This page provides access to FDA-Catalyst projects funded by the U.S. Food and Drug Administration.
FDA-Catalyst supplements the Sentinel System. The data FDA-Catalyst provides comes from interactions with patients and/or providers. FDA-Catalyst combines this data with data included in the Sentinel infrastructure.
FDA-Catalyst is an important addition to surveillance and research of marketed medical products. It leverages the Sentinel Infrastructure and other capabilities of the Sentinel System to answer a wider range of questions than can be addressed by the Sentinel System data alone. These activities ultimately complement the existing postmarket surveillance system.
Current and completed activities are included in the table below.
|COVID MyStudies Mobile App for E-Consent||In progress||06/01/2020|
|FDA-Catalyst Alignment with the CMS Linkage to the PCORI RELIANCE Trial||In progress||05/08/2019|
|Implementation of a Randomized Controlled Trial to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation (IMPACT-AFib)||Complete||05/07/2019|
|FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries||In progress||10/15/2018|
|Collection of Patient-Provided Information Through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research||Complete||01/02/2017|