved over 11,000 principal investigators. The average size of RPGs increased by over 4%, from $499,221 in FY 2016 to $520,429 in FY 2017. Similarly, in FY 2017 the average size of R01-equivalent awards increased from $458,287 to $482,395 (by over 5%). As we continue to monito...
Source: NIH Extramural Nexus - March 7, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Award rate Funding data R01 Success Rate Source Type: funding

Requesting Your Input on the Draft NIH Strategic Plan for Data Science
To capitalize on the opportunities presented by advances in data science, the National Institutes of Health (NIH) is developing a Strategic Plan for Data Science. This plan describes NIH’s overarching goals, strategic objectives, and implementation tactics for promoting the modernization of the NIH-funded biomedical data science ecosystem. As part of the planning process, NIH has published a draft of the strategic plan today, along with a Request for Information (RFI) to seek input from stakeholders, including members of the scientific community, academic institutions, the private sector, health professionals, profession...
Source: NIH Extramural Nexus - March 5, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike big data Request For Information (RFI) Source Type: funding

Having Challenges Tracking Down Students and Postdocs at the Time of the RPPR? Here is a Tip to Make It Easier …
Having challenges tracking down students and postdocs at the time of reporting? Establishing a process where you have students and postdocs establish an eRA Commons account at the time they start working on an NIH grant award can save you a lot of time and energy trying to track down people who may no longer be at your institution at the time of your Research Performance Progress Report (RPPR) submission. You may even want to have them create an ORCID ID as well! (In case you missed it, read the November 2017 Open Mike blog post to learn more about eRA Commons and ORCID integration.) (Source: NIH Extramural Nexus)
Source: NIH Extramural Nexus - January 30, 2018 Category: Research Authors: NIH Staff Tags: New Resources Source Type: funding

NIH Announces Inclusion Across the Lifespan Policy
Last month, NIH announced a revision (NOT-OD-18-116) to a decades-old policy originally conceived in response to concerns that children were not appropriately included in clinical research. These changes broaden the policy to address inclusion of research participants of all ages, and as discussed at the last Advisory Committee to the NIH Director meeting, will apply beginning in 2019 to all NIH-supported research involving human subjects. Our goal is to ensure that the knowledge gained from NIH-funded research is applicable to all those affected by the conditions under study. To get here, NIH solicited feedback from exp...
Source: NIH Extramural Nexus - January 24, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Clinical Trials Source Type: funding

Continuing to Strengthen Inclusion Reporting on NIH-funded Phase III Trials
This reporting requirement applies to new and competing awards made on or after December 13, 2017.  Findings from valid analyses based on sex/gender and race/ethnicity from these applicable NIH-defined Phase III clinical trials must now be reported in ClinicalTrials.gov within one year of completion of data collection for the study’s primary outcome measures. This builds on existing requirements for registering and reporting results in ClinicalTrials.gov. If you have an applicable NIH-defined Phase III clinical trial that was already underway before the effective date, the requirement will not affect you for your curren...
Source: NIH Extramural Nexus - January 8, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Clinical Trials Clinicaltrials.gov Source Type: funding

Further Refining Case Studies and FAQs about the NIH Definition of a Clinical Trial in Response to Your Questions
In August and September we released case studies and FAQs to help those of you doing human subjects research to determine whether your research study meets the NIH definition of a clinical trial. Correctly making this determination is important to ensure you are following the initiatives we have been implementing to improve the transparency of clinical trials, including the need to pick clinical trial -specific funding opportunity announcements for due dates of January 25, 2018 and beyond. We have made no changes to the NIH definition of a clinical trial, or how the definition is interpreted.  What we have done is revise ...
Source: NIH Extramural Nexus - January 4, 2018 Category: Research Authors: Mike Lauer Tags: blog Open Mike Clinical Trials Source Type: funding

Two Years (or so) of “Open Mike”
Last year, as I reflected on finishing my first full year as NIH Deputy Director for Extramural Research, I noted five themes that reflected most of the content of this blog: applicant behavior, activity, and outcomes; peer review; basic science; biomedical research workforce and training; and scientific rigor, transparency, and research impact. Looking back on 2017, which was certainly a busy and active year, many of these themes continue to be at the forefront, though one in particular, the make-up and future of the biomedical research workforce, has been the center of much debate. On May 2, we posted a blog on “Implem...
Source: NIH Extramural Nexus - December 29, 2017 Category: Research Authors: Mike Lauer Tags: blog Open Mike General Source Type: funding