What are the ethical considerations related to offering all participants the active treatment in an open-label extension?

Abstract. Many oncology clinical trials are randomized open-label trials. In order to minimize operational bias while not hindering critical activities in ... The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure ... Nov 2, 2023 ... Interim Analyses from the Beacon Trial: A Phase 2, Randomized, Open-Label Trial of Bitopertin in Erythropoietic Protoporphyria. Gayle Ross ... Jun 5, 2022 ... This study aimed to monitor the neuropsychiatric part of IBS and its management, following the quality of life of patients with IBS. 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- ... An open-label randomised-controlled trial of azathioprine vs. mycophenolate mofetil for the induction of remission in treatment-naive autoimmune hepatitis. 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. Addition of primaquine to artemisinin combination treatment did not improve elimination of parasitaemia and prevention of gametocyte carriage. The objective of this investigation is to assess the efficacy of coenzyme Q10 as a preventive treatment for migraine headaches. (143) - Multicenter Open-Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics (PK) of Tacrolimus Inhalational Powder as a Replacement ...