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NIH Extramural News - December 2016/January 2017

December 2016 / January 2017

Open Mike

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

Top Stories

Take A Look At Our New Application Instructions

Reading and following application instructions is key to a smooth application submission process. This is why we’re continually seeking to make it easier for you to find and understand the information you need. If you take a look at the December release of our application guide, you will see that we’ve worked really hard to simplify the language and presentation of our application instructions. A recent Guide notice highlights our changes: ….Continue reading

You Ask, We Answer

 

·        Do I Have to Take a Particular Good Clinical Practice (GCP) Training Program to Meet NIH Policy Expectations?

·        How Often Must Clinical Trial Investigators and Clinical Trial Staff Update Their Good Clinical Practice (GCP) Training?

·        Does NIH Expect Completion of GCP Training by the January 1, 2017 Effective Date?

 

Calendar

January 16 (Monday), 2017: NIH Closed For the Federal Holiday

NIH (including help desks) will be closed Monday, January 16, 2017, for the federal holiday (Birthday of Martin Luther King, Jr.). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day.