Výsledky vyhledávání - "Clinical Trials as Topic"

Use of alternative and confirmatory data in support of rare disease drug development.

Autoři: Chow SC Pariser A Galson S

Zdroj: Journal of biopharmaceutical statistics [J Biopharm Stat] 2025 Oct; Vol. 35 (6), pp. 1005-1019. Date of Electronic Publication: 2025 Apr 11.

Způsob vydávání: Journal Article; Review

Informace o časopise: 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

Výrazy ze slovníku MeSH: Rare Diseases*/drug therapy , Drug Development*/statistics & numerical data , Drug Development*/methods , Orphan Drug Production*/statistics & numerical data , Orphan Drug Production*/methods , Research Design*/statistics & numerical data , Adaptive Clinical Trials as Topic*/statistics & numerical data , Adaptive Clinical Trials as Topic*/methods, Humans ; Data Interpretation, Statistical ; Clinical Trials as Topic/statistics & numerical data ; Clinical Trials as Topic/methods

A Preplanned Multi-Stage Platform Trial for Discovering Multiple Superior Treatments With Control of FWER and Power.

Autoři: Greenstreet P Jaki T Bedding A a další

Zdroj: Biometrical journal. Biometrische Zeitschrift [Biom J] 2025 Feb; Vol. 67 (1), pp. e70025.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: Wiley-VCH Verlag GmbH & Co. KGaA Country of Publication: Germany NLM ID: 7708048 Publication Model: Print Cited Medium: Internet ISSN: 1521-4036 (Electronic) Linking ISSN: 03233847 NLM ISO Abbreviation: Biom J Subsets: MEDLINE

Výrazy ze slovníku MeSH: Biometry*/methods , Clinical Trials as Topic*, Humans ; Sample Size ; Adaptive Clinical Trials as Topic

Clinical trial design for novel targeted agents in neuro-oncology.

Autoři: Lim-Fat MJ Roberto K Wen PY

Zdroj: Journal of neuro-oncology [J Neurooncol] 2025 Jan; Vol. 171 (1), pp. 21-33. Date of Electronic Publication: 2024 Oct 08.

Způsob vydávání: Journal Article; Review

Informace o časopise: Publisher: Springer Country of Publication: United States NLM ID: 8309335 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-7373 (Electronic) Linking ISSN: 0167594X NLM ISO Abbreviation: J Neurooncol Subsets: MEDLINE

Výrazy ze slovníku MeSH: Antineoplastic Agents*/pharmacology , Antineoplastic Agents*/therapeutic use , Brain Neoplasms*/drug therapy , Brain Neoplasms*/mortality , Brain Neoplasms*/pathology , Clinical Trials as Topic* , Research Design*, Humans ; Biomarkers, Tumor/analysis ; Biomarkers, Tumor/metabolism ; Molecular Targeted Therapy/methods ; Adaptive Clinical Trials as Topic

Adaptive designs in clinical trials: a systematic review-part I.

Autoři: Ben-Eltriki M Rafiq A Paul A a další

Zdroj: BMC medical research methodology [BMC Med Res Methodol] 2024 Oct 04; Vol. 24 (1), pp. 229. Date of Electronic Publication: 2024 Oct 04.

Způsob vydávání: Journal Article; Systematic Review

Informace o časopise: Publisher: BioMed Central Country of Publication: England NLM ID: 100968545 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2288 (Electronic) Linking ISSN: 14712288 NLM ISO Abbreviation: BMC Med Res Methodol Subsets: MEDLINE

Výrazy ze slovníku MeSH: Research Design* , Clinical Trials as Topic*/methods , Clinical Trials as Topic*/statistics & numerical data, Humans ; Child ; Adaptive Clinical Trials as Topic/methods ; Adaptive Clinical Trials as Topic/statistics & numerical data ; Adult

Modern trials are most useful when they are pragmatic and explanatory - there is no continuum.

