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CERobs Consulting

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Articles

A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials - Therapeutic Innovation & Regulatory Science

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By Patient Outcomes, CERobs Consulting, Wrightsville Beach
| link.springer.com
Abstract Single-arm clinical trials (SAT) are common in drug and biologic submissions for rare or life-threatening conditions, especially when no therapeutic options exist. External control arms (ECAs) improve interpretation of SATs but pose methodological and regulatory challenges.
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Increased risk of incident dementia following use of anticholinergic agents: A systematic literature review and meta‐analysis

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By Roger Dmochowski, Sydney Thai, CERobs Consulting, Kristy Iglay
| Wiley Online Library Verified
Abstract Background/rationale Long-term treatment with anticholinergic agents may increase the risk of cognitive impairment or dementia. This systematic literature review and meta-analysis aimed to assess the impact of ≥3 months of exposure to anticholinergics as a class on the risk of dementia, mild cognitive impairment, and change in cognitive function. The impact of anticholinergic agents specifically used to treat overactive bladder was also evaluated.
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Global epidemiology of factor XI deficiency: A targeted review of the literature and foundation reports

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By Xinruo Zhang, CERobs Consulting, Indiana Hemophilia, Magdalena Lewandowska
| Wiley Online Library Verified
Abstract Introduction Hereditary factor XI (FXI) deficiency is a rare coagulation disorder that may result in excessive bleeding requiring intervention to restore haemostasis. Aim The aim of this review was to report the current knowledge of the worldwide incidence and prevalence of FXI deficiency. Methods A targeted PubMed search using terms related to FXI deficiency was conducted to identify studies published from April 2002 through April 2022. A manual search supplemented the electronic search.
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