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Leveraging hybrid biomarkers in clinical endpoint prediction [PDF]
BMC Medical Informatics and Decision Making, 2020 Background Clinical endpoint prediction remains challenging for health providers. Although predictors such as age, gender, and disease staging are of considerable predictive value, the accuracy often ranges between 60 and 80%.
Maliazurina Saad, Ik Hyun Lee
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Updating clinical endpoint definitions. [PDF]
Pulm Circ, 2013 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
Hassoun PM +11 more
europepmc +4 more sources
When do we need clinical endpoint adjudication in clinical trials? [PDF]
Upsala Journal of Medical Sciences, 2019 Clinical endpoint adjudication (CEA) is a standardized process for assessment of safety and efficacy of pharmacologic or device therapies in clinical trials.
Claes Held
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Multi-omics integration for neuroblastoma clinical endpoint prediction [PDF]
Biology Direct, 2018 Background High-throughput methodologies such as microarrays and next-generation sequencing are routinely used in cancer research, generating complex data at different omics layers.
Margherita Francescatto +5 more
doaj +2 more sources
Clinical endpoints in pragmatic heart failure trials: From data collection to clinical endpoint classification [PDF]
ESC Heart FailureClinical endpoint classification (CEC)—that is, evaluation of clinical events using pre‐defined criteria—is commonly conducted in clinical trial operations to ensure systematic and consistent assessment of endpoints needed to assess the intervention's ...
Veraprapas Kittipibul +13 more
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Suicidal thinking as a valuable clinical endpoint [PDF]
EClinicalMedicine, 2020 Evan M. Kleiman
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Evaluating amyloid-beta as a surrogate endpoint in trials of anti-amyloid-beta drugs in Alzheimer’s disease: a Bayesian meta-analysis [PDF]
Journal of Comparative Effectiveness ResearchAim: The use of amyloid-beta (Aβ) clearance to support regulatory approvals of drugs in Alzheimer’s disease (AD) remains controversial. We evaluate Aβ as a potential trial-level surrogate endpoint for clinical function in AD.
Sa Ren +10 more
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Frontiers in Psychiatry, 2023 The novel mechanisms of action (MOA) derived from some recently introduced molecular targets have led to regulatory approvals for rapid acting antidepressants (RAADs) that can generate responses within hours or days, rather than weeks or months.
Christian Yavorsky +5 more
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Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 2023 Alzheimer's disease (AD) staging criteria lack standardized, empirical description. Well‐defined AD staging criteria are an important consideration in protocol design, influencing a more standardized inclusion/exclusion criteria and defining what ...
Ronald C. Petersen +10 more
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Clinical and Translational Allergy, 2022 Background The European Academy of Allergy and Clinical Immunology recommended the Combined Symptom and Medication Score (CSMS) as primary endpoint in clinical trials on allergen‐specific immunotherapy (AIT) in allergic rhinoconjunctivitis.
Binoy Palathumpattu +9 more
doaj +1 more source