How do regulatory agencies view historical control data in the context of open-label trials?

Study protocol; Open access; Published: 23 June 2020. ENG-releasing subdermal implants in postpartum teenagers – an open-label trial study protocol. This is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects ... Sep 17, 2024 ... Sarah Howlett discussing the trial design of STAMPEDE2, a phase 3, randomized, open-label trial of niraparib-abiraterone acetate + prednisolone ... Nov 17, 2020 ... We conducted a prospective, randomized, open-label, multicenter trial of favipiravir for the treatment of COVID-19 at 25 hospitals across Japan. Study design. CONSERVE was a 1:1 randomized, controlled, open-label, international, multicenter trial at 22 hospitals and cardiology practices in North America, ... Mar 8, 2021 ... The findings show that treating COVID-19 patients with an injection of 100 milligrams of anakinra for ten days may be an effective approach because the drug ... Nov 9, 2023 ... Conclusions. These findings suggest that prescribed medical cannabis may have minimal acute impact on cognitive function among patients with ... 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 ... Jan 8, 2020 ... The purpose of this research study is to analyze the treatment potential of tofacitinib in patients with sarcoidosis that involves the skin. Jan 17, 2025 ... ... trial with randomized controlled treatment group assignment, open-label treatment, and blinded core laboratory outcome evaluation. This study ...