Suchergebnisse - "Clinical Trials, Phase III as Topic"

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

Bayesian interim analysis and efficiency of phase III randomized trials.

Autoren: Sherry AD Msaouel P Miller AM et al.

Quelle: British journal of cancer [Br J Cancer] 2025 Nov; Vol. 133 (8), pp. 1145-1151. Date of Electronic Publication: 2025 Aug 11.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Nature Publishing Group on behalf of Cancer Research UK Country of Publication: England NLM ID: 0370635 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1827 (Electronic) Linking ISSN: 00070920 NLM ISO Abbreviation: Br J Cancer Subsets: MEDLINE

MeSH-Schlagworte: Clinical Trials, Phase III as Topic*/methods , Clinical Trials, Phase III as Topic*/statistics & numerical data , Randomized Controlled Trials as Topic*/methods , Neoplasms*/drug therapy , Neoplasms*/therapy, Bayes Theorem ; Humans

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.)

[Generalisability of Phase III Clinical Trials Using the Example of Two German Multiple Sclerosis Registries].

Transliterierter Titel: Generalisierbarkeit von Phase III Klinischen Studien am Beispiel Zweier Bundesweiter Multiple Sklerose Register.

Autoren: Jalusic KO Ellenberger D Stahmann A et al.

Quelle: Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)) [Gesundheitswesen] 2025 Dec; Vol. 87 (12), pp. 767-776. Date of Electronic Publication: 2025 Feb 15.

Publikationsart: Journal Article; Multicenter Study; English Abstract

Info zur Zeitschrift: Publisher: Thieme Country of Publication: Germany NLM ID: 9204210 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1439-4421 (Electronic) Linking ISSN: 09413790 NLM ISO Abbreviation: Gesundheitswesen Subsets: MEDLINE

MeSH-Schlagworte: Registries*/statistics & numerical data , Multiple Sclerosis*/epidemiology , Multiple Sclerosis*/drug therapy , Clinical Trials, Phase III as Topic*/statistics & numerical data , Patient Selection*, Humans ; Germany/epidemiology ; Male ; Female ; Adult ; Middle Aged ; Young Adult ; Treatment Outcome

Overlooked and underreported: A systematic review of quality of life in recent Phase III metastatic breast cancer trials.

Autoren: Kalantri S Sainatham C Tallapalli JR et al.

Quelle: Journal of cancer policy [J Cancer Policy] 2025 Dec; Vol. 46, pp. 100653. Date of Electronic Publication: 2025 Oct 21.

Publikationsart: Journal Article; Systematic Review; Review

Info zur Zeitschrift: Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101639933 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-5383 (Electronic) Linking ISSN: 22135383 NLM ISO Abbreviation: J Cancer Policy Subsets: MEDLINE

MeSH-Schlagworte: Quality of Life* , Breast Neoplasms*/pathology , Breast Neoplasms*/therapy , Breast Neoplasms*/psychology , Clinical Trials, Phase III as Topic*, Humans ; Female ; Randomized Controlled Trials as Topic ; Neoplasm Metastasis

Study Endpoint Fulfillment and FDA Approval Success in Phase III Clinical Trials of Genitourinary Malignancies.

Autoren: Steidle M Malshy K Hunt TC et al.

Quelle: Clinical genitourinary cancer [Clin Genitourin Cancer] 2025 Dec; Vol. 23 (6), pp. 102436. Date of Electronic Publication: 2025 Sep 14.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Elsevier Country of Publication: United States NLM ID: 101260955 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1938-0682 (Electronic) Linking ISSN: 15587673 NLM ISO Abbreviation: Clin Genitourin Cancer Subsets: MEDLINE

MeSH-Schlagworte: Clinical Trials, Phase III as Topic* , Drug Approval* , Urogenital Neoplasms*/mortality , Urogenital Neoplasms*/therapy , Prostatic Neoplasms*/drug therapy , Prostatic Neoplasms*/mortality , Endpoint Determination*, Humans ; United States ; Male ; United States Food and Drug Administration ; Kidney Neoplasms/drug therapy ; Kidney Neoplasms/mortality ; Urinary Bladder Neoplasms/drug therapy ; Female

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

Protocol for the development of a Core Outcome Set (COS) for reporting outcomes of clinical trials of anti-tuberculosis treatment in adults with pulmonary tuberculosis.

