Status of Our Initiatives to Strengthen Clinical Trials

Posted on January 6, 2017 by Mike Lauer

In September Dr. Carrie Wolinetz and I blogged about our policy reforms to build a more robust clinical trials enterprise through greater stewardship and transparency at each phase of the clinical trial journey from conception to sharing of results. We discussed how these efforts promise to improve the quality and efficiency of clinical trials, translating into more innovative and robust clinical trial design, and accelerated discoveries that will advance human health.

Over the past months we have continued to partner with the community to work through the implementation of these new policies, developing responses to frequently asked questions and even reconsidering the timing of our single IRB policy to give our grantees time to work through how to operationalize the change. …. Continue reading →

One Year (or so) of “Open Mike”

Posted on December 30, 2016 by Mike Lauer

As the year 2016 ends, my first full year in my new role here at NIH, I’d like to reflect on some of the topics covered here on Open Mike. Thanks to our NIH Regional Seminars, I have had the pleasure of hearing feedback from some of you in person, and I am also greatly appreciative of our virtual interactions, through the thoughtful comments posted by blog readers in this space. Our blog opened on October 19, 2015, when I noted that NIH is an extraordinary success story; even skeptics identify NIH as a government program that works. But at the same time, I also noted that all is not well with the biomedical research enterprise. In many respects, the 50+ blogs that followed have dug deeper into our anxieties and challenges. The sidebar highlights five major themes arising over the past year or so, and blogs related to those categories. To get a sense of community interest, we have also compiled some reader statistics. Further below, Table 1 shows which blogs, as of December 27, received the most page views, and Table 2 shows which blogs received the most comments. These themes, your viewership, and your comments …. Continue reading →

Characteristics and Outcomes of R01 Competing Renewal Applications (“Type 2s”)

Posted on December 22, 2016 by Mike Lauer

An investigator’s long-term success depends not only on securing funding, but on maintaining a stable funding stream. One way to assure continued funding is to submit a competing renewal application. However, as we noted earlier this year, while new investigators were almost as successful as experienced investigators in obtaining new (type 1) R01s, the difference between new investigator and experienced investigator success rates widens when looking at competing renewals (type 2s), and success rates of new investigators’ first renewals were lower than those of experienced investigators. In addition, we know that since the end of NIH’s budget doubling in 2003, success rates for competing renewals of research project grants overall have decreased. To further understand trends in success rate for R01 competing renewals (“type 2s”) I’d like to share some additional analyses where we look at characteristics of type 2 R01 applications, and the association of their criterion scores with overall impact score and funding outcomes. Continue reading →

NRSA Postdoctoral Stipend Levels for Fiscal Year 2017

Posted on December 16, 2016 by Mike Lauer

Yesterday, NIH published a guide notice establishing stipend levels for postdoctoral trainees and fellows supported by Kirschstein-NRSA awards in fiscal year (FY) 2017. The 2017 increase of NRSA postdoctoral stipend levels reflects …. Continue reading →

The 21st Century Cures Act, and Perspectives from NIH

Posted on December 14, 2016 by Mike Lauer

You may have been following news of the 21st Century Cures Act, a landmark piece of legislation with provisions for healthcare, medicine, and research. Republican and Democratic lawmakers supported this bill through its development and eventual passage, and yesterday, President Obama signed the bill into law. The Act establishes a multitude of important changes to our nation’s approach to supporting and funding health care, medical interventions, and research. Readers of this blog may be particularly interested in the many changes directly relevant to NIH’s mission. A New England Journal of Medicine Perspective essay …. Continue reading →

How Many Researchers Were Supported by NIH as Trainees?

