News & Events
News & Events
- April 27, 2020
April 21, 2020
C-Path Awarded FDA Contract to Enhance the Assessment of Clinical Outcomes in Pediatric Asthma Treatment Trials
The Critical Path Institute (C-Path) announced today it has been awarded a U.S. Food and Drug Administration (FDA) contract in support of ongoing development of novel clinical outcome assessments for pediatric asthma. C-Path’s Patient-Reported Outcome (PRO) Consortium will carry out this work through its Pediatric Asthma Working Group. Specifically, these assessments are intended to facilitate innovative patient-focused drug development and aid regulatory decision making by filling an unmet measurement gap.
April 10, 2020
ePRO Consortium Announces COVID-19 Risk Assessment and Mitigation Strategies for Sponsors and eCOA Providers for Collection of PRO Data through Clinical Sites
In collaboration with C-Path’s PRO Consortium, the ePRO Consortium has developed the presentation titled “Coronavirus Disease 2019 (COVID-19): Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome (PRO) Data through Clinical Sites.” This presentation focuses on the current challenges of capturing PRO data originally intended to be collected electronically (i.e., ePRO) from study participants during in-person visits to study sites. Recommended risk assessment and mitigation strategies for consideration by trial sponsors and eCOA providers to facilitate the continued collection of PRO data in clinical trials are provided.
March 30, 2020 - March 31, 2020
POSTPONED: 2020 DIA Digital Technology in Clinical Trials ConferenceThe ePRO Consortium is pleased to be a co-sponsor of the upcoming 2020 DIA Digital Technology in Clinical Trials Conference to be held from March 30-31, 2020 in Boston, MA. This multi-track conference will bring together thought-leaders from regulatory agencies, biotech, pharmaceutical, patients, and academia to discuss the latest advances, challenges, and forward-thinking approaches for...
March 26, 2020
ePRO Consortium Announces Open Access Article
In collaboration with the DIA Study Endpoints Community, C-Path’s ePRO Consortium is pleased to announce the open access article “Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials” is available online in the April 1, 2020 issue of Contemporary Clinical Trials. This article provides recommendations for the structure and content of an evidence dossier aimed at supporting a clinical trial endpoint derived from mobile sensor data as fit-for-purpose in regulatory decision making.