The 21st Century Cures Act, and Perspectives from NIH

December 14, 2016
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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 ….

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How Many Researchers Were Supported by NIH as Trainees?

November 28, 2016
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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. ….

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Additional Guidance Available on NRSA Stipends for Postdocs

November 23, 2016
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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. …..

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

November 4, 2016
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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. ….

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Are You On the Fence About Whether to Resubmit?

October 28, 2016
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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? ….

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Applying the Relative Citation Ratio as a Measure of Grant Productivity

October 21, 2016
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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, ….

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Give Us Your Feedback on Standards for Preprints, and Other Interim Research Products

October 11, 2016
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Many scientific disciplines, like physics and mathematics, routinely communicate research findings through preprints — manuscripts that have not yet gone through the formal peer review, editing, or journal publishing process. However, this is still a relatively novel concept in biology and clinical research. …. we at NIH are interested in feedback from you, to get a fuller understanding of the current use of preprints in the broader NIH-supported research community, accepted preprint standards, whether preprints should be included in NIH applications and reports, and how investigators could report them. …. Not only are we interested in your current use of preprints — and other interim research products — but perhaps most importantly we’d like your feedback on the specific standards that need to be in place for their citation, particularly for citation in NIH applications and reports ….

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Improving Visibility of NIH-supported Clinical Trial Activities and Results

September 16, 2016
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In a separate post today, we provide an overview of the various reforms the NIH is leading to enhance our stewardship of clinical trials. In this post we’d like to focus a bit more on our efforts to broadly disseminate clinical trial availability and results information.

Timely dissemination of clinical trial results information has been a problem, one that has been documented more than once, and that appears to apply to NIH- as well as non-NIH funded trials. To realize the benefits of a clinical trial, the findings must be available to the public as soon as possible after the trial has concluded. This is not only responsible use of taxpayer dollars for publicly funded trials, but also fulfills our responsibility to the individuals who volunteered in these studies with an understanding that their participation would contribute to advancing medical knowledge. Today, NIH announced a new policy that will complement a new federal regulation, referred to here as the Final Rule, also released today, to improve the accessibility of information on clinical trial availability and on the outcomes and results of completed trials.

As you likely know, to carry out the laws passed by Congress, federal agencies issue regulations that govern the activities of the agency and the applicable community. The “Final Rule” announced today by the U.S. Department of Health and Human Services is …

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Building Better Clinical Trials through Stewardship and Transparency

September 16, 2016
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NIH is the largest public funder of clinical trials in the United States. As stewards of this research enterprise, we have been actively listening and discussing how to overcome hurdles and shortcomings that we, and others in the research community, have identified. If you’ve been following the conversation, you’ll know that NIH already has implemented some key reforms to enhance clinical trial stewardship. Today, in a Viewpoint Essay published in the Journal of the American Medical Association (JAMA), we provide an overview of how these reforms, and new initiatives, fit in to the broader picture of building a better clinical trial enterprise through better stewardship, accountability, and transparency.

Figure 1 illustrates the clinical trial “lifespan”, and key opportunities for improving the quality and efficiency of clinical trials – opportunities that translate into more innovative and robust clinical trial design, and accelerated discoveries that will advance human health. NIH is leading a multi-faceted effort that addresses shortcomings and challenges throughout this lifespan, including the application and award process; the scientific review of trial applications; post-award management and oversight; sharing of trial data; and dissemination of research results information to the public. ….

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Measuring Impact of NIH-supported Publications with a New Metric: the Relative Citation Ratio

September 8, 2016
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In previous blogs, we talked about citation measures as one metric for scientific productivity. Raw citation counts are inherently problematic – different fields cite at different rates, and citation counts rise and fall in the months to years after a publication appears. Therefore, a number of bibliometric scholars have focused on developing methods that measure citation impact while also accounting for field of study and time of publication. We are pleased to report that on September 6, PLoS Biology published a paper from our NIH colleagues in the Office of Portfolio Analysis on “The Relative Citation Ratio: A New Metric that Uses Citation Rates to Measure Influence at the Article Level.” Before we delve into the details and look at some real data, ….

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