Autoren: Thomas R Harman NL Williamson PR et al.

Körperschaften: Thomas R Harman NL Williamson PR et al.

Quelle: Trials [Trials] 2025 Nov 18; Vol. 26 (1), pp. 521. Date of Electronic Publication: 2025 Nov 18.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

MeSH-Schlagworte: Tuberculosis, Pulmonary*/drug therapy , Tuberculosis, Pulmonary*/diagnosis , Antitubercular Agents*/therapeutic use , Antitubercular Agents*/adverse effects , Endpoint Determination*/standards , Clinical Trials, Phase III as Topic*/standards, Humans ; Delphi Technique ; Research Design ; Treatment Outcome ; Systematic Reviews as Topic ; Consensus ; Adult

Adherence of published randomised Phase 3 cancer trials to principles proposed by common-sense oncology.

Autoren: Abdihamid O Gyawali B Booth CM et al.

Quelle: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2025 Nov 17; Vol. 230, pp. 116041. Date of Electronic Publication: 2025 Oct 04.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 9005373 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0852 (Electronic) Linking ISSN: 09598049 NLM ISO Abbreviation: Eur J Cancer Subsets: MEDLINE

MeSH-Schlagworte: Neoplasms*/therapy , Neoplasms*/mortality , Randomized Controlled Trials as Topic*/standards , Clinical Trials, Phase III as Topic*/standards , Medical Oncology*/standards , Research Design*/standards , Guideline Adherence*, Humans ; Checklist ; Quality of Life

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

Design and analysis of randomized clinical trials of embryo diagnostics: phase 3.

Autoren: Wilkinson J Goodman LR Hill MJ et al.

Quelle: Fertility and sterility [Fertil Steril] 2025 Nov 01; Vol. 124 (5 Pt 1), pp. 849-859.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Elsevier for the American Society for Reproductive Medicine Country of Publication: United States NLM ID: 0372772 Publication Model: Print Cited Medium: Internet ISSN: 1556-5653 (Electronic) Linking ISSN: 00150282 NLM ISO Abbreviation: Fertil Steril Subsets: MEDLINE

MeSH-Schlagworte: Randomized Controlled Trials as Topic*/methods , Research Design* , Preimplantation Diagnosis*/methods , Clinical Trials, Phase III as Topic*/methods, Humans ; Female ; Pregnancy

Eligibility criteria in phase 3 randomized controlled trials in gastric cancer.

Autoren: Marcisz-Grzanka K Kłosowska D Harhala M et al.

Quelle: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association [Gastric Cancer] 2025 Nov; Vol. 28 (6), pp. 1232-1240. Date of Electronic Publication: 2025 Sep 11.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Springer-Verlag Tokyo Country of Publication: Japan NLM ID: 100886238 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1436-3305 (Electronic) Linking ISSN: 14363291 NLM ISO Abbreviation: Gastric Cancer Subsets: MEDLINE

MeSH-Schlagworte: Stomach Neoplasms*/therapy , Clinical Trials, Phase III as Topic*/standards , Randomized Controlled Trials as Topic*/standards , Patient Selection* , Eligibility Determination*, Humans ; Aged ; Aged, 80 and over ; Male ; Female

What's a migraine day? Analysis of the variety in the definition of a migraine day across phase III trials with drugs targeting the CGRP pathway.

Autoren: Loose L Paemeleire K Goadsby PJ et al.

