Suchergebnisse - "Phase II as Topic"

Bayesian Integrated Learning of Longitudinal Dose-Response Relationships via Decentralized Clinical Trials.

Autoren: Zhang J Wang T Qu Y et al.

Quelle: Statistics in medicine [Stat Med] 2025 Dec; Vol. 44 (28-30), pp. e70338.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: England NLM ID: 8215016 Publication Model: Print Cited Medium: Internet ISSN: 1097-0258 (Electronic) Linking ISSN: 02776715 NLM ISO Abbreviation: Stat Med Subsets: MEDLINE

MeSH-Schlagworte: Dose-Response Relationship, Drug* , Clinical Trials, Phase II as Topic*/methods , Clinical Trials, Phase II as Topic*/statistics & numerical data, Bayes Theorem ; Humans ; Longitudinal Studies ; Computer Simulation ; Models, Statistical ; Bias

Great Wall: A Generalized Dose Optimization Design for Drug Combination Trials Maximizing Survival Benefit.

Autoren: Han Y Qiu Y Zhao Y et al.

Quelle: Pharmaceutical statistics [Pharm Stat] 2025 Nov-Dec; Vol. 24 (6), pp. e70049.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print Cited Medium: Internet ISSN: 1539-1612 (Electronic) Linking ISSN: 15391604 NLM ISO Abbreviation: Pharm Stat Subsets: MEDLINE

MeSH-Schlagworte: Research Design* , Clinical Trials, Phase I as Topic*/methods , Clinical Trials, Phase I as Topic*/statistics & numerical data , Clinical Trials, Phase II as Topic*/methods , Clinical Trials, Phase II as Topic*/statistics & numerical data, Humans ; Dose-Response Relationship, Drug ; Algorithms ; Computer Simulation ; Drug Combinations ; Randomized Controlled Trials as Topic/methods ; Drug Therapy, Combination

Adjustment for Inconsistency in Adaptive Phase 2/3 Designs With Dose Optimization.

Autoren: Chen C Huang M Zhang X

Quelle: Pharmaceutical statistics [Pharm Stat] 2025 Nov-Dec; Vol. 24 (6), pp. e70031.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print Cited Medium: Internet ISSN: 1539-1612 (Electronic) Linking ISSN: 15391604 NLM ISO Abbreviation: Pharm Stat Subsets: MEDLINE

MeSH-Schlagworte: Research Design*/statistics & numerical data , Clinical Trials, Phase II as Topic*/methods , Clinical Trials, Phase II as Topic*/statistics & numerical data , Clinical Trials, Phase III as Topic*/methods , Clinical Trials, Phase III as Topic*/statistics & numerical data , Antineoplastic Agents*/administration & dosage, Humans ; Dose-Response Relationship, Drug ; Drug Development/methods ; Drug Development/statistics & numerical data ; Data Interpretation, Statistical ; Models, Statistical

BOIN-MEM: A Two-Stage Design for Dose Optimization With Information Borrowing Across Dose Levels and Stages in Oncology Phase I/II Trials.

Autoren: Kitabayashi R Takeda K Sato H et al.

Quelle: Pharmaceutical statistics [Pharm Stat] 2025 Nov-Dec; Vol. 24 (6), pp. e70045.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print Cited Medium: Internet ISSN: 1539-1612 (Electronic) Linking ISSN: 15391604 NLM ISO Abbreviation: Pharm Stat Subsets: MEDLINE

MeSH-Schlagworte: Clinical Trials, Phase I as Topic*/methods , Clinical Trials, Phase I as Topic*/statistics & numerical data , Research Design*/statistics & numerical data , Clinical Trials, Phase II as Topic*/methods , Clinical Trials, Phase II as Topic*/statistics & numerical data , Antineoplastic Agents*/administration & dosage , Antineoplastic Agents*/adverse effects , Neoplasms*/drug therapy, Humans ; Dose-Response Relationship, Drug ; Bayes Theorem ; Maximum Tolerated Dose ; Models, Statistical ; Computer Simulation

Biomarker-guided adaptive enrichment design with threshold detection for clinical trials with time-to-event outcome.

Autoren: Hua K Hong H Wang X

Quelle: Journal of biopharmaceutical statistics [J Biopharm Stat] 2025 Oct; Vol. 35 (6), pp. 1209-1226. Date of Electronic Publication: 2025 Apr 20.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Taylor & Francis Country of Publication: England NLM ID: 9200436 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-5711 (Electronic) Linking ISSN: 10543406 NLM ISO Abbreviation: J Biopharm Stat Subsets: MEDLINE

MeSH-Schlagworte: Research Design*/statistics & numerical data , Biomarkers*/analysis , Randomized Controlled Trials as Topic*/statistics & numerical data , Randomized Controlled Trials as Topic*/methods , Clinical Trials, Phase II as Topic*/statistics & numerical data , Clinical Trials, Phase II as Topic*/methods, Humans ; Treatment Outcome ; Computer Simulation ; Endpoint Determination/statistics & numerical data ; Precision Medicine/statistics & numerical data ; Precision Medicine/methods ; Time Factors ; Adaptive Clinical Trials as Topic/statistics & numerical data ; Survival Analysis

Integrating a pilot study and large trial into one adaptive design.

