Results 261 to 270 of about 2,535,602 (380)

Investigational Use of Real‐World Data as a Hybrid Control in Pancreatic Ductal Adenocarcinoma From the Randomized Phase Ib/II MORPHEUS Trial

Clinical Pharmacology &Therapeutics, Volume 117, Issue 4, Page 1021-1029, April 2025.
Enrolling adequate numbers of patients into the control arm of randomized controlled trials (RCTs) often presents barriers. There is interest in leveraging real‐world data (RWD) from electronic health records (EHRs) to construct external control (EC) arms to supplement RCT control arms and form hybrid control (HC) arms.
Andrew H. Ko, Do‐Youn Oh, Janet Lau, Shivani K. Mhatre, Bo Ci, Robson Machado, Shi Li, Michael T. Bretscher, Irmarie Reyes‐Rivera, Jiawen Zhu, Xiaosong Zhang, Jilpa Patel, Matthew A. Psioda, Mariano Ponz‐Sarvise   +13 more
wiley   +1 more source

Statistical primer: an introduction into the principles of Bayesian statistical analyses in clinical trials. [PDF]

Eur J Cardiothorac Surg
Heuts S, Kawczynski MJ, Velders BJJ, Brophy JM, Hickey GL, Kowalewski M.   +5 more
europepmc   +1 more source

Decision‐Making Criteria and Methods for Initiating Late‐Stage Clinical Trials in Drug Development From a Multi‐Stakeholder Perspective: A Scoping Review

Clinical Pharmacology &Therapeutics, Volume 117, Issue 4, Page 978-988, April 2025.
The decision‐making process in drug development involves “go/no‐go” decisions, particularly at the transition from early to late‐stage trials. While the decisions are solely made by drug developers, they must take into account the perspectives of multiple stakeholders—such as regulatory agencies, HTA bodies, payers, patients, and ethics committees—to ...
Ce Jiang, Céline Beji, Sonia Zebachi, Ghinwa Y. Hayek, Aysun Cetinyurek‐Yavuz, Muhammad Bergas N. Fayyad, Laura Rodwell, Kit C. B. Roes, Billy Amzal, Christoph Gerlinger, Raphaël Porcher, Julien Tanniou   +11 more
wiley   +1 more source

A bayesian approach to inclusion based rock physics modeling with multiple statistical ensembles. [PDF]

Sci Rep
Spikes KT, Sen MK.
europepmc   +1 more source

Bayesian Estimates of Transition Probabilities in Seven Small Lithophytic Orchid Populations: Maximizing Data Availability from Many Small Samples

, 2014
Raymond L. Tremblay, Michael A. McCarthy
openalex   +2 more sources

On the Concepts, Methods, and Use of “Probability of Success” for Drug Development Decision‐Making: A Scoping Review

Clinical Pharmacology &Therapeutics, Volume 117, Issue 4, Page 967-977, April 2025.
Drug development is a lengthy process with considerable uncertainty at each milestone. Several trials are needed to progress to confirmatory evaluation and establish a positive benefit–risk balance. One of the critical milestones is the decision to progress to phase III based on phase II trial results. Use of probability of success is becoming standard
Aysun Cetinyurek Yavuz, Muhammad Bergas Nur Fayyad, Ce Jiang, Florie Brion Bouvier, Celine Beji, Sonia Zebachi, Ghinwa Y. Hayek, Billy Amzal, Raphael Porcher, Julien Tanniou, Kit Roes, Laura Rodwell   +11 more
wiley   +1 more source

Ticagrelor Compared to Clopidogrel in Acute Coronary Syndromes trial (TC4): a Bayesian pragmatic cluster randomized controlled trial. [PDF]

CMAJ
Kutcher SA, Dendukuri N, Dandona S, Nadeau L, Brophy JM.   +4 more
europepmc   +1 more source

Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase

Clinical Pharmacology &Therapeutics, EarlyView.
Apixaban could be a potential treatment option for the prevention of venous thromboembolism (VTE) in children with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL). This analysis describes an updated two‐compartment population pharmacokinetic (PPK) model that characterizes the PK variability of apixaban in pediatric patients with ALL ...
Praneeth Jarugula, Toni Ajavon‐Hartmann, Obinna Obianom, Elizabeth Ludwig, Christina Crevar, David Marchisin, Zhaoqing Wang, Weidong Chen, Bing He, Lesley G. Mitchell, Vilmarie Rodriguez, Glen Lew, Vidya Perera, Bindu Murthy, Samira Merali   +14 more
wiley   +1 more source

Distribution-free Bayesian analyses with the DFBA statistical package. [PDF]

Behav Res Methods
Chechile RA, Barch DH.
europepmc   +1 more source