منابع مشابه
Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial
BACKGROUND The UK Clinical Trial Regulations and Good Clinical Practice guidelines specify that the study sponsor must ensure clinical trial data are accurately reported, recorded and verified to ensure patient safety and scientific integrity. The methods that are utilised to assess data quality and the results of any reviews undertaken are rarely reported in the literature. We have recently un...
متن کاملUpdating clinical endpoint definitions
The 6-Minute Walk Distance (6-MWD) has been the most utilized endpoint for judging the efficacy of pulmonary arterial hypertension (PAH) therapy in clinical trials conducted over the past two decades. Despite its simplicity, widespread use in recent trials and overall prognostic value, the 6-MWD has often been criticized over the past several years and pleas from several PAH experts have emerge...
متن کاملExperience from creating electronic systems with generic endpoint review and adjudication flows
Background An increasing number of Clinical Trial Web Portals now include systems to manage endpoint adjudication. These cover the entire process from the initial identification of potential endpoints, the creation of electronic endpoint packages, and assignment of endpoints to members of the relevant Clinical Endpoint Committee (CEC) to the final adjudication verdict being entered into the sys...
متن کاملUtilitarian Adjudication
In this paper I offer a defense of the view that judges should decide cases in accordance with act utilitarianism: i.e., in whatever way maximizes overall well-being. To advance this thesis, I first briefly give reasons for dissatisfaction with the commonsense thought that judges should just decide cases as the law requires. I then briefly argue for the claim that all moral agents, including ju...
متن کاملEffects of the Endpoint Adjudication Process on the Results of a Randomised Controlled Trial: The ADVANCE Trial
BACKGROUND Endpoint adjudication committees (EPAC) are widely used in clinical trials. The aim of the present analysis is to assess the effects of the endpoint adjudication process on the main findings of the ADVANCE trial (Trial registration: ClinicalTrials.gov NCT00145925). METHODS AND FINDINGS The ADVANCE trial was a multicentre, 2 × 2 factorial randomised controlled trial of blood pressur...
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ژورنال
عنوان ژورنال: The Lancet
سال: 2020
ISSN: 0140-6736
DOI: 10.1016/s0140-6736(20)30635-8