Autoren: Dai J Gajewski BJ Shergina E et al.

Quelle: Contemporary clinical trials [Contemp Clin Trials] 2025 Dec; Vol. 159, pp. 108112. Date of Electronic Publication: 2025 Oct 22.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Elsevier Country of Publication: United States NLM ID: 101242342 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1559-2030 (Electronic) Linking ISSN: 15517144 NLM ISO Abbreviation: Contemp Clin Trials Subsets: MEDLINE

MeSH-Schlagworte: Research Design* , Clinical Trials, Phase II as Topic*/methods , Randomized Controlled Trials as Topic*/methods , Clinical Trials, Phase III as Topic*/methods , Adaptive Clinical Trials as Topic*/methods, Humans ; Pilot Projects ; Sample Size ; Child ; United States ; Computer Simulation ; National Institutes of Health (U.S.)

Incorporating data from multiple ongoing trials for Bayesian two-stage phase II single-arm studies.

Autoren: Halabi S Choi T Garrett-Mayer E et al.

Quelle: Clinical trials (London, England) [Clin Trials] 2025 Dec; Vol. 22 (6), pp. 667-675. Date of Electronic Publication: 2025 Aug 21.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: SAGE Publications Country of Publication: England NLM ID: 101197451 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1740-7753 (Electronic) Linking ISSN: 17407745 NLM ISO Abbreviation: Clin Trials Subsets: MEDLINE

MeSH-Schlagworte: Clinical Trials, Phase II as Topic*/methods , Research Design* , Neoplasms*/genetics , Neoplasms*/therapy , Neoplasms*/drug therapy, Bayes Theorem ; Humans ; Computer Simulation ; Precision Medicine/methods

Participant motivators and perceptions of risks and benefits in adult Phase 2/3 COVID-19 vaccine clinical trials.

Autoren: Wunderlich B Feijoo B Limaye R et al.

Quelle: Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2025 Dec; Vol. 21 (1), pp. 2521192. Date of Electronic Publication: 2025 Jun 23.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 101572652 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2164-554X (Electronic) Linking ISSN: 21645515 NLM ISO Abbreviation: Hum Vaccin Immunother Subsets: MEDLINE

MeSH-Schlagworte: COVID-19 Vaccines*/administration & dosage , COVID-19*/prevention & control , Clinical Trials, Phase III as Topic*/psychology , Motivation* , Clinical Trials, Phase II as Topic*/psychology, Humans ; Female ; Male ; Middle Aged ; Adult ; Cross-Sectional Studies ; Aged ; Surveys and Questionnaires ; SARS-CoV-2/immunology ; Young Adult

Global Disparities in Current Clinical Trials in Nasopharyngeal Carcinoma.

Autoren: Jainar CJE Jacomina LE Dee EC et al.

Quelle: International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2025 Nov 15; Vol. 123 (4), pp. 1041-1049. Date of Electronic Publication: 2025 Jul 03.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Elsevier, Inc Country of Publication: United States NLM ID: 7603616 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-355X (Electronic) Linking ISSN: 03603016 NLM ISO Abbreviation: Int J Radiat Oncol Biol Phys Subsets: MEDLINE

MeSH-Schlagworte: Nasopharyngeal Carcinoma*/therapy , Nasopharyngeal Carcinoma*/epidemiology , Nasopharyngeal Neoplasms*/therapy , Nasopharyngeal Neoplasms*/epidemiology , Nasopharyngeal Neoplasms*/radiotherapy , Clinical Trials as Topic*/statistics & numerical data , Clinical Trials, Phase II as Topic*/statistics & numerical data , Clinical Trials, Phase III as Topic*/statistics & numerical data , Healthcare Disparities*/statistics & numerical data , Global Health*/statistics & numerical data, Humans ; Incidence ; Adult

Association of Statistical Methodology and Design in Preclinical Animal Studies With Successful Translation Into Clinical Phase 2 Trials.

Autoren: Hogue O Zelinsky M Sonneborn C et al.

Quelle: Neurology [Neurology] 2025 Nov 11; Vol. 105 (9), pp. e214250. Date of Electronic Publication: 2025 Oct 13.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0401060 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1526-632X (Electronic) Linking ISSN: 00283878 NLM ISO Abbreviation: Neurology Subsets: MEDLINE

MeSH-Schlagworte: Research Design* , Translational Research, Biomedical*/methods , Clinical Trials, Phase II as Topic*, Animals ; Humans ; Multiple Sclerosis/therapy ; Parkinson Disease/therapy ; Epilepsy/therapy ; Disease Models, Animal

crm12comb: Phase I/II adaptive design for drug combinations based on CRM design through R.

