Výsledky vyhledávání - "Clinical Trials"

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

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

Autoři: Hua K Hong H Wang X

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

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 , 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

Impact of Dose-Escalation Design on the Safety and Development of Anticancer Drugs in Clinical Trials.

Autoři: Nonami A Matsuda K Funakoshi K a další

Zdroj: Clinical and translational science [Clin Transl Sci] 2025 Oct; Vol. 18 (10), pp. e70367.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE

Výrazy ze slovníku MeSH: Antineoplastic Agents*/administration & dosage , Antineoplastic Agents*/adverse effects , Clinical Trials, Phase I as Topic*/methods , Drug Development*/methods , Neoplasms*/drug therapy , Research Design*, Humans ; Dose-Response Relationship, Drug ; Maximum Tolerated Dose ; Clinical Trials, Phase II as Topic

Contemporary Characteristics and Outcomes of Pediatric Oncology Patients Participating in Early Phase Clinical Trials.

Autoři: Rami A Bona K Shusterman S a další

Zdroj: Cancer medicine [Cancer Med] 2025 Sep; Vol. 14 (17), pp. e71222.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: John Wiley & Sons Ltd Country of Publication: United States NLM ID: 101595310 Publication Model: Print Cited Medium: Internet ISSN: 2045-7634 (Electronic) Linking ISSN: 20457634 NLM ISO Abbreviation: Cancer Med Subsets: MEDLINE

Výrazy ze slovníku MeSH: Neoplasms*/drug therapy , Neoplasms*/mortality , Clinical Trials, Phase I as Topic*/statistics & numerical data , Antineoplastic Agents*/therapeutic use , Antineoplastic Agents*/adverse effects, Humans ; Child ; Male ; Female ; Child, Preschool ; Adolescent ; Infant ; Young Adult ; Adult ; Infant, Newborn ; Treatment Outcome ; Clinical Trials, Phase II as Topic

Enhancing Clinical Trial Sites in Low- and Middle-Income Countries to Facilitate Product Development in Response to the COVID-19 Pandemic.

Autoři: Kang SSY Tadesse BT Jeon HJ a další

Zdroj: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2025 Jul 22; Vol. 80 (Supplement_1), pp. S1-S8.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE

Výrazy ze slovníku MeSH: COVID-19*/prevention & control , COVID-19*/epidemiology , COVID-19 Vaccines*/supply & distribution , Vaccine Development* , Clinical Trials, Phase III as Topic*, Humans ; Developing Countries ; SARS-CoV-2/immunology ; Capacity Building ; Pandemics/prevention & control ; Philippines ; Ghana ; Nepal ; Clinical Trials as Topic

Pragmatic monitoring of emerging efficacy data in randomized controlled trials.

Autoři: Bangdiwala SI Yusuf S

Zdroj: Clinical trials (London, England) [Clin Trials] 2025 Apr; Vol. 22 (2), pp. 155-160. Date of Electronic Publication: 2024 Nov 09.

Způsob vydávání: Journal Article

Informace o časopise: 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

Výrazy ze slovníku MeSH: Randomized Controlled Trials as Topic*/methods , Clinical Trials, Phase III as Topic*/methods , Clinical Trials Data Monitoring Committees*, Humans ; Research Design ; Pragmatic Clinical Trials as Topic/methods ; Data Interpretation, Statistical ; Early Termination of Clinical Trials

Exclusion of people from oncology clinical trials based on functional status.

Autoři: Agaronnik ND Peters MLB Iezzoni LI

Zdroj: Clinical trials (London, England) [Clin Trials] 2025 Jun; Vol. 22 (3), pp. 367-373. Date of Electronic Publication: 2025 Jan 02.

Způsob vydávání: Journal Article

Informace o časopise: 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

Výrazy ze slovníku MeSH: Neoplasms*/therapy , Patient Selection* , Functional Status* , Clinical Trials as Topic* , Persons with Disabilities*, Humans ; Karnofsky Performance Status ; United States ; Clinical Trials, Phase III as Topic ; United States Food and Drug Administration ; Clinical Trials, Phase IV as Topic

Futility Monitoring in Clinical Trials.

Autoři: Ortega-Villa AM Grieco MC Rubenstein K a další

Zdroj: Statistics in medicine [Stat Med] 2025 Jun; Vol. 44 (13-14), pp. e70157.

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: Medical Futility* , Clinical Trials, Phase III as Topic*/statistics & numerical data , Clinical Trials, Phase III as Topic*/methods , Clinical Trials as Topic*/methods , Clinical Trials as Topic*/statistics & numerical data, Humans ; Data Interpretation, Statistical ; Models, Statistical ; Clinical Trials, Phase II as Topic

A Seamless Hybrid Phase II/III Design With Bayesian Interim Subgroup Selection.

Autoři: Duputel B Stallard N Montestruc F a další

Zdroj: Statistics in medicine [Stat Med] 2025 Jun; Vol. 44 (13-14), pp. e70144.

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, 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 , Research Design*, Humans ; Bayes Theorem ; Computer Simulation ; Logistic Models ; Precision Medicine/methods ; Adaptive Clinical Trials as Topic

A Proposed Confidence Ellipse Approach for Benefit-Risk Assessment in Clinical Trials.

Autoři: Zhang Y Zhang X Wang P a další

Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 May; Vol. 59 (3), pp. 606-618. Date of Electronic Publication: 2025 Mar 03.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

Výrazy ze slovníku MeSH: Clinical Trials as Topic*, Humans ; Risk Assessment/methods ; Clinical Trials Data Monitoring Committees ; United States ; United States Food and Drug Administration ; Confidence Intervals

Provider experiences with and attitudes about an embedded pragmatic clinical trial.