Autoři: Janiaud P Hemkens LG

Zdroj: Journal of clinical epidemiology [J Clin Epidemiol] 2024 Dec; Vol. 176, pp. 111566. Date of Electronic Publication: 2024 Oct 11.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: Elsevier Country of Publication: United States NLM ID: 8801383 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-5921 (Electronic) Linking ISSN: 08954356 NLM ISO Abbreviation: J Clin Epidemiol Subsets: MEDLINE

Výrazy ze slovníku MeSH: Pragmatic Clinical Trials as Topic*/methods , Research Design*, Humans ; Clinical Trials as Topic/methods

Innovative approaches for vaccine trials as a key component of pandemic preparedness - a white paper.

Autoři: Bethe U Pana ZD Drosten C a další

Zdroj: Infection [Infection] 2024 Dec; Vol. 52 (6), pp. 2135-2144. Date of Electronic Publication: 2024 Jul 17.

Způsob vydávání: Journal Article; Review

Informace o časopise: Publisher: Springer Heidelberg Country of Publication: Germany NLM ID: 0365307 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1439-0973 (Electronic) Linking ISSN: 03008126 NLM ISO Abbreviation: Infection Subsets: MEDLINE

Výrazy ze slovníku MeSH: Pandemics*/prevention & control , Clinical Trials as Topic*, Humans ; Vaccines ; Research Design ; COVID-19/prevention & control ; COVID-19/epidemiology ; Pandemic Preparedness ; Adaptive Clinical Trials as Topic

Effects of sceptical priors on the performance of adaptive clinical trials with binary outcomes.

Autoři: Granholm A Lange T Harhay MO a další

Zdroj: Pharmaceutical statistics [Pharm Stat] 2024 Sep-Oct; Vol. 23 (5), pp. 728-741. Date of Electronic Publication: 2024 Mar 29.

Způsob vydávání: Journal Article

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

Výrazy ze slovníku MeSH: Bayes Theorem* , Research Design* , Adaptive Clinical Trials as Topic*/statistics & numerical data , Adaptive Clinical Trials as Topic*/methods , Computer Simulation*, Humans ; Sample Size ; Data Interpretation, Statistical ; Probability ; Models, Statistical ; Clinical Trials as Topic/methods ; Clinical Trials as Topic/statistics & numerical data

Adaptive clinical trial designs for rapid vaccine development: Developing country vaccine manufacturers' perspective.

Autoři: Mahajan M Martin LB Gaurav K a další

Zdroj: Vaccine [Vaccine] 2025 Dec 05; Vol. 68, pp. 127890. Date of Electronic Publication: 2025 Nov 01.

Způsob vydávání: Journal Article; Review

Informace o časopise: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE

Výrazy ze slovníku MeSH: Vaccine Development*/methods , Drug Industry* , Vaccines* , Adaptive Clinical Trials as Topic*/methods , Research Design* , Clinical Trials as Topic*/methods, Humans ; Developing Countries

Advancing Decentralized and Pragmatic Clinical Trials as a Path Toward Improved Representativeness and Greater Generalizability of Clinical Trial Evidence.

Autoři: Marra C Chaiyachati KH Washington V a další

Zdroj: Clinical therapeutics [Clin Ther] 2025 Nov; Vol. 47 (11), pp. 966-970. Date of Electronic Publication: 2025 Aug 21.

Způsob vydávání: Journal Article

Informace o časopise: 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

Výrazy ze slovníku MeSH: Pragmatic Clinical Trials as Topic*/methods , Clinical Trials as Topic*/methods , Patient Selection*, Humans ; Research Design

Practical guidance for conducting high-quality and rapid interim analyses in adaptive clinical trials.

Autoři: Mossop H Walmsley Z Wilson N a další

Zdroj: BMC medicine [BMC Med] 2025 Oct 01; Vol. 23 (1), pp. 528. Date of Electronic Publication: 2025 Oct 01.

