Harriet Gray Stephens

Aug 14, 2024 | clinicalleader.com | Harriet Gray Stephens |Edward Groleau |Dan Schell |J.C. Wilson

The Pros And Cons Of Synthetic Control Arms In Clinical TrialsExplore how synthetic control arms (SCAs) are being used in clinical trials, the views of regulators, and the advantages and limitations of SCAs in practice. Strengthening Pathways For Cell And Gene TherapiesThis report aims to spur informed discussions on the future trajectory of cell and gene therapies and their pivotal role in shaping the future of healthcare.

Jul 8, 2024 | clinicalleader.com | Harriet Gray Stephens

By Harriet Gray Stephens, MFPM, medical director, Boyds Synthetic control arms (SCAs) are an innovative approach that is increasingly being adopted in clinical trials and a type of external control arm study. External controls have been defined by the FDA as any control group that is not a part of the same randomized study as the group receiving the investigational therapy.

Sep 27, 2023 | insights.bio | Harriet Gray Stephens

Cell & Gene Therapy Insights 2023; 9(9), 1111–1116 10.18609/cgti.2023.147 Harriet Gray Stephens Please enter your email to access content Please note all fields marked with an * are mandatory Title* Country* Please select which journals you are interested in: Cell and Gene Therapy Insights Immuno-Oncology Insights Vaccine Insights Please select your areas of interest: Drug Delivery Public Health Bioanalytics Manufacturing Vectors Analytical/QA/QC/CMC Business Development/Licensing/Finance...