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.
“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.
It’s been over eight months since the COVID-19 pandemic crisis struck, changing every facet of life as we knew it. The U.S. biomedical research enterprise was not spared, as lockdowns and severe restrictions on activities took hold across the country. At the time, we offered our perspectives on efforts we could take to cushion the shock. Since that time, much has happened. COVID-19 research has blossomed with impressive results including FDA approval of a therapeutic agent (remdesivir, which was found to have value in a large-scale NIH-funded trial), development of several candidate vaccines that have already made to pivotal Phase 3 trials, and the rapid development of a variety of diagnostic testing platforms. However, research unrelated to COVID has seen a different picture. Continue reading
From shifting public health needs to the unprecedented pace of biomedical discovery, everything about the coronavirus response is evolving. This goes for the NIH-Wide Strategic Plan for COVID-19 Research as well, so too must it evolve.
We want your help on the next iteration of the Plan. A Request For Information released yesterday seeks public feedback on the current Plan (NOT-OD-21-018). You or your organization can submit ideas here by December 7, 2020.