Results 201 to 210 of about 34,916 (281)

Menopausal Hormone Therapy in Clinically Vulnerable Women: A Narrative Review of Guidelines and Real-World Evidence. [PDF]

Medicina (Kaunas)
Yanachkova V, Lebanova H, Stoev S.
europepmc   +1 more source

The Governance Gap: Democratizing Drug Development Through Decision Architecture

Clinical Pharmacology &Therapeutics, EarlyView.
Drug development is most exposed to governance failure where it can least afford it, in global health. The field has more predictive power than at any point in its history and roughly the same failure rate it had a decade ago. We argue that this paradox persists because the field has invested heavily in prediction science while neglecting decision ...
Craig R. Rayner, Nancy E. Martin, Danielle Smith, Eliza Kruger, Carl M.J. Kirkpatrick, Goonaseelan (Colin) Pillai, Katy Moore, Darrell Nix, Cristina Donini, Jakob P. Cramer, Edmundo Muniz, Natalia Muniz, Ernst Bos, Douglas McNair, Shyam Bhaskaran, Mark Sullivan, Dan Hartman   +16 more
wiley   +1 more source

Predicting Momentary Suicidal Ideation From Smartphone Screenshots Using Vision-Language Models: Prospective Machine Learning Study. [PDF]

JMIR Ment Health
Jacobucci R, Shao W, Kobrinsky V, Ammerman B.   +3 more
europepmc   +1 more source

From Prediction to Decision Making: PBPK and QSP as Regulatory‐Grade NAMs

Clinical Pharmacology &Therapeutics, EarlyView.
New approach methodologies (NAMs) encompass a diverse and rapidly evolving set of experimental and computational tools designed to generate human‐relevant mechanistic data for use in drug development and regulatory decision making. Experimental NAMs provide insights into drug disposition, pharmacological activity, and disease biology that are difficult
Karen Rowland Yeo, Piet H. van der Graaf
wiley   +1 more source

Mindfulness-based ecological momentary intervention for smoking cessation to address cancer-related relapse risk factors: Intervention development and usability findings. [PDF]

Mindfulness (N Y)
Yang MJ, Sutton SK, Cottrell-Daniels C, Ritterband LM, Blackwell R, Maconi ML, Poudel R, Pabbathi S, Simmons VN, Vinci C.   +9 more
europepmc   +1 more source

A Practical Guide to Implementing Real‐World Evidence as Primary Basis for Approval and Label Expansion

Clinical Pharmacology &Therapeutics, EarlyView.
In June 2026, the FDA issued a revised draft guidance describing the circumstances in which one adequate and well‐controlled clinical investigation plus confirmatory evidence may satisfy the statutory substantial evidence standard for establishing efficacy and safety. Confirmatory evidence includes real‐world evidence (RWE).
Tracy J. Mayne, Maurice A. Brookhart, Nancy A. Dreyer   +2 more
wiley   +1 more source

MOVE@NUS digital intervention cohort: protocol of a pilot study to promote healthy movement in university students. [PDF]

J Act Sedentary Sleep Behav
Chen M, Movia M, Chua XH, Tan SYX, Zheng S, Jin K, Topothai T, Padmapriya N, Müller-Riemenschneider F, Edney S.   +9 more
europepmc   +1 more source

In Silico Clinical Trials in Drug Development: Virtual Patients, Applications, and Regulatory Convergence

Clinical Pharmacology &Therapeutics, EarlyView.
Conventional clinical trials remain the benchmark for evaluating therapeutic safety and efficacy, yet they are constrained by escalating costs, withdrawal over the extended follow‐up periods, recruitment difficulties, ethical limits, and a restricted ability to characterize heterogeneous populations.
Maximilian Balmus, Sheng‐Ya Wang, Edward W. G. Ashton, Rosie K. Barrows, Molly Monks, Yuzhang Ge, Arthur Lefebvre, Steven A. Niederer   +7 more
wiley   +1 more source

Measurement properties of patient-reported outcome measures for sexual health in the general population: a systematic review following the COSMIN 2.0 guidelines. [PDF]

Health Qual Life Outcomes
Shang Y, Yuan Q, Shen Y, Xu K, Zhang G, Ju B.   +5 more
europepmc   +1 more source

Toward the Use of Real‐World Data for Regulatory and HTA Decision‐Making: Experiences and Recommendations from Six EU‐Funded Projects

Clinical Pharmacology &Therapeutics, EarlyView.
Real‐world data are increasingly important for regulatory and health technology assessment decision‐making, yet their effective use across Europe remains limited by technical, methodological, regulatory, and societal challenges. Drawing on the experiences of six Horizon Europe projects in the MetReal cluster, this review summarizes common barriers and ...
Martin Russek, Jonas Peltner, Kerstin Pfeifer, Theodoros N. Arvanitis, Dirk De Valck, Sieta T. de Vries, Michel Dumontier, Vera Ehrenstein, Omaima El Hakouni, Gregory Epiphaniou, Gokhan Ertaylan, Joana Fernandes, Scott Hansen, Stuart Harrison, Erzsébet Horváth‐Puhó, Saif Ul Islam, Pekka Kahri, Julia K. Mader, Carsten Maple, Nikolaos Matragkas, Shivani Misra, Peter G.M. Mol, Anne Paakinaho, Sami Pakarinen, Martina Radanović, Evy Reviers, Kathrine Kold Sørensen, Marco Spruit, Christina Tikka, Anna‐Maija Tolppanen, Christian Torp‐Pedersen, Mirna Vela, Thuan Vo, Puriya Daniel Würtz Yazdanfard, Britta Haenisch   +34 more
wiley   +1 more source