News & Events

• March 9, 2021
  

  C-Path Receives FDA Qualification for the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C)

  TUCSON, Ariz., March 9, 2021 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces the qualification of the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) by the U.S. Food and Drug Administration (FDA). The DIBSS-C was developed by the PRO Consortium’s Irritable Bowel Syndrome (IBS) Working Group to support symptom-based efficacy endpoints in clinical trials for products intended to treat constipation-predominant IBS (IBS-C) in adults. Qualification of the DIBSS-C represents a major milestone for the IBS Working Group and is the PRO Consortium’s fourth clinical outcome assessment (COA) to be qualified through the COA Qualification Program within FDA’s Center for Drug Evaluation and Research.

• January 7, 2021
  

  Diary for Irritable Bowel Syndrome Symptoms-Constipation is the First Patient-Reported Outcome Consortium Measure Used to Support an FDA-approved Label Claim

  TUCSON, Ariz., January 7, 2021 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces that clinical study results using the Consortium’s Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) were recently included in the expanded label for the drug LINZESS^® (linaclotide). The DIBSS-C was developed by the PRO Consortium’s Irritable Bowel Syndrome (IBS) Working Group to support the evaluation of both primary and key secondary endpoints related to improvements in IBS-C signs and symptoms within the context of clinical trials and is currently in FDA’s Clinical Outcome Assessment Qualification Program. Although the DIBSS-C was not specifically mentioned, results from its abdominal symptom scale were included in the updated label for LINZESS^®. This is the first time a PRO Consortium measure has been used to support a label claim.

• September 21, 2020
  

  C-Path Awarded FDA Drug Development Tool Research Grant to Develop a Qualification Plan for the Symptoms of Major Depressive Disorder Momentary Assessment (SMDDMA)

  C-Path’s Patient-Reported Outcome (PRO) Consortium announced that it has been awarded a U.S. Food and Drug Administration (FDA) Drug Development Tool Research Grant in support of the qualification of the Symptoms of Major Depressive Disorder Momentary Assessment (SMDDMA) as a self-reported measure of symptom severity in individuals diagnosed with major depressive disorder (MDD). C-Path’s PRO...
• September 3, 2020
  

  C-Path Awarded FDA Drug Development Tool Research Grant to Develop a Qualification Plan for the PROMIS^® Short Form v2.1—Physical Function-Multiple Sclerosis 15a (PROMIS PFMS—15a)

    C-Path’s Patient-Reported Outcome (PRO) Consortium announced today it has been awarded a U.S. Food and Drug Administration (FDA) Drug Development Tool Research Grant in support of the qualification of the PROMIS® Short Form v2.1—Physical Function-Multiple Sclerosis 15a (PROMIS PFMS—15a) as a self-reported measure of physical function in individuals diagnosed with all forms of multiple...
• 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.