Progress Towards a Modernized ClinicalTrials.gov

February 16, 2021

The National Library of Medicine has embarked on several stakeholder activities as part of the roadmap for modernization that we want to highlight in this post. We will also continue to share opportunities for involvement and invite you to join us for an upcoming webinar on February 18, 2021 at 3 pm ET to learn more about our modernization efforts.

Extensions for Early Career Scientists Whose Career Trajectories Have Been Significantly Impacted by COVID-19

February 8, 2021

The COVID-19 pandemic, along with extensive mitigation measures, has adversely affected progress in many biomedical research settings. Evidence from multiple sources, including a survey NIH issued to its supported extramural research workforce last fall, indicates legitimate concerns about career trajectory for early career scientists, including those with caretaker responsibilities. An article by Dr. Erin Gibson and her colleagues argued for a “reset” with focus on early career investigators. One point I took away from this paper is that a reset does not necessarily mean for us to go “back to normal” after the pandemic is over, because that time may have favored certain investigators and disfavored others (something I reflected on in this video and this blog).

Hearing your concerns, NIH issued a Guide Notice last week detailing our approach to support early career scientists whose career trajectories may have been significantly affected by the pandemic as funding will allow). Specifically, NIH is providing an opportunity for recipients in their last year of NIH Fellowship (“F”) and NIH Career Development (“K”) awards who have been impacted by COVID-19 to request extensions. Such extensions will be considered on a case-by-case basis, within the existing constraints of available funding. We encourage you to read the Guide Notice and if appropriate reach out to NIH staff as directed.

Help Us Understand How You Use Common Data Elements in NIH-Supported Research

February 8, 2021

Common Data Elements foster rigor, facilitate data sharing, and allow multiple datasets to be integrated. They also help make data more FAIR (Findable, Accessible, Interoperable, and Reusable). Many different CDEs are currently in use and can vary across research disciplines, so we would encourage researchers check out databases like the NIH CDE Repository for examples, tools, and other related resources. Through a recently released Request for Information (NOT-LM-21-005), we seek your thoughts on how you use CDEs, potential challenges to their adoption, and how NIH might facilitate and incentivize their use to help us plan future CDE-related efforts.

NIH R01 Grant Outcomes of T32 Postdoctoral Participants: Associations with Demographics, Cohort, Degree, and Career Development (K) Awards

February 1, 2021

Postdoctoral NIH T32 programs aim to provide select trainees with experience to enable successful career and research development. Here we present data on NIH career development, or K award, and R01 equivalent research grant outcomes of participants in post-doctoral T32 programs.

Enhancing Diversity at NIH-Funded Conferences

January 22, 2021

At NIH, we have and continue to focus not just on gender equity but on ensuring greater diversity in all aspects of the biomedical workforce. This means, that along with women, members of racial and/or ethnic minority groups, people with disabilities, and those from disadvantaged backgrounds are also included. To help ensure that the nation remains a global leader in scientific discovery and innovation, NIH needs the richness and breadth of varied perspectives that comes from having a pool of highly talented scientists from diverse backgrounds.

In that spirit, today we released a guide notice (NOT-OD-21-053) that updates guidance for NIH R13/U13 Conference Grant applicants and recipients.

Check Out NIH’s New COVID-19 Research Website

January 19, 2021

We are pleased to announce that the new NIH COVID-19 website launched earlier this week. The site provides a central location for trusted, up-to-date, accurate information about NIH research and our strategic role in COVID-19 research. The site complements information made available on our COVID-19: Information for NIH Applicants and Recipients of NIH Funding webpage.

What You Read in 2020

January 19, 2021

Looking back on 2020 includes seeing how well we have done to capture your interest with our Open Mike blog posts.  Did we hit the mark?  Here we analyze page views on the Open Mike blog. Similar to what we did for 2018, below we show the top ten blog posts from 2020 based on overall page views. Posts on topics that are directly related to grant funding were the ones that were viewed the most.

Case Study in Review Integrity: Sharing an Application Being Reviewed

December 18, 2020

Sharing an application with anyone who has not been officially designated to participate in the peer review process is a big no-no. It undermines the integrity of peer review. It disregards the confidentiality that is required of peer reviewers, who specifically sign a confidentiality agreement before accessing the applications. And it is specifically prohibited by NIH peer review policy.

Some Thoughts Following the NIH Inclusion Across the Lifespan 2 Workshop

December 10, 2020

“The [NIH Inclusion Across the Lifespan] policy, and the review and reporting requirements associated with it, should help ensure that children and older adults are not inappropriately excluded from clinical studies. The policy also has the potential to provide a more robust understanding of the full spectrum of participants recruited into clinical studies.”

Together with my NIH colleagues Drs. Marie Bernard and Janine Clayton, we made this point in a 2018 JAMA opinion piece following the inaugural NIH Inclusion Across the Lifespan workshop. Fast forward, we revisited this issue at the NIH’s Inclusion Across the Lifespan 2 workshop held this past September. You can watch the videocast here. The report covering the event was posted today, and I wanted to share some of my takeaways.