Posted on November 28, 2016 by Mike Lauer

Earlier this year we reported on the unique numbers of research project grant (RPG) awardees and applicants each year since the end of the NIH doubling, in 2003. We described how the number of unique RPG awardees has remained relatively constant, while the number of applicants (as assessed over 5-year windows) has steadily and markedly increased.
A number of readers asked us about the prior NIH-supported research training and career development of these investigators. Among RPG awardees, what proportion had received prior fellowship, training, or career development (F, T, or K) awards? And perhaps of greater interest, among unsuccessful, unfunded applicants, what proportion had received prior fellowship, training or career awards?
To answer these questions, we start with a quick recap. …. Continue reading →

Additional Guidance Available on NRSA Stipends for Postdocs

Posted on November 23, 2016 by Mike Lauer

We’d like to call your attention to a recently released NIH Guide notice that provides awardees with additional guidance related to the increases in postdoctoral NRSA stipends for postdoctoral researchers with 0,1 and 2 years of experience that go into effect December 1, 2016. As you may recall from earlier blog posts, under the Department of Labor’s revisions to the Fair Labor Standards Act (FLSA), as of December 1, 2016, US salaried, full-time professional workers will be entitled to overtime pay if they are paid below the new FLSA defined threshold. As described in an op-ed by NIH Director Francis Collins and Department of Labor Director Thomas Perez, “Fair Pay for Postdocs: Why We Support New Federal Overtime Rules,” NIH will increase postdoctoral NRSA stipends to start at levels above the new FLSA threshold, recognizing the contributions that postdoctoral researchers make to the NIH mission and that postdoctoral research activities – like most biomedical research careers – often exceed forty hours a week and do not neatly fall into hourly shifts. ….. Continue reading →

R01 and R21 Applications & Awards: Trends and Relationships Across NIH

Posted on November 4, 2016 by Mike Lauer

As described on our grants page, the R21 activity code “is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development.” NIH seeks applications for “exploratory, novel studies that break new ground,” for “high-risk, high-reward studies,” and for projects that are distinct from those that would be funded by the traditional R01. R21 grants are short duration (project period for up to 2 years) and lower in budget than most R01s (combined budget over two years cannot exceed $275,000 in direct costs). NIH institutes and centers (ICs) approach the R21 mechanism in variable ways: 18 ICs accept investigator-initiated R21 applications in response to the parent R21 funding opportunity, while 7 ICs only accept R21 applications in response to specific funding opportunity announcements. As mentioned in a 2015 Rock Talk blog, we at NIH are interested in trends in R01s in comparison to other research project grants, so today I’d like to continue and expand on looking at R01 and R21 trends across NIH’s extramural research program. …. Continue reading →

Are You On the Fence About Whether to Resubmit?

Posted on October 28, 2016 by Mike Lauer

When applicants receive their summary statement resulting from the review of an application that was assigned a score outside of the ICs funding range, there are important decisions to be made that, ideally, should be based upon evidence. What is the likelihood that an application like this one will be funded? If I resubmit the application, what changes might improve the chances for a successful resubmission?

Recall that in 2014, NIH relaxed its resubmission policy (OD-14-074) to allow applicants to submit a new (A0) application following an unsuccessful resubmission application. Also, we recently posted a piece showing that review outcomes for new applications submitted following an unsuccessful resubmission had about the same funding success as other new applications. But some applicants may wonder, what is the funding success for a resubmission application? …. Continue reading →

Applying the Relative Citation Ratio as a Measure of Grant Productivity

Posted on October 21, 2016 by Mike Lauer

Last April we posted a blog on the measurement of citation metrics as a function of grant funding. We focused on a group of R01 grants and described the association of a “citation percentile” measure with funding. We noted evidence of “diminishing returns” – that is increased levels of funding were associated with decreasing increments of productivity – an observation that has been noted by others as well.

We were gratified by the many comments we received, through the blog and elsewhere. Furthermore, as I noted in a blog last month, our Office of Portfolio Analysis has released data on the “Relative Citation Ratio,” (or RCR) a robust field-normalized measure of citation influence of a single grant (and as I mentioned, a measure that is available to you for free).

In the follow-up analysis I’d like to share with you today, we focus on a cohort of 60,447 P01 and R01-equivalent grants (R01, R29, and R37) which were first funded between 1995 and 2009. Through the end of 2014, these grants yielded at least 654,607 papers. We calculated a “weighted RCR” value for each grant, …. Continue reading →

NIH Extramural Nexus