CTSA Ansible – March 2021

The Recruitment Innovation Center (RIC) has been heavily involved in multisite COVID-19 trial design and implementation, having consulted on 29 COVID-19 related studies as of this writing. While striving to maintain its values of community engagement, participant-informed methods, and scalable design, the RIC has developed new tools and strategies that work in this transformed clinical trial space.

The purpose of this toolkit is to share the community input the RIC has received, and the resources it has developed, that can help study teams conduct trials in a manner that is safe, trustworthy, and respectful of all participants. Organized by the continuum of recruitment activities needed to complete a trial, the RIC presents here the ideas, concepts, and materials that it has successfully implemented to support recruitment and retention for COVID-19 trials, as well as for non-COVID trials taking place during the pandemic.

The National COVID Cohort Collaborative (N3C) continues to grow as a robust EHR data resource, now with over 3 million persons represented and 4 billion rows of data from more than 42 sites. Currently, 24 multidisciplinary Domain Teams composed of clinical and subject matter experts, statisticians, informaticists, and machine learning specialists are addressing the most pressing clinical questions. N3C data can be utilized to: understand COVID-19’s impact on health, collect pilot data for grant submissions, train algorithms on larger datasets, inform clinical trial design, learn how to use tools for large-scale COVID-19 data, and validate results.

Telehealth is an emerging field.  Prior to the pandemic, telehealth was shown in several chronic conditions to improve access, reduce hospitalization rates, and have lower costs to the patient than traditional in-person visits. These interventions are adaptable and have the potential to impact healthcare in communities that are medically underserved and under-resourced. This virtual Un-Meeting is a ½ day attendee-driven event with time devoted to idea sharing, developing relationships, and identifying collaborative opportunities.

The NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities focuses on addressing misinformation around COVID-19, engaging trusted partners and messengers in the delivery of accurate information, and educating communities on the importance of inclusion in clinical research to overcome COVID-19. The CEAL website includes up-to-date information, infographics, videos, toolkits, social media and key digital links that can be shared with your communities to help keep them informed.

NIH recognizes that the high cost of childcare impacts graduate students and post-doctorates funded through NRSA fellowships, and their ability to successfully complete their training and fully participate in the extramural research workforce. Therefore, as part of our ongoing efforts to support family-friendly work environments for the NIH-supported workforce, NIH will begin providing childcare support to recipients of NRSA fellowships, on or after April 8, 2021. In Phase 2 of this initiative, a similar cost will be provided for NRSA-supported trainees (anticipated early FY 2022). For Phase 2 of this initiative, additional information and implementation guidance will be issued. Frequently Asked Questions are available here:https://grants.nih.gov/faqs#/funding_programs_childcare_costs.htm.

It is highly likely that winter storms across the U.S. will adversely impact the ability of NIH applicants and recipients in the impacted areas to submit applications and/or reports in a timely manner. Generally, NIH considers accepting late applications when delays occur because the applicant or recipient organization is officially closed due to a natural disaster or other emergency. Given the current combination of the existing Presidentially-declared Public Health Emergency concerning COVID-19 and the winter storms, NIH Institutes and Centers may, at their discretion, accept late applications to Funding Opportunity Announcements reviewed at their IC on a case-by-case basis due to other circumstances than an official closure.