Results 191 to 200 of about 34,916 (281)

The structure of classes in Uruguay, 1963-1996: a structural-historical perspective. [PDF]

Front Sociol
Boado M, Vanoli S, Rey R.
europepmc   +1 more source

Regulatory Research Priorities for AI Use in the Medicine Lifecycle: A European Perspective with Global Relevance

Clinical Pharmacology &Therapeutics, EarlyView.
Regulatory bodies play a central role in providing guidance that enables safe and effective use of artificial intelligence tools in medicine development and evaluation. Regulators can also act as catalysts for regulatory science research. To inform these efforts, a European‐wide survey was conducted to solicit stakeholder perspectives on the priority ...
Luis C. Pinheiro, Amanda C. Langston, Marie Orre, Joerg Zinserling, Konstantina Boumaki, Bastian V. H. Hornung, Siobhan O'Sullivan, Gabriel Westman, Karl Broich, Peter Arlett   +9 more
wiley   +1 more source

Implementation of a pragmatic pathway to ensure high-quality processing of heterogeneous remote health sensing data. [PDF]

Smart Health (Amst)
Ostovari M, Crimp N, Ashe W, Homdee N, Lach J, Marcelin F, Ogunjirin E, Ratcliffe S, LeBaron V.   +8 more
europepmc   +1 more source

Risk of Bias Associated with Varying Sampling Strategies for External Comparator Cohorts for Single‐Arm Trials: Insights from Aggressive Lymphoma

Clinical Pharmacology &Therapeutics, EarlyView.
Marketing authorizations for oncology drugs are often based on single‐arm trials (SATs), and real‐world data‐based external comparator cohorts (ECCs) are increasingly explored to contextualize results. In retrospective studies, comparators may be identified by time of diagnosis but included based on time of relapse; such sampling strategies can ...
Mikkel Runason Simonsen, Shiva Leisner, Ahmed Ludvigsen Al‐Mashhadi, Laurids Østergaard Poulsen, Matthew Maurer, Lasse Hjort Jakobsen, Tarec Christoffer El‐Galaly   +6 more
wiley   +1 more source

Forecasting alcohol lapse risk up to two weeks in advance using time-lagged machine learning models. [PDF]

PLoS One
Wyant K, Fronk GE, Yu J, Punturieri CE, Curtin JJ.   +4 more
europepmc   +1 more source

Model‐Informed Approaches for Pediatric Type 2 Diabetes Evidence Generation: Insights from a Model‐Based Longitudinal HbA1c Meta‐Analysis from EMA Marketing Authorization Applications

Clinical Pharmacology &Therapeutics, EarlyView.
Evidence generation for antihyperglycemic therapies in pediatric type 2 diabetes mellitus (T2DM) remains challenging, with most randomized trials failing to demonstrate statistically significant reductions in glycated hemoglobin (HbA1c), partly due to substantial between‐subject variability.
Pieter J. Colin, Efthymios Manolis, Jeroen V. Koomen   +2 more
wiley   +1 more source

Validation of a Low-Burden, Once-Daily Obsessive-Compulsive Disorder Measure Over 70 Days: Ecological Momentary Assessment Study. [PDF]

JMIR Form Res
Jiang A, Li R, Fan J, Frank AC.
europepmc   +1 more source

Toward Fit‐for‐Purpose Data for Drug Assessment in Non‐small Cell Lung Cancer: A Core Dataset

Clinical Pharmacology &Therapeutics, EarlyView.
Considering the high unmet medical need in people with non‐small cell lung cancer (NSCLC), the drug assessment for targeted therapies often rely on small populations and single‐arm trials, challenging the evaluation by regulatory authorities, health technology assessment bodies (HTAb), and clinicians.
Geeske F. Grit, Maaike van Dartel, Laura Rodwell, Hanneke van der Woude, Cornelis Boersma, Peter G. M. Mol, Doranne Hilarius   +6 more
wiley   +1 more source

Computer-assisted cognitive remediation (CACR) as a recovery-oriented intervention for schizophrenia: a randomized controlled trial. [PDF]

BMC Psychiatry
Fathi Azar E, Oftadeh Balani S, Motevalli S, Mirzaie H, Haghgoo HA.   +4 more
europepmc   +1 more source

Special Populations in Pivotal Clinical Trials: Eligibility and Supporting Evidence for Exclusion in EMA‐Authorised Medicines

Clinical Pharmacology &Therapeutics, EarlyView.
Evidence on the efficacy and safety of medicines supporting marketing authorization is largely derived from randomized controlled trials, yet these trials often exclude populations likely to use the medications in clinical practice. This study assessed eligibility of special populations, defined as pregnant and breast‐feeding individuals, elderly ...
Maja J. Jørgensen, Débora D. Gräf, Christine E. Hallgreen   +2 more
wiley   +1 more source