Způsob vydávání: Journal Article; Review

Informace o časopise: Publisher: BioMed Central Country of Publication: England NLM ID: 101190723 Publication Model: Electronic Cited Medium: Internet ISSN: 1741-7015 (Electronic) Linking ISSN: 17417015 NLM ISO Abbreviation: BMC Med Subsets: MEDLINE

Výrazy ze slovníku MeSH: Research Design*/standards , Adaptive Clinical Trials as Topic*/methods , Adaptive Clinical Trials as Topic*/standards , Clinical Trials as Topic*/methods , Clinical Trials as Topic*/standards, Humans

An Approach to Design Adaptive Clinical Trials With Time-to-Event Outcomes Based on a General Bayesian Posterior Distribution.

Autoři: McGree JM Overstall AM Jones M a další

Zdroj: Statistics in medicine [Stat Med] 2025 Oct; Vol. 44 (23-24), pp. e70207.

Způsob vydávání: Journal Article

Informace o časopise: 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

Výrazy ze slovníku MeSH: Adaptive Clinical Trials as Topic*/methods , Research Design* , Clinical Trials as Topic*/methods, Bayes Theorem ; Humans ; Computer Simulation ; Models, Statistical ; Gastroenteritis/prevention & control ; Likelihood Functions ; Treatment Outcome ; Infant

An improved biomarker-guided adaptive patient enrichment design for oncology trials.

Autoři: Zhou Z Teng Z Zhu J a další

Zdroj: Journal of biopharmaceutical statistics [J Biopharm Stat] 2025 Oct; Vol. 35 (6), pp. 1227-1243. Date of Electronic Publication: 2025 Apr 23.

Způsob vydávání: Journal Article

Informace o časopise: 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

Výrazy ze slovníku MeSH: Research Design*/statistics & numerical data , Neoplasms*/drug therapy , Neoplasms*/therapy , Neoplasms*/metabolism , Biomarkers, Tumor* , Clinical Trials as Topic*/methods , Clinical Trials as Topic*/statistics & numerical data , Medical Oncology*/statistics & numerical data , Medical Oncology*/methods , Adaptive Clinical Trials as Topic*/statistics & numerical data , Adaptive Clinical Trials as Topic*/methods, Humans ; Computer Simulation ; Sample Size ; Models, Statistical ; Biomarkers

Sample size recalculation in three-stage clinical trials and its evaluation.

Autoři: Bokelmann B Rauch G Meis J a další

Zdroj: BMC medical research methodology [BMC Med Res Methodol] 2024 Sep 25; Vol. 24 (1), pp. 214. Date of Electronic Publication: 2024 Sep 25.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: BioMed Central Country of Publication: England NLM ID: 100968545 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2288 (Electronic) Linking ISSN: 14712288 NLM ISO Abbreviation: BMC Med Res Methodol Subsets: MEDLINE

Výrazy ze slovníku MeSH: Clinical Trials as Topic*/methods , Clinical Trials as Topic*/statistics & numerical data , Research Design*/statistics & numerical data, Sample Size ; Humans ; Computer Simulation ; Adaptive Clinical Trials as Topic

Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.

Autoři: Fortney JC Curran GM Lyon AR a další

Zdroj: Journal of general internal medicine [J Gen Intern Med] 2024 Jul; Vol. 39 (9), pp. 1735-1743. Date of Electronic Publication: 2024 Apr 16.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: Springer Country of Publication: United States NLM ID: 8605834 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1525-1497 (Electronic) Linking ISSN: 08848734 NLM ISO Abbreviation: J Gen Intern Med Subsets: MEDLINE

Výrazy ze slovníku MeSH: Pragmatic Clinical Trials as Topic*/methods, Humans ; Clinical Trials as Topic/methods ; Clinical Trials as Topic/standards ; Evidence-Based Medicine/methods ; Evidence-Based Medicine/standards ; Research Design

Regulatory Issues of Platform Trials: Learnings from EU-PEARL.

Autoři: Nguyen QL Hees K Hernandez Penna S a další

Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Jul; Vol. 116 (1), pp. 52-63. Date of Electronic Publication: 2024 Mar 26.

