Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceuti...
When discussing potential entry by a patient with cancer into a therapeutic clinical trial, it is essential that the potential risks and benefits, the knowns and unknowns, are carefully and clearly described, and all questions are answered to the best of the clinician’s/investiga...
Furthermore, phase 3 studies often do not note the proportion of all patients who although eligible were not enrolled; such potential 'selection bias' makes it plausible results are not applicable to many patients seen in clinical practice [4]. It remains possible that, even if unpredictable, ...
In the context of targeted therapies and the imperative patient stratification, this implies that future phase II clinical trials should be performed according to the prior detection of STAT3 Y705 phosphorylation on biopsies. STAT3 inhibitors, or drugs that are targeting this pathway, should not be ...
Therefore, if phase II clinical trials are conducted to inactivate the STAT3 oncogene in breast cancer, different subtypes of this disease should not be treated with the same drugs. Different STAT3-targeting drugs may also be used to treat tumors expressing the Ras or ...
clearance. These drugs are currently undergoing phase II clinical trials for the treatment of diseases involving mitochondrial oxidative damage, such as AD and other neurodegenerative diseases [148]. Synaptic loss as an implication of neuroinflammation in AD...
outcomes, we compared the transcriptional profiles associated with drug resistance variants with those identified in single-cell RNA sequencing of patient tumors (n = 23) from a recent phase-two clinical study of a BRAF, MEK and PD-1 inhibitor combination in patients with BRAF V600E CRC28...
A phase II dose-validation study with dabigatran was performed in such patients. This is the only intervention trial performed so far with an NOAC in patients with a mechanical prosthetic valve (only 23% of whom had AF), and included patients with implantation within the past 7 days of a ...
we tested the validity of our score in another prospective clinical trial conducted by the Chinese Thoracic Oncology Group (CTONG), the EMERGING-CTONG1103 trial, a multicenter phase II neoadjuvant study that enrolled patients with EGFR-mutant stage IIIA-N2 NSCLC33. As neoadjuvant treatment mainly co...
The drug was created by Tanox under the name TNX-650, and a phase I clinical trial for refractory Hodgkin’s lymphoma had been p Lebrikizumab (旅店) 是一个被赋予人性的单克抗体和一种实验性immunosuppresive药物为不可能充分地控制与可吸入的glucocorticoids哮喘的治疗。 药物是由Tanox创造的以TNX-650...