Autoři: Leatherman SM Beaudette-Zlatanova B Robben G a další

Zdroj: BMC primary care [BMC Prim Care] 2025 Apr 23; Vol. 26 (1), pp. 121. Date of Electronic Publication: 2025 Apr 23.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: BioMed Central Ltd Country of Publication: England NLM ID: 9918300889006676 Publication Model: Electronic Cited Medium: Internet ISSN: 2731-4553 (Electronic) Linking ISSN: 27314553 NLM ISO Abbreviation: BMC Prim Care Subsets: MEDLINE

Výrazy ze slovníku MeSH: Attitude of Health Personnel* , Diuretics*/therapeutic use , Pragmatic Clinical Trials as Topic*, Aged ; Female ; Humans ; Male ; Middle Aged ; Primary Health Care ; Randomized Controlled Trials as Topic ; Surveys and Questionnaires ; Clinical Trials, Phase III as Topic

On the finite-sample and asymptotic error control of a randomization-probability test for response-adaptive clinical trials.

Autoři: Deliu N Villar SS

Zdroj: Biometrics [Biometrics] 2025 Apr 02; Vol. 81 (2).

Způsob vydávání: Journal Article

Informace o časopise: Publisher: Oxford University Press Country of Publication: England NLM ID: 0370625 Publication Model: Print Cited Medium: Internet ISSN: 1541-0420 (Electronic) Linking ISSN: 0006341X NLM ISO Abbreviation: Biometrics Subsets: MEDLINE

Výrazy ze slovníku MeSH: Randomized Controlled Trials as Topic*/statistics & numerical data , Randomized Controlled Trials as Topic*/methods , Adaptive Clinical Trials as Topic*/statistics & numerical data , Adaptive Clinical Trials as Topic*/methods, Humans ; Computer Simulation ; Bayes Theorem ; Probability ; Models, Statistical ; Clinical Trials, Phase II as Topic/statistics & numerical data ; Biometry/methods ; Sample Size ; Random Allocation

An Evaluation of Time Spent Completing Electronically Collected Patient-Reported Outcomes in Clinical Trials.

Autoři: Andersen L Williams M Pease S a další

Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 May; Vol. 59 (3), pp. 619-628. Date of Electronic Publication: 2025 Mar 08.

Způsob vydávání: Journal Article

Informace o časopise: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

Výrazy ze slovníku MeSH: Patient Reported Outcome Measures* , Clinical Trials as Topic*, Humans ; Time Factors ; Clinical Trials, Phase II as Topic

On the Concepts, Methods, and Use of "Probability of Success" for Drug Development Decision-Making: A Scoping Review.

Autoři: Cetinyurek Yavuz A Fayyad MBN Jiang C a další

Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2025 Apr; Vol. 117 (4), pp. 967-977. Date of Electronic Publication: 2025 Jan 24.

Způsob vydávání: Journal Article; Scoping Review

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: Drug Development*/methods , Decision Making* , Clinical Trials, Phase III as Topic*/methods, Humans ; Clinical Trials, Phase II as Topic/methods ; Probability ; Research Design

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

Clinical benefit and fragility evaluation of systemic therapy trials for advanced soft tissue sarcoma.

Autoři: Braik D Lemieux C Wilson BE a další

Zdroj: Cancer [Cancer] 2025 Jan 01; Vol. 131 (1), pp. e35564. Date of Electronic Publication: 2024 Sep 18.

Způsob vydávání: Journal Article; Review

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

Výrazy ze slovníku MeSH: Sarcoma*/drug therapy , Sarcoma*/pathology , Clinical Trials, Phase II as Topic*, Humans ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase III as Topic ; Treatment Outcome

The importance of developing reproducible primary endpoints for clinical trials in systemic lupus erythematosus.

Autoři: Yang B Chen Y Jiang J a další

Zdroj: Clinical rheumatology [Clin Rheumatol] 2025 Jan; Vol. 44 (1), pp. 183-192. Date of Electronic Publication: 2024 Nov 23.

Způsob vydávání: Journal Article; Review

Informace o časopise: Publisher: Springer Country of Publication: Germany NLM ID: 8211469 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1434-9949 (Electronic) Linking ISSN: 07703198 NLM ISO Abbreviation: Clin Rheumatol Subsets: MEDLINE

Výrazy ze slovníku MeSH: Lupus Erythematosus, Systemic*/drug therapy , Endpoint Determination* , Clinical Trials as Topic*, Humans ; Severity of Illness Index ; Treatment Outcome ; Reproducibility of Results ; Clinical Trials, Phase II 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

Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift.

Autoři: Mai W Chow SC

Zdroj: Journal of biopharmaceutical statistics [J Biopharm Stat] 2024 Oct; Vol. 34 (6), pp. 993-1006. Date of Electronic Publication: 2024 Mar 21.

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: Endpoint Determination*/statistics & numerical data , Endpoint Determination*/methods , Clinical Trials, Phase III as Topic*/statistics & numerical data , Clinical Trials, Phase III as Topic*/methods , Clinical Trials, Phase II as Topic*/statistics & numerical data , Clinical Trials, Phase II as Topic*/methods, Humans ; Research Design/statistics & numerical data ; Adaptive Clinical Trials as Topic/statistics & numerical data ; Adaptive Clinical Trials as Topic/methods ; Data Interpretation, Statistical ; Models, Statistical ; Drug Development/statistics & numerical data ; Drug Development/methods