Alex Mainor
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View article: Best practices for clinical trials data harmonization and sharing on NHLBI bioData catalyst (BDC) learned from CONNECTS network COVID-19 studies
Best practices for clinical trials data harmonization and sharing on NHLBI bioData catalyst (BDC) learned from CONNECTS network COVID-19 studies Open
The need for collaborative and transparent sharing of COVID-19 clinical trial and large-scale observational study data to accelerate scientific discovery and inform clinical practice is critical. Responsible data-sharing requires addressin…
View article: Taking AIM at serious illness: implementing an access to investigational medicines expanded access program
Taking AIM at serious illness: implementing an access to investigational medicines expanded access program Open
When seriously ill patients have exhausted all treatment options available as part of usual care, the use of investigational agents may be warranted. Food and Drug Administration’s (FDA) Expanded Access (EA) pathway provides a mechanism fo…
View article: Development and implementation of the National Heart, Lung, and Blood Institute COVID-19 common data elements
Development and implementation of the National Heart, Lung, and Blood Institute COVID-19 common data elements Open
Background: Coronavirus Disease 2019 (COVID-19) instigated a flurry of clinical research activity. The unprecedented pace with which trials were launched left an early void in data standardization, limiting the potential for subsequent dat…