Results 221 to 230 of about 3,165,419 (303)

Dynamic survival risk prediction with time‐varying high‐dimensional images

open access: yesCanadian Journal of Statistics, EarlyView.
Abstract Integrating longitudinal data with survival models is a prevalent strategy for dynamic survival risk prediction while accounting for subjects' longitudinally observed variables. However, existing methods primarily focus on scalar longitudinal data and seldom tackle the complexities associated with high‐dimensional longitudinal imaging data ...
Bingfan Liu   +7 more
wiley   +1 more source

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

open access: yesClinical 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   +6 more
wiley   +1 more source

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

open access: yesClinical 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   +6 more
wiley   +1 more source

Considerations for the Integration of Clinical Trials and Real‐World Data

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
As clinical decision‐making increasingly moves toward individualized and context‐specific treatment recommendations, reliance on any single evidence source, randomized or observational, may be insufficient. Principled integration of randomized controlled trials and real‐world data, grounded in explicit causal frameworks, offers a path toward evidence ...
Sky Qiu   +19 more
wiley   +1 more source

Unintended Pregnancies and Breastfeeding Studies during Central Nervous System Drug Development: How Are they Handled, Is There Room for Improvement?

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Pregnant and breastfeeding individuals are routinely excluded from clinical drug development, creating persistent evidence gaps in pharmacology, safety, and dosing. Despite mandatory contraception and pregnancy testing, unintended pregnancies occur, particularly during the development of central nervous system (CNS) medicines used by women of ...
Sam Schoenmakers   +4 more
wiley   +1 more source

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