Does the regulatory approval process differ for drugs evaluated in open-label versus blinded trials?

Mar 4, 2025 ... Inclusion Criteria: ... Unresponsive to ≥2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last 12 months. BCG-unresponsive refers to ... May 29, 2024 ... Infusion of mbIL-7-TIL has acceptable safety and potent efficacy in recurrent OC patients who have limited treatment options. May 23, 2014 ... Open label trials are sometimes referred to as “non-masked” or “unblinded.” If the trial is a non-pharmacological study, such as a trial of ... Mar 4, 2018 ... An exploratory time-varying product-adherence analysis in which adherence was defined as a residual level of 21 mg or less of dapivirine in the ... Study design. CONSERVE was a 1:1 randomized, controlled, open-label, international, multicenter trial at 22 hospitals and cardiology practices in North America, ... Jan 17, 2025 ... ... trial with randomized controlled treatment group assignment, open-label treatment, and blinded core laboratory outcome evaluation. This study ... We describe two randomised trials where blinded outcome assessment was not possible, and discuss the strategies used to reduce the possibility of bias. Apr 20, 2023 ... Open-label clinical trials are appropriate when randomization of treatments may be difficult, or if it's important to test long-term effects or safety profiles. Eligibility Requirements. Inclusion Criteria. Subjects must meet all the following criteria for enrollment in the study: - Eastern Cooperative Oncology Group ... Jun 10, 2011 ... An Open-Label Trial of Risperidone in Children and Adolescents with Severe Mood Dysregulation. Authors: Fernanda Valle Krieger, Gabriel ...