A Versatile and Scalable Platform That Streamlines Data Collection for Patient-Centered Studies: Usability and Feasibility Study.

ABSTRACT:

Background

The Food and Drug Administration Center for Biologics Evaluation and Research (CBER) established the Biologics Effectiveness and Safety (BEST) Initiative with several objectives, including the expansion and enhancement of CBER's access to fit-for-purpose data sources, analytics, tools, and infrastructures to improve the understanding of patient experiences with conditions related to CBER-regulated products. Owing to existing challenges in data collection, especially for rare disease research, CBER recognized the need for a comprehensive platform where study coordinators can engage with study participants and design and deploy studies while patients or caregivers could enroll, consent, and securely participate as well.

Objective

This study aimed to increase awarene

SUBMITTER: Huang H 

PROVIDER: S-EPMC9520400 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature