Publications

• October 10, 2014
  

  Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, And Promise Of ePRO Measurement In Clinical Trials

• September 14, 2014
  

  The Patient-Reported Outcome (PRO) Consortium Lessons Learned Along the Path to PRO Instrument Qualification

  Hayes RP, Blum SI, Gordon MF, Piault E, Burke LB, Slagle AF, Coons SJ. The Patient-Reported Outcome (PRO) Consortium Lessons Learned Along the Path to PRO Instrument Qualification. Therapeutic Innovation & Regulatory Science. 2015;49(1):132–8.

   

• July 5, 2014
  

  PRO Data Collection in Clinical Trials Using Mixed Modes: Report of the ISPOR PRO Mixed Modes Good Research Practices Task Force

• July 1, 2014
  

  Coalition Against Major Diseases/European Medicines Agency Biomarker Qualification Of Hippocampal Volume For Enrichment Of Clinical Trials In Predementia Stages Of Alzheimer’s Disease

• April 28, 2014
  

  Nonclinical Safety Biomarkers of Drug-induced Vascular Injury: Current Status and Blueprint for the Future

  Mikaelian I, Cameron M, Dalmas DA, Enerson BE, Gonzalez RJ, Guionaud S, Hoffmann PK, King NMP, Lawton MP, Scicchitano MS, Smith HW, Thomas RA, Weaver JL, Zabka TS, and The Vascular Injury Working Group of the Predictive Safety Consortium. Nonclinical Safety Biomarkers of Drug-Induced Vascular Injury: Current Status and Blueprint for the Future. Toxicologic Pathology. 2014 Jun 1;42(4):635–57.