News & Events
-
April 26, 2017 - April 27, 2017
Eighth Annual Patient-Reported Outcome Consortium Workshop
April 26 – 27, 2017 Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814 On April 26-27, 2017 the EIGHTH ANNUAL PATIENT-REPORTED OUTCOME CONSORTIUM WORKSHOP was held in Bethesda, Maryland. The overall Workshop objectives were to: • Provide an update on FDA’s Clinical Outcome Assessment (COA) Qualification Program; • Describe progress within the PRO... -
April 25, 2017
Second Annual Workshop On Clinical Outcome Assessments In Cancer Clinical Trials
Assessing Tolerability of Cancer Treatments: Optimizing the Role of Patient-Reported Data April 25, 2017 Hyatt Regency Bethesda 1 Bethesda Metro Center Bethesda, MD 20814 CO-SPONSORED BY: Critical Path Institute U.S. Food and Drug Administration Workshop Agenda 7:30-8:15 am Registration and Continental Breakfast – Regency I and II 8:15-8:30 am Welcome and Opening RemarksPaul G. Kluetz,... -
April 20, 2017
Development of the Diary for Irritable Bowel Syndrome Symptoms (DIBSS) to Assess Treatment Benefit in Clinical Trials: Foundational Qualitative Research
Fehnel S, Ervin C, Carson R, Rigoni G, Lackner J, Coons SJ, et al. Development of the Diary for Irritable Bowel Syndrome Symptoms (DIBSS) to Assess Treatment Benefit in Clinical Trials: Foundational Qualitative Research. Value in Health. 20(4):618–26.
-
April 18, 2017
CDISC Announces New Standard for Major Depressive Disorder to Foster Development of New Treatments
April 18, 2017 CDISC Announces New Standard for Major Depressive Disorder to Foster Development of New Treatments Austin, TX – 18 April 2017 – The Clinical Data Interchange Standards Consortium (CDISC) today announced the release of Major Depressive Disorder (MDD) Therapeutic Area User Guide v1.0. The MDD standard is freely available on the CDISC... - April 18, 2017