Autoren: Wang J Wu S Yang J

Quelle: PloS one [PLoS One] 2025 Nov 10; Vol. 20 (11), pp. e0336146. Date of Electronic Publication: 2025 Nov 10 (Print Publication: 2025).

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE

MeSH-Schlagworte: Clinical Trials, Phase I as Topic*/methods , Clinical Trials, Phase II as Topic*/methods , Software*, Humans ; Bayes Theorem ; Drug Combinations ; Dose-Response Relationship, Drug ; Computer Simulation ; Research Design ; Neoplasms/drug therapy

A retrospective analysis of phase I and phase I/II investigator-initiated clinical trials conducted by the Swiss Group for Clinical Cancer Research (SAKK).

Autoren: Koster KL Colombo I Hayoz S et al.

Quelle: ESMO open [ESMO Open] 2025 Nov; Vol. 10 (11), pp. 105876. Date of Electronic Publication: 2025 Oct 29.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Elsevier Country of Publication: England NLM ID: 101690685 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2059-7029 (Electronic) Linking ISSN: 20597029 NLM ISO Abbreviation: ESMO Open Subsets: MEDLINE

MeSH-Schlagworte: Clinical Trials, Phase I as Topic*/statistics & numerical data , Neoplasms*/drug therapy , Neoplasms*/therapy , Neoplasms*/mortality , Clinical Trials, Phase II as Topic*/statistics & numerical data, Humans ; Retrospective Studies ; Switzerland ; Male ; Female ; Middle Aged ; Aged ; Adult ; Aged, 80 and over

Insufficient diet management and monitoring of patients during phase 2 and 3 pharmaceutical clinical trials: A narrative review with a systematic approach.

Autoren: McWhorter NY Lowe TB Sarasua SM et al.

Quelle: Nutrition (Burbank, Los Angeles County, Calif.) [Nutrition] 2025 Nov; Vol. 139, pp. 112861. Date of Electronic Publication: 2025 Jun 03.

Publikationsart: Journal Article; Systematic Review

Info zur Zeitschrift: Publisher: Elsevier Science Country of Publication: United States NLM ID: 8802712 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-1244 (Electronic) Linking ISSN: 08999007 NLM ISO Abbreviation: Nutrition Subsets: MEDLINE

MeSH-Schlagworte: Clinical Trials as Topic* , Clinical Trials, Phase II as Topic* , Diabetes Mellitus, Type 2*/diet therapy , Diet* , Obesity*/diet therapy , Phenylketonurias*/diet therapy, Humans ; Weight Loss

When Does a Team Start the Discussion on Inclusion and Diversity in Early-phase Clinical Trials?

Autoren: Mathias S Barnes M

Quelle: Clinical therapeutics [Clin Ther] 2025 Nov; Vol. 47 (11), pp. 960-965. Date of Electronic Publication: 2025 Oct 17.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Excerpta Medica Country of Publication: United States NLM ID: 7706726 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-114X (Electronic) Linking ISSN: 01492918 NLM ISO Abbreviation: Clin Ther Subsets: MEDLINE

MeSH-Schlagworte: Patient Selection* , Minority Groups* , Cultural Diversity* , Clinical Trials as Topic* , Clinical Trials, Phase I as Topic*/methods , Clinical Trials, Phase II as Topic*/methods, Humans ; Female ; Drug Development/methods ; Ethnicity ; Quality of Life

An Evaluation of Quality of Life During Participation in Early-Phase Clinical Trials in Paediatric Oncology.

Autoren: Rubio-San-Simón A Buendía S Gómez JR et al.

Quelle: Pediatric blood & cancer [Pediatr Blood Cancer] 2025 Oct; Vol. 72 (10), pp. e31923. Date of Electronic Publication: 2025 Jul 21.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: John Wiley Country of Publication: United States NLM ID: 101186624 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1545-5017 (Electronic) Linking ISSN: 15455009 NLM ISO Abbreviation: Pediatr Blood Cancer Subsets: MEDLINE

MeSH-Schlagworte: Quality of Life* , Neoplasms*/therapy , Neoplasms*/psychology , Clinical Trials, Phase I as Topic* , Clinical Trials, Phase II as Topic* , Patient Participation*, Humans ; Child ; Male ; Female ; Adolescent ; Child, Preschool ; Prospective Studies ; Longitudinal Studies ; Follow-Up Studies

Pharmacometric Model-Based Sample Size Allocation for a Region of Interest in a Multi-Regional Phase 2 Trial: A Case Study of an Anti-Psoriatic Drug.

