What is the role of post-marketing surveillance in evaluating the long-term safety and effectiveness of drugs initially studied in open-label trials?

A randomized, multicenter, open-label trial to determine peritonitis rate, product defect, and technique survival between ANDY-Disc® and UltraBag® in patients ... Nov 9, 2020 ... A randomized, open-label controlled trial of oral favipiravir in adults hospitalized with moderate to severe COVID-19 pneumonia from June 22nd 2020 to August ... A randomized, open-label, clinical trial examined the effects of canagliflozin on albuminuria and eGFR decline using an individual pre-intervention eGFR slope. Treating Foot Infections in Diabetic Patients: A Randomized, Multicenter, Open-Label Trial of Linezolid versus Ampicillin-Sulbactam/Amoxicillin-Clavulanate. A randomised controlled open label trial examining the safety of label-recommended semaglutide 1mg dose escalation vs a slower and flexible titration regimen. A multicenter, single-arm, open-label trial of birociclib, a CDK4/6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast ... Jan 17, 2025 ... ... trial with randomized controlled treatment group assignment, open-label treatment, and blinded core laboratory outcome evaluation. This study ... Open-label studies lack the rigor of blinded studies. Since the lack of blinding can introduce significant bias, reserve the use of open-label studies for ... Study #2024-1042. A Phase II multicenter open-label trial of tagraxofusp (Tag) in combination with venetoclax and azacitidine (Ven/Aza) in adults with ... We describe two randomised trials where blinded outcome assessment was not possible, and discuss the strategies used to reduce the possibility of bias.