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Analysis of a Proof of Concept Study
2017From the data analysis perspective, clinical statisticians are typically faced with continuous data, discrete data, or time-to-event data. For early Phase II clinical trials, the most frequently seen data types are continuous data or binary data. In this chapter, and the next two chapters covering data analysis, the discussion will mainly be about ...
Naitee Ting +3 more
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Modelling STEMI service delivery: a proof of concept study
Emergency Medicine Journal, 2021BackgroundAccess to individual percutaneous coronary intervention (PCI) centres has traditionally been determined by historical referral patterns along arbitrarily defined geographic boundaries. We set out to produce predictive models of ST-elevation myocardial infarction (STEMI) demand and time-efficient access to PCI centres.MethodsTravel times from ...
Justin Cole +7 more
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Abstract Objectives and principles for proof of concept studies are emphasized, and the utility of Bayesian statistics and Lalonde criteria is highlighted.
Phil Ambery +2 more
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Phil Ambery +2 more
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Toward gesture controlled wheelchair: A proof of concept study
2013 IEEE 13th International Conference on Rehabilitation Robotics (ICORR), 2013This study focuses on the early stages of developing and testing an interactive approach for gesture-based wheelchair control that could facilitate the user in various tasks such as cooking and food serving. The proposed method allows a user to hold an object (tray, saucepan, etc) with both hands and to control at the same time the wheelchair direction
Noriyuki Kawarazaki +2 more
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The Paperless Labeling Initiative: A Proof-of-Concept Study
Annals of Pharmacotherapy, 2004BACKGROUND: Traditional paper professional package inserts (PPIs) are used on a daily basis by a variety of healthcare providers to locate and disseminate drug information. Unfortunately, paper PPIs are sometimes not accessible to the healthcare provider, appear unreadable due to varied font sizes, and are often considered not to be user-friendly.
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SAMPLE SIZE CALCULATION FOR A PROOF OF CONCEPT STUDY
Journal of Biopharmaceutical Statistics, 2002Sample size calculation is vital for a confirmatory clinical trial since the regulatory agencies require the probability of making Type I error to be significantly small, usually less than 0.05 or 0.025. However, the importance of the sample size calculation for studies conducted by a pharmaceutical company for internal decision making, e.g., a proof ...
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Study bystanders and ethical treatment of study participants—A proof of concept
Bioethics, 2020ABSTRACTThe ethics of research on human subjects is often construed as a fine balance between the interests of patients in need of novel health interventions, and those of study participants who should remain safe in the process. But there is a third group in the mix.
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The antimicrobial treatment of subacute endometritis: A proof of concept study
American Journal of Obstetrics and Gynecology, 2004Our purpose was to evaluate the antimicrobial therapy effect on clinical and laboratory findings among women at risk for endometritis.A prospective antimicrobial treatment trial of 153 women was performed to characterize subacute endometritis and to determine the treatment effect on endometritis resolution.After antimicrobial treatment, significant ...
L O, Eckert +4 more
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Statistical Considerations in Proof-of-Concept Studies
2019The proof-of-concept study is typically the earliest study investigating whether the compound has any efficacy in a patient population. A proof-of-concept study is defined as small-scale trial in well-defined diseases or targeted patient populations, which allows testing of a preclinical hypothesis about a mechanism of action and a quick demonstration ...
Laurence Colin, Brian Smith
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Raman Spectroscopy for Inverted Papilloma: A Proof‐of‐Concept Study
Otolaryngology–Head and Neck Surgery, 2018Inverted papillomas are tumors of the sinonasal tract with a propensity to recur. Raman spectroscopy can potentially identify inverted papillomas from other tissue based on biochemical signatures. A pilot study comparing Raman spectroscopy to histopathology for 3 types of sinonasal tissue was performed.
Marco A, Mascarella +6 more
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