Results 151 to 160 of about 55,432,686 (234)

Editorial: Advances in biomarkers and drug targets: harnessing traditional and AI approaches for novel therapeutic mechanisms. [PDF]

Front Pharmacol
Chen S.
europepmc   +1 more source

Time‐Dependent Bias and Prognostic Confounding in Exposure–Response Analysis of Targeted Therapies: Lessons from Sunitinib in Metastatic Renal Cancer

Clinical Pharmacology &Therapeutics, EarlyView.
Exposure–response (E–R) analyses of sunitinib in metastatic renal cell carcinoma (mRCC) have supported concentration‐guided dose escalation. However, such analyses may be biased when exposure metrics incorporate post‐baseline dose modifications, time‐varying apparent clearance, or baseline factors that influence both pharmacokinetics and clinical ...
Han Liu, Lena E. Friberg
wiley   +1 more source

EGPRN primary care research at a crossroads advancing research on interprofessional collaboration and on integrated, equitable and complex care. An EGPRN Keynote Paper from the Autumn 2025 Plovdiv Conference. [PDF]

Eur J Gen Pract
Van Royen P.
europepmc   +1 more source

Initiation of Gabapentin with Opioids and Risk of Respiratory Cardiovascular and Opioid‐Related Adverse Events Following Surgery for Breast Cancer

Clinical Pharmacology &Therapeutics, EarlyView.
Pain is a key determinant of quality‐of‐life following breast cancer surgery, the most common cancer operation in the United States. Gabapentinoids are frequently prescribed for pain management, yet their respiratory, cardiovascular, and opioid‐related adverse effects remain unclear.
Jyun‐Heng Lai, Anton L V Avanceña, Juan P Cata, Jamie C. Barner, Sharon H. Giordano, Chanhyun Park, Hui Zhao, Kirk E. Evoy, John K. Lin, Jennifer C. Spencer, Mariana Chavez‐MacGregor, Kelly K. Hunt, Kerollos Nashat Wanis   +12 more
wiley   +1 more source

Implementing an exercise intervention for sarcopenia in oldest-old nursing home residents: protocol for a pragmatic cluster-randomized controlled trial (SCOPE Study). [PDF]

BMC Geriatr
Xiang C, Li L, Zhao J, Zhou Y, Cai W, Guo Y, Yang Z, An X, Gu C, Ding R, Wu X, Wang Y, Wang D, Xu S, Liu Z, Gao Y.   +15 more
europepmc   +1 more source

Enhancing Evidence Generation by Linking Randomized Clinical Trials to Real‐World Data: The INVESTED‐Medicare Linkage Study

Clinical Pharmacology &Therapeutics, EarlyView.
Real‐world evidence (RWE) derived from real‐world data (RWD) can complement randomized controlled trials (RCTs), yet the validity of RWD relative to RCT data remains insufficiently characterized. We obtained post hoc consent and linked individual participant data from the US‐based INVESTED trial (2016–2019) with Medicare fee‐for‐service claims (2012 ...
Hanseul Cho, HoJin Shin, Mehdi Najafzadeh, Brian Claggett, Janinne Ortega‐Montiel, Jun Liu, Julie M. Paik, Narlina F. Lalani, Marie C. Bradley, John Concato, Scott D. Solomon, Orly Vardeny, Elisabetta Patorno   +12 more
wiley   +1 more source

The Scandinavian Displaced Lateral Clavicle trial (ScanDiLaC): a study protocol for a randomized clinical trial. [PDF]

Trials
Christersson P, Karimi D, Grønhaug K, Launonen A, Brorson S, Frihagen F, Viberg B, Hailer N, Wolf O.   +8 more
europepmc   +1 more source

From Biological Mechanisms to Causal Inference: Quantitative Systems Pharmacology and Causal Frameworks in Drug Development

Clinical Pharmacology &Therapeutics, EarlyView.
Digital patients and in silico clinical trials offer new opportunities to advance pharmacological research, clinical development, and regulatory decision‐making by enabling the simulation of treatment effects prior to testing in patients. Among the most promising of these opportunities is the combined use of quantitative systems pharmacology (QSP) and ...
Thomas Klabunde, Ramon Hernandez, Piet H. van der Graaf, Tommaso Andreani   +3 more
wiley   +1 more source

Timing to restart direct oral anticoagulants after traumatic intracranial haemorrhage (RESTART tICrH): study protocol for a randomised controlled multicentre trial. [PDF]

BMJ Open
Edlmann E, Kannan S, Wright L, Hardwick B, Brown M, Gornall M, McLoughlin T, Haunton V, Pijeira Perez Y, Hughes DA, Vine N, Grantham H, Milling TJ, Lane DA, Lip GYH, Jenkinson MD, McMahon CJ.   +16 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