Search Results - "CLINICAL trials monitoring"

Joint modeling of longitudinal endpoints and its applications to trial planning, monitoring and analysis.

Authors: Zhang, Liangcai Capuano, George Dragalin, Vladimir et al.

Source: Journal of Biopharmaceutical Statistics. Oct2025, Vol. 35 Issue 6, p1161-1175. 15p.

Subject Terms: *CLINICAL trials monitoring, CLINICAL trials, TREATMENT effectiveness, MULTISCALE modeling, EXPERIMENTAL design, STATISTICAL learning, REPEATED measures design, STATISTICAL software

A crucial role of on-site clinical trial monitoring: Insights from the ethics committee.

Authors: Chindhalore, Chaitali Ashish Dakhale, Ganesh Natthuji Gajbhiye, Snehalata

Source: Perspectives in Clinical Research. Jul-Sep2025, Vol. 16 Issue 3, p132-137. 6p.

Subject Terms: *CLINICAL trials monitoring, *REGULATORY compliance, *PER diem allowances, *DATA integrity, *ETHICS committees

Medial temporal lobe atrophy in Down syndrome along the Alzheimer's disease continuum.

Authors: Buehner, Benjamin J Morcillo-Nieto, Alejandra O Zsadanyi, Sara E et al.

Source: Brain: A Journal of Neurology. Jul2025, Vol. 148 Issue 7, p2509-2521. 13p.

Subject Terms: *ALZHEIMER'S disease, *CLINICAL trials monitoring, *SYMPTOMS, *PATHOLOGY, *TEMPORAL lobe

Improving the usability of grading scales for drug-induced ototoxicity with a focus on real world data collection.

Authors: Koot, Melissa Crul, Mirjam van Balen, Dorieke et al.

Source: European Archives of Oto-Rhino-Laryngology. Jun2025, Vol. 282 Issue 6, p3343-3347. 5p.

Subject Terms: *CLINICAL trials monitoring, *PATIENT reported outcome measures, *CANCER patient care, *MEDICAL sciences, *HEARING disorders

Futility Monitoring in Clinical Trials.

Authors: Ortega‐Villa, Ana M. Grieco, Megan C. Rubenstein, Kevin et al.

Source: Statistics in Medicine. Jun2025, Vol. 44 Issue 13/14, p1-12. 12p.

Subject Terms: *CLINICAL trials, *CLINICAL trials monitoring, *STATISTICAL significance, *BETA functions, *FRUSTRATION

Predictive Probabilities Made Simple: A Fast and Accurate Method for Clinical Trial Decision‐Making.

Authors: Marion, Joe Lorenzi, Elizabeth Allen‐Savietta, Cora et al.

Source: Statistics in Medicine. Jun2025, Vol. 44 Issue 13/14, p1-10. 10p.

Subject Terms: *CLINICAL trials monitoring, *PROBABILITY theory, *CLINICAL trials, *FRUSTRATION

The Whys, Whens, and Hows of Futility Monitoring.

Authors: Higgins, Karen M. Zalkikar, Jyoti Zhang, Jialu et al.

Source: Statistics in Medicine. May2025, Vol. 44 Issue 10-12, p1-5. 5p.

Subject Terms: *CLINICAL trials monitoring, *TIME trials, *FRUSTRATION, *MORAL reasoning, *PUBLIC health

Sequential monitoring clinical trial by conditional power under drift fractional Brownian motion.

Authors: Xia, Leixin Chen, Baojiang Lai, Dejian

Source: Communications in Statistics: Simulation & Computation. 2024, Vol. 53 Issue 10, p4676-4684. 9p.

Subject Terms: *CLINICAL trials monitoring, *STOCHASTIC processes, WIENER processes, FRACTIONAL powers, MOTION analysis

Antidopaminergic medications in Huntington's disease.

Authors: Tan, Andrew M Geva, Michal Goldberg, Y Paul et al.

Source: Journal of Huntington's Disease. Feb2025, Vol. 14 Issue 1, p16-29. 14p.

Subject Terms: *HUNTINGTON disease, *CLINICAL trials monitoring, *SYMPTOMS, *COGNITION disorders, *CENTRAL nervous system

Comprehensive assessment reveals numerous clinical and neurophysiological differences between MECP2‐allelic disorders.

Authors: Pehlivan, Davut Huang, Chengjun Harris, Holly K. et al.

Source: Annals of Clinical & Translational Neurology. Feb2025, Vol. 12 Issue 2, p433-447. 15p.

Subject Terms: *CLINICAL trials monitoring, *SLEEP physiology, *CLINICAL trials, *RETT syndrome, *EYE movements

Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift.

Authors: Zhang, Peng Shih, Weichung Joe Lin, Yong et al.

