Newsletter - February 15, 2024
Charging Patients for Participating in a Clinical Trial? FDA Clarifies Conditions
Clinical trial sponsors are responsible for paying for the cost of conducting the trial which includes paying for the use of clinics, hiring staff or vendors to manage the trial, collection and review of the data, regulatory approvals, and anything else that may be needed to properly run the trial. In some specific circumstances...Read More
FDA Updates Guidance for Data Monitoring Committees
Since its first Guidance Document for Data Monitoring Committees (DMCs) in 2006, the role of DMCs in clinical trial and clinical development programs has expanded exponentially. Sponsors frequently debate the purpose, scope, and limitations of DMCs which in turn increases the time and cost to set-up these and creates...Read More
Charging Patients for Participating in a Clinical Trial? FDA Clarifies Conditions
Clinical trial sponsors are responsible for paying for the cost of conducting the trial which includes paying for the use of clinics, hiring staff or vendors to manage the trial, collection and review of the data, regulatory approvals, and anything else that may be needed to properly run the trial. In some specific circumstances...Read More
FDA Updates Guidance for Data Monitoring Committees
Since its first Guidance Document for Data Monitoring Committees (DMCs) in 2006, the role of DMCs in clinical trial and clinical development programs has expanded exponentially. Sponsors frequently debate the purpose, scope, and limitations of DMCs which in turn increases the time and cost to set-up these and creates...Read More