Quelle: Cephalalgia : an international journal of headache [Cephalalgia] 2025 Nov; Vol. 45 (11), pp. 3331024251393986. Date of Electronic Publication: 2025 Nov 05.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Sage Country of Publication: England NLM ID: 8200710 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1468-2982 (Electronic) Linking ISSN: 03331024 NLM ISO Abbreviation: Cephalalgia Subsets: MEDLINE

MeSH-Schlagworte: Migraine Disorders*/drug therapy , Migraine Disorders*/diagnosis , Migraine Disorders*/metabolism , Calcitonin Gene-Related Peptide*/metabolism , Calcitonin Gene-Related Peptide*/antagonists & inhibitors , Clinical Trials, Phase III as Topic*/methods, Humans ; Calcitonin Gene-Related Peptide Receptor Antagonists/therapeutic use ; Randomized Controlled Trials as Topic

Applicability of phase 3 trial selection criteria to real-world transthyretin amyloid cardiomyopathy patients.

Autoren: Poledniczek M Schmid LM Kronberger C et al.

Quelle: Scientific reports [Sci Rep] 2025 Oct 29; Vol. 15 (1), pp. 37893. Date of Electronic Publication: 2025 Oct 29.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE

MeSH-Schlagworte: Amyloid Neuropathies, Familial*/mortality , Cardiomyopathies*/mortality , Patient Selection* , Clinical Trials, Phase III as Topic*, Humans ; Female ; Male ; Aged ; Aged, 80 and over ; Prospective Studies ; Prealbumin

SCR Disease Name: Amyloidosis, Hereditary, Transthyretin-Related

Comorbidities, safety and persistence in phase III clinical trials in multiple sclerosis.

Autoren: Salter A Lancia S Kowalec K et al.

Quelle: Journal of neurology, neurosurgery, and psychiatry [J Neurol Neurosurg Psychiatry] 2025 Oct 15; Vol. 96 (11), pp. 1070-1076. Date of Electronic Publication: 2025 Oct 15.

Publikationsart: Journal Article; Meta-Analysis

Info zur Zeitschrift: Publisher: BMJ Publishing Group Country of Publication: England NLM ID: 2985191R Publication Model: Electronic Cited Medium: Internet ISSN: 1468-330X (Electronic) Linking ISSN: 00223050 NLM ISO Abbreviation: J Neurol Neurosurg Psychiatry Subsets: MEDLINE

MeSH-Schlagworte: Multiple Sclerosis*/drug therapy , Multiple Sclerosis*/epidemiology , Clinical Trials, Phase III as Topic*, Humans ; Comorbidity

Documentation of patient withdrawals, retention strategies, and postwithdrawal data practices in cancer clinical trials.

Autoren: Karol AB Paredes R Argulian A et al.

Quelle: Cancer [Cancer] 2025 Oct 01; Vol. 131 (19), pp. e70106.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: United States NLM ID: 0374236 Publication Model: Print Cited Medium: Internet ISSN: 1097-0142 (Electronic) Linking ISSN: 0008543X NLM ISO Abbreviation: Cancer Subsets: MEDLINE

MeSH-Schlagworte: Neoplasms*/therapy , Clinical Trials, Phase III as Topic*/statistics & numerical data , Patient Dropouts*/statistics & numerical data , Documentation*, Humans ; Cross-Sectional Studies ; Male ; Female

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

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

Sample Size for Enriched Biomarker Designs With Measurement Error for Time-to-Event Outcomes.

Autoren: Guo S Halabi S Liu A

Quelle: Pharmaceutical statistics [Pharm Stat] 2025 Sep-Oct; Vol. 24 (5), pp. e70027.

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 , Randomized Controlled Trials as Topic*/methods , Randomized Controlled Trials as Topic*/statistics & numerical data , Clinical Trials, Phase III as Topic*/methods , Clinical Trials, Phase III as Topic*/statistics & numerical data , Biomarkers*/analysis, Humans ; Sample Size ; Prostatic Neoplasms/drug therapy ; Precision Medicine/methods ; Male ; Biomarkers, Tumor