News & Events

• April 29, 2020
  

  C-Path ePRO Consortium and PRO Consortium Announce COVID-19 Risk Assessment and Mitigation Strategies

  In collaboration with Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium, the Electronic Patient-Reported Outcome (ePRO) Consortium announces “Coronavirus Disease 2019 (COVID-19): Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome Data through Clinical Sites.” The 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 clinical trial sites. Recommended risk assessment and mitigation strategies are provided for consideration by trial sponsors and electronic clinical outcome assessment (eCOA) providers to facilitate the continued collection of PRO data in clinical trials.

• 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.

  Access the PDF: COVID-19: Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome Data through Clinical Sites

• 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.

• April 9, 2019
  

  C-Path Receives Qualification from FDA for the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD)

    TUCSON, Ariz., April 9, 2019 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces U.S. Food and Drug Administration (FDA) qualification of two new clinical outcome assessment tools: the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD). The qualification of the ADSD and the ANSD represents a major milestone...
• May 7, 2018
  

  C-Path Receives COA Qualification from FDA for the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

    TUCSON, Ariz. – May 7, 2018 — Critical Path Institute‘s (C-Path) Patient-Reported Outcome (PRO) Consortium announces its second clinical outcome assessment (COA) qualification from the US Food and Drug Administration (FDA). The qualification of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) for exploratory use represents another major milestone for the PRO Consortium and,...