Track topics on Twitter Track topics that are important to you
Sinovant Sciences Announces Approval Derazantinib Clinical Trial Application PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Sinovant Sciences Announces Approval Derazantinib Clinical Trial Application articles that have been published worldwide.
We have published hundreds of Sinovant Sciences Announces Approval Derazantinib Clinical Trial Application news stories on BioPortfolio along with dozens of Sinovant Sciences Announces Approval Derazantinib Clinical Trial Application Clinical Trials and PubMed Articles about Sinovant Sciences Announces Approval Derazantinib Clinical Trial Application for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Sinovant Sciences Announces Approval Derazantinib Clinical Trial Application Companies in our database. You can also find out about relevant Sinovant Sciences Announces Approval Derazantinib Clinical Trial Application Drugs and Medications on this site too.
Numerous studies across multiple specialties have evaluated the impact of trial registration on quality of study reports and found significant improvements over several domains. However, the impact of mandatory trial registration on the quality of clinical trial protocols remains hitherto unexplored.
Novel cancer therapies are often approved with evidence from a single pivotal trial alone. There are concerns about the credibility of this evidence. Higher validity may be indicated by five methodological and statistical characteristics of pivotal trial evidence that were described by the US Food and Drug Administration (FDA) which may corroborate the reliance on a single trial alone for approval decisions.
Clinical trials consume the latter half of the 10 to 15 year, 1.5-2.0 billion USD, development cycle for bringing a single new drug to market. Hence, a failed trial sinks not only the investment into the trial itself but also the preclinical development costs, rendering the loss per failed clinical trial at 800 million to 1.4 billion USD. Suboptimal patient cohort selection and recruiting techniques, paired with the inability to monitor patients effectively during trials, are two of the main causes for high...
One of the most challenges for rare disease clinical trials is probably the availability of a small patient population. It is then a great concern on how to conduct clinical trials with a small number of subjects available for obtaining substantial evidence regarding safety and effectiveness for approval of the rare disease drug product under investigation. FDA, however, does not have the intention to create a statutory standard for approval of orphan drugs that are different from the standard for approval ...
The aim of this randomized, three-arm parallel, single-blinded clinical trial was to evaluate the clinical and microbiological effectiveness of the ozone application in two-visit indirect pulp therapy.
This randomized triple-blind clinical trial, split-mouth design, evaluated the application effect of the desensitizing gel before and after in-office bleaching on tooth sensitivity.
Toripalimab, a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2), is being developed by Shanghai Junshi Bioscience Co., Ltd in China for the treatment of various cancers. In December 2018, based on positive efficacy results of a phase 2 trial and safety data from several clinical studies, toripalimab received conditional approval in China for the treatment of unresectable or meta...
In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.
This review characterizes clinical development that supported the label dose in 60 drug indications recently approved by the US Food and Drug Administration. With Lewis B. Sheiner's Learning vs. Confirming clinical drug development paradigm as a reference point, the clinical development paths, the design of dose-ranging trials, and the dose-exposure-response characterization were examined using US Food and Drug Administration approval packages. It was found that 89% of clinical development programs included...
Romosozumab (EVENITY™) is a humanised monoclonal antibody against sclerostin being developed by Amgen and UCB for the treatment of osteoporosis. On the basis of favourable results from several phase III trials in postmenopausal women with osteoporosis, and a single trial in men with osteoporosis, romosozumab is being considered for marketing approval in the US, EU and Canada, and was recently approved for marketing in Japan. This article summarizes the milestones in the development of romosozumab leading ...
The Food and Drug Administration (FDA) and European Medicines Agency (EMA) have robust scientific and technical collaborations. As a window to the impact of these activities we compared the agencies' decisions on drug marketing applications. Decisions were compared for 107 new drug applications with a regulatory outcome at both agencies in the period 2014 to 2016. Further analysis addressed individual applications for which the agencies had differing outcomes in terms of marketing approval, type of approval...
Clinical trial registries are intended to increase clinical research transparency by nonselectively identifying and documenting clinical trial designs and outcomes. Inconsistencies in reported data undermine the utility of such registries and have previously been noted in general medical literature.
The aim of this randomized, controlled, prospective clinical trial was to evaluate the performances of two different universal adhesives and one etch-rinse adhesive for restoration of non-carious cervical lesions (NCCLs).
Sodium alendronate (ALN) is an aminobisphosphonate and potent inhibitor of bone resorption. It has been suggested that ALN might be a promising carrier of biomolecules for periodontal bone repair. The aim of this randomized split-mouth clinical trial was to evaluate the effects of the topical application of 1% ALN gel in intrabony defects during the surgical treatment of patients with periodontitis.
Many targeted therapies are currently available only via clinical trials. Therefore, routine precision oncology using biomarker-based assignment to drug depends on matching patients to clinical trials. A comprehensive and up-to-date trial database is necessary for optimal patient-trial matching.
Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios-series of trials th...
This opinion paper aims at discussing the deluge of meta-analyses in current health sciences, and the publication of seven different ones covering diverse topics in nutrition sciences in the December issue of Clinical Nutrition. Several key aspects are raised regarding this type of study with the goal of raising awareness among clinicians who rely on these studies to summarize what they assume it is the best evidence towards application to patient care.
Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and us...
The age-related decline in mass, strength and performance of skeletal muscle is associated with loss of independence, falls risk, disability, institutionalization and death.
Barriers to cancer clinical trial participation have been the subject of frequent study, but the rate of trial participation has not changed substantially over time. Studies often emphasize patient-related barriers, but other types of barriers may have greater impact on trial participation. Our goal was to examine the magnitude of different domains of trial barriers by synthesizing prior research.
The US Food and Drug Administration (FDA) created the exception from informed consent (EFIC) pathway in 1996 to allow some emergency trials to enroll patients without informed consent. To protect individual autonomy and preserve public trust, the FDA requires that EFIC trial investigators consult with community members before a trial may begin.
The aim of this split-mouth, triple-blind, randomized clinical trial was to evaluate the long-term clinical efficacy of experimental potassium oxalate concentration (10%) in relieving dentin hypersensitivity (DH), after a four-session application protocol.
We discuss the multivariate (2L-variate) correlation structure and the asymptotic distribution for the group-sequential weighted logrank statistics formulated when monitoring two correlated event-time outcomes in clinical trials. The asymptotic distribution and the variance-covariance for the 2L-variate weighted logrank statistic are derived as available in various group-sequential trial designs. These methods are used to determine a group-sequential testing procedure based on calendar times or information ...
"Target trial emulation" has been proposed as an observational method to answer comparative effectiveness questions, but it has rarely been attempted concurrently with a randomized clinical trial (RCT).
Off-label testosterone prescribing for androgen deficiency (AD)-like sexual and energy symptoms of older men without pathologic hypogonadism has increased dramatically without convincing evidence of efficacy.