What are the strengths and weaknesses of relying solely on open-label data for regulatory approval?

Oct 22, 2024 ... An open trial is a study design where participants and researchers are not blinded to the experiment (Sedgwick, 2014) . All the procedures were ... A seven-week, open-label trial evaluating the safety and efficacy of a photopneumatic device for mitigating mild-to-moderate acne in healthy adolescents and ... Jan 4, 2024 ... Participants were randomly assigned to treatment with the glucagon-like peptide 1 receptor agonist semaglutide or the sodium–glucose cotransporter 2 inhibitor ... Aug 3, 2022 ... Methods: In this open-label trial, 31 young people aged 12–25 years with a DSM-5 anxiety disorder and no clinical improvement despite treatment ... Abstract. Many oncology clinical trials are randomized open-label trials. In order to minimize operational bias while not hindering critical activities in ... Dec 1, 2023 ... Neurona Therapeutics Presents New Clinical Data from First Cohort in Ongoing Phase I/II Open-Label Trial of NRTX-1001 Cell Therapy for Drug- ... If you receive at least 1 dose of RYZ801, you will enter the Long-Term Follow-Up period following the Study Treatment Stage. During Long-Term Follow-Up, you ... (143) - Multicenter Open-Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics (PK) of Tacrolimus Inhalational Powder as a Replacement ... 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 ... Study #2024-1042. A Phase II multicenter open-label trial of tagraxofusp (Tag) in combination with venetoclax and azacitidine (Ven/Aza) in adults with ...