Autoren: Zhang X Xiao Y Wu J et al.

Quelle: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2025 Oct; Vol. 14 (10), pp. 1673-1681. Date of Electronic Publication: 2025 Aug 01.

Publikationsart: Journal Article; Clinical Trial, Phase II

Info zur Zeitschrift: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE

MeSH-Schlagworte: Psoriasis*/drug therapy , Clinical Trials, Phase II as Topic*/methods, Humans ; Sample Size ; Dose-Response Relationship, Drug ; Research Design

Selection of Quantitative Decision-Making Criteria Using Weighted Decision Error Rates.

Autoren: Bratton DJ; Statistics and Data Science Innovation Hub, GSK, Stevenage, UK.

Quelle: Pharmaceutical statistics [Pharm Stat] 2026 Jan-Feb; Vol. 25 (1), pp. e70057.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print Cited Medium: Internet ISSN: 1539-1612 (Electronic) Linking ISSN: 15391604 NLM ISO Abbreviation: Pharm Stat Subsets: MEDLINE

MeSH-Schlagworte: Decision Making* , Drug Development*/methods , Drug Development*/statistics & numerical data , Clinical Trials, Phase II as Topic*/statistics & numerical data , Clinical Trials, Phase II as Topic*/methods , Clinical Trials, Phase III as Topic*/statistics & numerical data , Clinical Trials, Phase III as Topic*/methods, Humans ; Sample Size ; Research Design/statistics & numerical data

Simulation-Based Bayesian Predictive Probability of Success for Interim Monitoring of Clinical Trials With Competing Event Data: Two Case Studies.

Autoren: Micoli C Crippa A Connor JT et al.

Körperschaften: Micoli C Crippa A Connor JT et al.

Quelle: Pharmaceutical statistics [Pharm Stat] 2026 Jan-Feb; Vol. 25 (1), pp. e70050.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print Cited Medium: Internet ISSN: 1539-1612 (Electronic) Linking ISSN: 15391604 NLM ISO Abbreviation: Pharm Stat Subsets: MEDLINE

MeSH-Schlagworte: Computer Simulation* , Randomized Controlled Trials as Topic*/methods , Randomized Controlled Trials as Topic*/statistics & numerical data , Clinical Trials, Phase II as Topic*/methods , Clinical Trials, Phase II as Topic*/statistics & numerical data , Research Design*, Humans ; Bayes Theorem ; Prostatic Neoplasms/diagnosis ; Prostatic Neoplasms/drug therapy ; Probability ; Male ; COVID-19/therapy ; Models, Statistical ; COVID-19 Drug Treatment

Multiplicity Control in Oncology Clinical Trials With a Binary Surrogate Endpoint-Based Drop-The-Losers Design.

Autoren: Zhong W Liu JO Wang C

Quelle: Statistics in medicine [Stat Med] 2025 Sep; Vol. 44 (20-22), pp. e70209.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: England NLM ID: 8215016 Publication Model: Print Cited Medium: Internet ISSN: 1097-0258 (Electronic) Linking ISSN: 02776715 NLM ISO Abbreviation: Stat Med Subsets: MEDLINE

MeSH-Schlagworte: Research Design* , Endpoint Determination*/methods , Clinical Trials, Phase II as Topic*/methods , Clinical Trials, Phase II as Topic*/statistics & numerical data , Clinical Trials, Phase III as Topic*/methods , Clinical Trials, Phase III as Topic*/statistics & numerical data , Medical Oncology*/methods , Clinical Trials as Topic*/methods, Humans ; Computer Simulation ; Maximum Tolerated Dose ; Lung Neoplasms/drug therapy ; Neoplasms/drug therapy ; Antineoplastic Agents/administration & dosage ; Models, Statistical ; Biomarkers ; Randomized Controlled Trials as Topic/methods ; Software

A Flexible Seamless Phase 2/3 Design With Biomarker-Driven Subgroup Enrichment and Sample Size Re-Estimation.

Autoren: Tian Z Wu L Liu R et al.

Quelle: Pharmaceutical statistics [Pharm Stat] 2025 Sep-Oct; Vol. 24 (5), pp. e70026.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print Cited Medium: Internet ISSN: 1539-1612 (Electronic) Linking ISSN: 15391604 NLM ISO Abbreviation: Pharm Stat Subsets: MEDLINE

MeSH-Schlagworte: Research Design*/statistics & numerical data , Clinical Trials, Phase III as Topic*/methods , Clinical Trials, Phase III as Topic*/statistics & numerical data , Clinical Trials, Phase II as Topic*/methods , Clinical Trials, Phase II as Topic*/statistics & numerical data , Drug Development*/methods , Drug Development*/statistics & numerical data, Humans ; Sample Size ; Biomarkers ; Computer Simulation