Services

Identifying Patient Experiences

Understanding what patient experiences are most relevant is a critical first step in choosing or developing a clinical outcome assessment.
Clinical Outcome Assessment Selection and Development

Once the key patient experiences in a therapeutic area have been identified, an instrument can be selected or developed to measure them.
Endpoint Strategy Support

Establishing an effective endpoint strategy requires more than the selection or development of an acceptable measure.

Documentation and Meeting Support

Clear communication of clinical outcome assessment data is required when meeting with regulatory and payer stakeholders.
Publication and Presentation Support

Writing manuscripts that include patient interview or clinical outcome assessment data requires specialized technical skills.
Contact Uswebsite@gwaltneyconsulting.com



Publications
Validation of the PRUCISION Instruments in Pediatric Patients with Progressive Familial Intrahepatic Cholestasis
Advances in Therapy
Reliability and Validity of an Instrument of COVID-19 Patient-Reported Symptoms in Outpatients
JAMA Network Open
Composite Endpoint to Evaluate Complement Inhibition Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria
European Journal of Haematology
Living with Heart Failure: Patient Experiences and Implications for Physical Activity and Daily Living
ESC Heart Failure
Fabry Disease Patient-Reported Outcome (FD-PRO) Demonstrates Robust Measurement Properties for Assessing Symptom Severity in Fabry Disease
Molecular Genetics and Metabolism Reports


About

Chad Gwaltney, Ph.D. is President and Principal Consultant at Gwaltney Consulting. Dr. Gwaltney develops innovative methods to measure patient-centered outcomes in clinical trials. His academic and industry research includes the design of electronic platforms for the collection of information in real-time in the patient’s natural environment. He has published numerous articles and book chapters addressing how the patient’s perspective can be examined to better understand medical product efficacy and safety. He has served on US National Institutes of Health review committees and has co-authored ISPOR best practice guidelines on the development and use of patient-reported outcomes. Prior to founding Gwaltney Consulting, Dr. Gwaltney was Chief Scientist and Regulatory Advisor, Endpoints, at ERT. Dr. Gwaltney has also served as Head, Patient Experience, Hematology/Oncology, at Celgene and as a research faculty member in the Brown University School of Public Health.