News & Events

• 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.

  Link to article: https://www.contemporaryclinicaltrials.com/article/S1551-7144(20)30040-9/fulltext

• March 19, 2020
  

  C-Path Receives FDA Grant to Establish Rare Disease Clinical Outcome Assessment Consortium

  The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research has funded a cooperative agreement to establish a Rare Disease Clinical Outcome Assessment Consortium. The grant was awarded to C-Path with the NORD as a sub-awardee. The first step taken toward the establishment of the new consortium has been the creation of the Rare Disease Subcommittee within C-Path’s Patient-Reported Outcome (PRO) Consortium.

• March 18, 2020
  

  C-Path and Lundbeck Announce a Data Sharing Collaboration to Enable Development of Advanced Drug Development Tools in Alzheimer’s Disease

  C-Path and H. Lundbeck A/S are proud to announce that they will work together to significantly improve the scientific community’s insight in Alzheimer’s disease through Lundbeck’s contribution of a unique set of clinical trial data from more than 2,500 AD patients to the Critical Path for Alzheimer’s Disease consortium’s integrated database for qualified researchers across the globe to access.

• March 17, 2020
  

  C-Path to Lead Multi-Stakeholder Engagement on FDA’s Proposed Novel Framework to Enhance the Pediatric Medical Device Ecosystem

  C-Path today announced it has been awarded a grant to conduct stakeholder engagement to garner insights, feedback and refinement of the FDA Center for Devices and Radiological Health’s proposed framework to enhance the pediatric medical device ecosystem and to develop a strategic plan for implementation.

• March 12, 2020
  

  C-Path Appoints Dr. Klaus Romero as Chief Science Officer

  The Critical Path Institute (C-Path) today announced the appointment of Klaus Romero, M.D., M.S., F.C.P., as its new Chief Science Officer (CSO) effective April 1, 2020. Dr. Romero, a clinical pharmacologist and epidemiologist with more than 17 years combined experience in academic and pharmaceutical clinical research, translational sciences, pharmacometrics, modeling and simulation and pharmacoepidemiology, has been with C-Path since December 2007. His most recent role has been as Executive Director of Clinical Pharmacology and Quantitative Medicine. He will continue in dual roles as CSO and head of the Quantitative Medicine Program.