Source: Statistics in Biopharmaceutical Research. Jan-Mar2025, Vol. 17 Issue 1, p102-112. 11p.

Subject Terms: *CLINICAL trials monitoring, *OVERALL survival, *TRIAL practice, *CLINICAL trials, *SAMPLE size (Statistics), *BROWNIAN motion

Advancing Potency Assay Development for Advanced Therapy Medicinal Products: A Comprehensive Approach and Regulatory Insights.

Authors: Abdellatif, Alaa Bou Jaoudeh, Melissa Zwiers, Alex et al.

Source: Human Gene Therapy; Nov2025, Vol. 36 Issue 21/22, p1371-1386, 16p

Subject Terms: BIOLOGICAL assay, STANDARDS, REGENERATIVE medicine, TECHNOLOGICAL innovations, CLINICAL trials monitoring, BIOTECHNOLOGY, TREATMENT effectiveness

Company/Entity: UNITED States. Food & Drug Administration

Hyperkalemia risk of finerenone versus spironolactone in CKD patients with type 2 diabetes.

Authors: Idowu, Abiodun Lo, Kevin Bryan Adebolu, Olayinka et al.

Source: Nephrology Dialysis Transplantation; Oct2025, Vol. 40 Issue 10, p1996-1999, 4p

Subject Terms: TYPE 2 diabetes, CHRONIC kidney failure, CLINICAL trials monitoring, NOSOLOGY, PATIENT compliance

A new trial monitoring plan (TMP) template for clinical trials: output from a Delphi process.

Authors: Taheri, Shiva Yorke-Edwards, Victoria Sydes, Matthew R. et al.

Source: Trials. 11/9/2024, Vol. 25 Issue 1, p1-9. 9p.

Subject Terms: *CLINICAL trials monitoring, *NEW trials, *CLINICAL trials, *QUALITY assurance, *MEDICAL research, *DELPHI method

Bayesian Methods for Quality Tolerance Limit (QTL) Monitoring.

Authors: Poythress, J. C. Lee, Jin Hyung Takeda, Kentaro et al.

Source: Pharmaceutical Statistics. Nov2024, Vol. 23 Issue 6, p1166-1180. 15p.

Subject Terms: *CLINICAL trials monitoring, *STATISTICAL process control, *FALSE alarms, *BEST practices

Comparing GBA1‐Parkinson's disease and idiopathic Parkinson's disease: α‐Synuclein oligomers and synaptic density as biomarkers in the skin biopsy.

Authors: Mazzetti, Samanta Contaldi, Elena Basellini, Milo Jarno et al.

Source: Brain Pathology. Nov2024, Vol. 34 Issue 6, p1-13. 13p.

Subject Terms: *PARKINSON'S disease, *CLINICAL trials monitoring, *NEUROLOGICAL disorders, *AUTONOMIC nervous system, *SKIN biopsy, *SWEAT glands

Assessing disease progression and treatment response in progressive multiple sclerosis.

Authors: Comi, Giancarlo Dalla Costa, Gloria Stankoff, Bruno et al.

Source: Nature Reviews Neurology. Oct2024, Vol. 20 Issue 10, p573-586. 14p.

Subject Terms: *THERAPEUTICS, *CLINICAL trials monitoring, *OPTICAL coherence tomography, *CEREBRAL atrophy, *POSITRON emission tomography

Effect of telemonitoring on readmissions for acute exacerbation of chronic obstructive pulmonary disease: A randomized clinical trial.

Authors: Andersen, Frank D Trolle, Christian Pedersen, Asger Roer et al.

Source: Journal of Telemedicine & Telecare. Oct2024, Vol. 30 Issue 9, p1417-1424. 8p.

Subject Terms: *CHRONIC obstructive pulmonary disease, *CLINICAL trials monitoring, *EXPIRATORY flow, *PROPORTIONAL hazards models, *OXYGEN saturation

Epistemic uncertainty in Bayesian predictive probabilities.

Authors: Liu, Charles C. Yu, Ron Xiaolong

Source: Journal of Biopharmaceutical Statistics. May2024, Vol. 34 Issue 3, p394-412. 19p.

Subject Terms: *CLINICAL trials monitoring, *PROBABILITY theory, *UNCERTAINTY (Information theory), EPISTEMIC uncertainty, OPTIMAL stopping (Mathematical statistics)

The Confidence Trap: When Knowing Just Enough Becomes Dangerous #Errogance.

Authors: MCGOWAN, BRIAN S.¹

Source: Applied Clinical Trials. Oct2025, Vol. 34 Issue 4, p12-13. 2p.

Subject Terms: *CLINICAL trials monitoring, *SELF-confidence, *DIGITAL learning, *MENTAL training, *CERTAINTY, *SELF-evaluation, *PREPAREDNESS