Results 171 to 180 of about 4,832 (251)

Time-Related Considerations for Modeling Event-Based Data Collected via Ecological Momentary Assessment. [PDF]

Adv Methods Pract Psychol Sci
Benson L, Hébert ET, Hartman N, Sperry SH, Dempsey W, Kendzor DE, Businelle MS, Ram N.   +7 more
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

Families being supportive together: A multimethod and multi-informant intensive longitudinal study of family protective mechanisms for adolescent depression. [PDF]

Psychol Assess
Bai S, Froidevaux NM, Chen M, High AC, Ewing KE, DeFelice J, Weaver J, Ngigi KW, Riccio MR, Chiang SC, Bai L, Lunkenheimer ES, Brick TR.   +12 more
europepmc   +1 more source

Navigating the Prescription Drug Information System

Clinical Pharmacology &Therapeutics, EarlyView.
Information on new prescription drugs is increasingly complex and fragmented, posing challenges for healthcare professionals, patients, and payers. Clinicians require concise, actionable guidance to support prescribing decisions, while patients seek to balance benefits and harms when making decisions aligned with their treatment goals.
Irina V. Wang, Courtney Davis, Robin Forrest, Avi Cherla, Maximilian Siebert, Janice Cowden, Sophia Walker, Tamar Krishnamurti, Florence T. Bourgeois, Steven Woloshin, Anita K. Wagner, Huseyin Naci   +11 more
wiley   +1 more source

The Use of Ecological Momentary Assessments to Measure Perceived Stress in People With Aphasia: A Feasibility Study. [PDF]

J Speech Lang Hear Res
Jewell CC, Krok-Schoen JL, Harnish SM.
europepmc   +1 more source

External Control Arms in Japan: A Systematic Case Analysis of Documented Regulatory Implementation and Uncertainty Management

Clinical Pharmacology &Therapeutics, EarlyView.
External control arms (ECAs) have emerged as important tools to provide benchmark evidence on comparator effectiveness and thereby support regulatory decision making in situations where randomized controlled trials are difficult to conduct. However, how key methodological elements for ECAs are documented and implemented in practice and how residual ...
Suguru Okami, Alexandros Sagkriotis
wiley   +1 more source

Daily Negative Affect and Reaction Time Inconsistency in Emerging Adults: Ecological Momentary Assessment Study. [PDF]

JMIR Mhealth Uhealth
Rutter LA, Chen PY, Lakhan P, Germine LT, Hawks Z.   +4 more
europepmc   +1 more source

Operationalizing Precision Medicine in Drug Development: Predictive Biomarkers, Companion Diagnostics, and Regulatory Pathways

Clinical Pharmacology &Therapeutics, EarlyView.
Precision medicine offers the opportunity to improve the benefit–risk profile of new therapies by prospectively identifying patients most likely to respond or least likely to experience harm; however, its systematic integration into drug development remains inconsistent outside oncology.
Ingrid Holst‐Laubjerg, José M.A. Moreira   +1 more
wiley   +1 more source

GamblingLess: In-The-Moment: a mixed-methods acceptability and engagement evaluation of a gambling just-in-time adaptive intervention. [PDF]

Addict Sci Clin Pract
Dowling NA, Merkouris SS, Greenwood CJ, Youssef GJ, Thomas AC, Hawker CO, Lubman DI, Rodda SN.   +7 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