Způsob vydávání: Journal Article; Review; Research Support, Non-U.S. Gov't

Informace o časopise: Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE

Výrazy ze slovníku MeSH: European Union* , Clinical Trials as Topic*/legislation & jurisprudence , Clinical Trials as Topic*/methods , Clinical Trials as Topic*/standards , United States Food and Drug Administration* , Drug Development*/legislation & jurisprudence , Drug Development*/methods, Humans ; United States ; Research Design ; Guidelines as Topic ; Technology Assessment, Biomedical/legislation & jurisprudence ; Adaptive Clinical Trials as Topic

Two-Stage Drop-the-Losers Design for the Selection of Effective Treatments and Estimating Their Average Worth.

Autoři: Katariya Y Misra N

Zdroj: Statistics in medicine [Stat Med] 2025 Dec; Vol. 44 (28-30), pp. e70344.

Způsob vydávání: Journal Article

Informace o časopise: 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

Výrazy ze slovníku MeSH: Research Design* , Clinical Trials as Topic*/methods , Clinical Trials as Topic*/statistics & numerical data , Randomized Controlled Trials as Topic*/methods, Humans ; Computer Simulation ; Models, Statistical ; Treatment Outcome

Covariate-Adjusted Group Sequential Comparisons of Survival Probabilities.

Autoři: Zhang P Logan B Martens MJ

Zdroj: Statistics in medicine [Stat Med] 2025 Dec; Vol. 44 (28-30), pp. e70339.

Způsob vydávání: Journal Article

Informace o časopise: 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

Výrazy ze slovníku MeSH: Clinical Trials as Topic*/statistics & numerical data , Clinical Trials as Topic*/methods, Humans ; Proportional Hazards Models ; Survival Analysis ; Computer Simulation ; Models, Statistical ; Probability ; Bone Marrow Transplantation ; Data Interpretation, Statistical

Graph Based, Adaptive, Multiarm, Multiple Endpoint, Two-Stage Designs.

Autoři: Mehta C Mukhopadhyay A Posch M

Zdroj: Statistics in medicine [Stat Med] 2025 Dec; Vol. 44 (28-30), pp. e70237.

Způsob vydávání: Journal Article

Informace o časopise: 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

Výrazy ze slovníku MeSH: Research Design* , Endpoint Determination*/methods , Endpoint Determination*/statistics & numerical data , Clinical Trials as Topic*/methods , Clinical Trials as Topic*/statistics & numerical data, Humans ; Computer Simulation ; Sample Size ; Models, Statistical ; Data Interpretation, Statistical

Clinical trials for older cancer patients: A systematic review.

Autoři: Fazio R Audisio A Bregni G a další

Zdroj: Cancer treatment reviews [Cancer Treat Rev] 2025 Dec; Vol. 141, pp. 103045. Date of Electronic Publication: 2025 Nov 04.

Způsob vydávání: Journal Article; Systematic Review; Review

Informace o časopise: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 7502030 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1967 (Electronic) Linking ISSN: 03057372 NLM ISO Abbreviation: Cancer Treat Rev Subsets: MEDLINE

Výrazy ze slovníku MeSH: Neoplasms*/therapy , Clinical Trials as Topic*/statistics & numerical data , Clinical Trials as Topic*/methods , Patient Selection*, Humans ; Aged ; Quality of Life ; Aged, 80 and over ; Geriatric Assessment ; Age Factors

Statistical innovations in clinical trial design with a focus on drug combinations, factorials, and other multiple therapy issues.

Autoři: Berry DA; Division of Discovery Science, Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: don@berryconsultants.net.

Zdroj: The journal of prevention of Alzheimer's disease [J Prev Alzheimers Dis] 2025 Dec; Vol. 12 (10), pp. 100392. Date of Electronic Publication: 2025 Oct 27.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: Elsevier Country of Publication: United States NLM ID: 101638820 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2426-0266 (Electronic) Linking ISSN: 22745807 NLM ISO Abbreviation: J Prev Alzheimers Dis Subsets: MEDLINE

Výrazy ze slovníku MeSH: Research Design* , Clinical Trials as Topic*/methods , Clinical Trials as Topic*/statistics & numerical data, Humans ; Bayes Theorem ; Drug Combinations ; Drug Therapy, Combination