How do different regulatory agencies weigh the evidence from open-label trials?

MISSION: A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma and ... Acthar® Gel (repository corticotropin injection) is FDA-approved for treatment of acute episodes or exacerbation of PsA, but no clinical trials have ... Oct 30, 2019 ... The study included children aged between 8 and 17 years, with moderate to severe psoriasis, given tofacitinib 5 mg orally twice daily for at least 36 weeks. Jun 17, 2023 ... Treatment with amikacin liposome inhalation suspension (ALIS) improve culture conversion in patients with M abscessus pulmonary disease. Jul 9, 2021 ... Phase 1b open-label trial of afatinib plus Xentuzumab (BI 836845) in patients with EGFR mutation-positive NSCLC after progression on EGFR tyrosine kinase ... 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 ... Apr 8, 2014 ... Multicentre, Randomised, Open-Label Trial To Compare Efficacy And Tolerance Of Prednisone And IVIG In Patients With CIDP On A One Year Follow Up ... 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 ... Nov 9, 2023 ... Conclusions. These findings suggest that prescribed medical cannabis may have minimal acute impact on cognitive function among patients with ... Triheptanoin dramatically reduced by 90% the number of non-epileptic paroxysmal manifestations over 2 months in GLUT1-DS and improved patient's brain energy ...