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Health plan administrative claims data present a cost-effective complement to traditional trial-specific ascertainment of clinical events typically conducted through patient report or a single health system electronic health record. We aim to demonstrate the value of health plan claims data in improving the capture of endpoints in longitudinal pragmatic clinical trials.
This article was published in the following journal.
Name: Clinical trials (London, England)
Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.
Randomized controlled trials are the "gold standard" for comparing the safety and efficacy of therapies but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world"...
Pediatric stroke investigators identified as their top research priority a clinical trial of corticosteroids for focal cerebral arteriopathy (FCA). However, FCA is both rare and an acute condition mak...
ScreenR2GDM is a pragmatic randomized clinical trial designed to investigate if one of two gestational diabetes (GDM) screening and treatment protocols results in improved outcomes in the context of s...
To develop and validate a measure that estimates individual level poverty in Medicare administrative data that can be used in studies of Medicare claims.
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 framewo...
The objectives of this study are, first, to identify select clinical covariates from electronic medical records (EMR) that might be associated with initiation of oral anticoagulant medicat...
The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with serious illness and their caregivers within the Mount Sinai Health System....
Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular ...
Pragmatic study comparing historical data from usual collection tools to medical administrative databases (local / national PMSI and CRF / SNIIRAM). There are 3 phases to the data collecti...
The Shared Health CHR™ (Clinical Health Record) offers point-of-care clinical reporting and decision support based primarily on patient claims data aggregated across various health care...
Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts.
Clinical study in which a prospectively planned opportunity is included to modify trial designs and hypotheses based on analysis of data from subjects in the study.
Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.
Works about clinical studies in which a prospectively planned opportunity is included to modify trial designs and hypotheses based on analysis of data from subjects in the study .
Work that is a report of a planned post-marketing study of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale after clinical trials, phases I, II, and III. These studies, conducted in the United States or a foreign country, often garner additional data about the safety and efficacy of a product.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...