News & Events
July 30, 2020
C-Path Partners with CHDR to Expand Global CollaborationsThe Critical Path Institute and the Centre for Human Drug Research (CHDR) have joined forces to expand global collaborations for both organizations. The initiative brings together stakeholders from each side with the objective of increasing actionable solutions for drug development and public health. The partnership allows CHDR to become involved in other areas of interest......
June 11, 2020
From the Regulatory Affairs Professional Society (RAPS): FDA’s CURE ID app gets a COVID-19 refresh
An online case reporting platform has been optimized for COVID-19 and will be the springboard for a new public-private drug repurposing collaboration.
The CURE ID online platform was developed to allow clinicians to report off-label uses of drugs to treat infectious diseases, with the goal of generating hypotheses for further study of difficult-to-treat infectious diseases. The internet repository of these cases can also be accessed by clinicians and other users, with the option to view aggregated datasets as well as the individual case reports. The platform can be used via a computer browser or Apple and Android-based smartphone apps. Full article here.
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 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.
December 2, 2019
Workshop Summary, Advancing the Development and Implementation of Analysis Data Standards, Now AvailableC-Path is proud to announce the availability of the workshop summary, Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities. The workshop, in collaboration with the Duke-Margolis Center for Health Policy and the Food and Drug Administration (FDA), was planned with the support of C-Path data standard expertise, and included a......