In this issue of Annals of Neurology, Pittock and colleagues report the primary outcome of a phase 3 clinical trial of ravulizumab for aquaporin-4-positive neuromyelitis optica spectrum disorder (NMOSD). Ravulizumab is a second-in-class terminal complement inhibitor; like the firstgeneration ...
The phase I trial of SNS-032 is a dose-escalation study designed to evaluate the safety and tolerability, as well as the preliminary anti-tumor activity of the agent in patients with advanced B-cell malignancies. The trial will also be used to determine the maximum tolerated does in this se...
The ethical issue at the core of clinical research is whether the research's outcome can reasonably be expected to benefit society without harming the individuals enrolled in the trial. Respect for persons is embodied in informed consent, which dictates that information be exhaustive and provided ...
Diabetes prevention in the Caribbean using Lifestyle Intervention and Metformin Escalation (LIME): Protocol for a hybrid Type-1 effectiveness-implementation trial using a quasi-experimental study design Saria Hassan, Natasha Sobers, Joanne Paul-Charles, Joseph Herbert, ... Marcella Nunez-Smith ...
“Do no harm” is applicable because the participants' fates are influenced by therandomization. Clinician judgment as to the individual's optimal treatment must explicitly be set aside. The stakes are always high when a trial is underway. We want a result quickly and definitively, but the two...
[219]. A phase Ia dose-escalation trial, the combination of PHI-101 (a selective CHK2 inhibitor) with a PARPi showed good safety and tolerability, and is a potential therapeutic regimen for platinum-resistant recurrent ovarian cancer [220]. In summary, the therapeutic efficacy and underlying ...
Despite current advances in clinical trial design and analysis, examples of drug failures after lengthy and expensive development processes can still be fo
J. et al. Combined immunotherapy with granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells and ipilimumab in patients with metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol. 13, 509–517 (2012). Article CAS PubMed ...
Clinical trial results with oncolytic virotherapy: a century of promise, a decade of progress Abstract Therapeutic oncolytic viruses (virotherapeutics) constitute a novel class of targeted anticancer agents that have unique mechanisms of action compared with other cancer therapeutics. The development of ...
May 2025Volume 45, Issue 5 Latest articles Risk of Osteoarthritis and Arthroplasty Between Baclofen and Tizanidine: A Target Trial Emulation Study Yu-Chi Su Yu-Chen Su Yu-Ching Lin Original Research Article19 May 2025 Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Axatilimab in Hea...