What are the ethical considerations specific to open-label extension studies where a placebo group transitions to active treatment?

Open-label trial ... An open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants. ... In particular ... Sep 17, 2024 ... ... Open-Label Trial in Patients with Newly Diagnosed Oligometastatic Prostate Cancer Starting ADT ... The STAMPEDE2 trial is a phase III, randomized, ... Mar 29, 2019 ... Conclusion: ECLM administration to the pediatric patients with refractory epilepsy contributed to improvement of epileptic manifestation and ... Mar 2, 2018 ... An open label trial of folate receptor-targeted intraoperative molecular imaging to localize pulmonary squamous cell carcinomas. Jarrod D ... A5384 is a trial for people who have or might have tuberculous meningitis (TBM). TBM is an infectious disease that causes inflammation of the membranes that ... Methods: This Phase 4, multicenter, open label study included patients with uncontrolled gout (SU ≥6 mg/dL, oral urate-lowering therapy intolerance/inefficacy, ... Jun 10, 2011 ... An Open-Label Trial of Risperidone in Children and Adolescents with Severe Mood Dysregulation. Authors: Fernanda Valle Krieger, Gabriel ... Jul 31, 2024 ... The main aim is to test how safe and effective the medicine ILUVIEN® (190μg) is for children and adolescents, who have non-infectious ... 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 ... Oct 3, 2023 ... ENVOL is an open-label, single-arm, two-part study to evaluate the safety and transduction efficiency of systemic gene therapy with commercial ...