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PubMed Journals Articles About "Sinovant Sciences Announces Approval Derazantinib Clinical Trial Application" RSS

20:04 EDT 15th September 2019 | BioPortfolio

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Showing "Sinovant Sciences Announces Approval Derazantinib Clinical Trial Application" PubMed Articles 1–25 of 41,000+

Methodological Characteristics of Clinical Trials: Impact of Mandatory Trial Registration.

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.


Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies.

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.

Artificial Intelligence for Clinical Trial Design.

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...


Statistical considerations for rare diseases drug development.

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 ...

Effectiveness of the ozone application in two-visit indirect pulp therapy of permanent molars with deep carious lesion: a randomized clinical trial.

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.

Bleaching-induced tooth sensitivity with application of a desensitizing gel before and after in-office bleaching: a triple-blind randomized clinical trial.

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: First Global Approval.

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...

Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow.

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.

Dose Finding in the Clinical Development of 60 US Food and Drug Administration-Approved Drugs Compared With Learning vs. Confirming Recommendations.

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: First Global Approval.

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 ...

A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why.

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...

Assessment of Consistency Between Peer-Reviewed Publications and Clinical Trial Registries.

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.

Twenty-four-month clinical performance of different universal adhesives in etch-and-rinse, selective etching and self-etch application modes in NCCL - a randomized controlled clinical trial.

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).

Effects of topical application of 1% sodium alendronate gel in the surgical treatment of periodontal intrabony defects: a 6-month randomized controlled clinical trial.

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.

OCTANE: Oncology Clinical Trial Annotation Engine.

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.

Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy.

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...

Are we capable of separating the wheat from the chaff when assessing meta-analyses?

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.

Prototype of running clinical trials in an untrustworthy environment using blockchain.

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...

High flavonoid cocoa supplement ameliorates plasma oxidative stress and inflammation levels while improving mobility and quality of life in older subjects: a double blind randomized clinical trial.

The age-related decline in mass, strength and performance of skeletal muscle is associated with loss of independence, falls risk, disability, institutionalization and death.

Systematic Review and Meta-Analysis of the Magnitude of Structural, Clinical, and Physician and Patient Barriers to Cancer Clinical Trial Participation.

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.

Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.

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.

A Long-term Evaluation of Experimental Potassium Oxalate Concentrations on Dentin Hypersensitivity Reduction: A Triple-Blind Randomized Clinical Trial.

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.

Group-sequential logrank methods for trial designs using bivariate non-competing event-time outcomes.

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 ...

Emulating a Novel Clinical Trial Using Existing Observational Data: Predicting Results of the PreVent Study.

"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).

Testosterone for Androgen Deficiency-Like Symptoms in Men Without Pathologic Hypogonadism: A Randomized, Placebo-Controlled Cross-Over with Masked Choice Extension Clinical Trial.

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.


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