Výsledky vyhľadávania - "Clinical Trials Data Monitoring Committees"

The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024.

Autori: Welty FK Parhofer KG Konstam M a ďalší

Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 May; Vol. 59 (3), pp. 489-504. Date of Electronic Publication: 2025 Feb 26.

Spôsob vydávania: Journal Article; Review

Informácie 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 zo slovníka MeSH: Benzhydryl Compounds*/therapeutic use , Benzhydryl Compounds*/adverse effects , Glucosides*/therapeutic use , Glucosides*/adverse effects , Randomized Controlled Trials as Topic* , Diabetes Mellitus, Type 2*/drug therapy , Hypoglycemic Agents*/therapeutic use , Hypoglycemic Agents*/adverse effects , Clinical Trials Data Monitoring Committees* , Sodium-Glucose Transporter 2 Inhibitors*/therapeutic use, Humans ; United States ; United States Food and Drug Administration

Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.

Autori: Curtis LH Morain S O'Rourke PP a ďalší

Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2025 May; Vol. 152, pp. 107866. Date of Electronic Publication: 2025 Feb 25.

Spôsob vydávania: Journal Article

Informácie o časopise: 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

Výrazy zo slovníka MeSH: Pragmatic Clinical Trials as Topic*/methods , Pragmatic Clinical Trials as Topic*/standards , Clinical Trials Data Monitoring Committees*/organization & administration, Humans ; United States ; National Institutes of Health (U.S.) ; Research Design ; Data Accuracy

Pragmatic monitoring of emerging efficacy data in randomized controlled trials.

Autori: 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.

Spôsob vydávania: Journal Article

Informácie 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 zo slovníka 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

Interim Clinical Trial Data: Who Can See What, and When?

Autori: Ellenberg SS Li Y

Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 Mar; Vol. 59 (2), pp. 211-214. Date of Electronic Publication: 2025 Jan 08.

Spôsob vydávania: Journal Article

Informácie 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 zo slovníka MeSH: Randomized Controlled Trials as Topic*/methods , Research Design* , Clinical Trials Data Monitoring Committees* , Clinical Trials as Topic*, Humans

Inside the Mind of the DMC: A Review of Principles and Issues with Case Studies.

Autori: Ge L Hamasaki T Evans SR

Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 Mar; Vol. 59 (2), pp. 234-244. Date of Electronic Publication: 2024 Dec 17.

Spôsob vydávania: Journal Article; Review

Informácie 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 zo slovníka MeSH: Clinical Trials as Topic* , Clinical Trials Data Monitoring Committees*, Humans

Data Monitoring Committee Reports: Telling the Data's Story.

Autori: Zeng L Hamasaki T Evans SR

Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 Mar; Vol. 59 (2), pp. 222-233. Date of Electronic Publication: 2024 Dec 10.

Spôsob vydávania: Journal Article; Review

Informácie 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 zo slovníka MeSH: Clinical Trials Data Monitoring Committees*/organization & administration , Clinical Trials as Topic*, Humans

A Sponsor's Best Practice and Operating Principles to Manage Data Monitoring Committees.

Autori: Birck MM Rasmussen JS Helmark IC a ďalší

Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 Mar; Vol. 59 (2), pp. 215-221. Date of Electronic Publication: 2025 Jan 07.

Spôsob vydávania: Journal Article

Informácie 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 zo slovníka MeSH: Clinical Trials Data Monitoring Committees*/organization & administration , Drug Industry*/organization & administration , Clinical Trials as Topic*/standards, Humans ; Quality Control

Ethical Issues Faced by Data Monitoring Committees: Results from an Exploratory Qualitative Study.

Autori: Shah SK Ibrahim A Hinga A a ďalší

Zdroj: Ethics & human research [Ethics Hum Res] 2024 Nov-Dec; Vol. 46 (6), pp. 2-13.

Spôsob vydávania: Journal Article

Informácie o časopise: Publisher: John Wiley & Sons, Inc Country of Publication: United States NLM ID: 101738005 Publication Model: Print Cited Medium: Internet ISSN: 2578-2363 (Electronic) Linking ISSN: 25782355 NLM ISO Abbreviation: Ethics Hum Res Subsets: MEDLINE

Výrazy zo slovníka MeSH: Qualitative Research* , Clinical Trials Data Monitoring Committees*, Humans ; Female ; Male ; Adult ; Ethics, Research ; Decision Making/ethics ; Ethicists ; Middle Aged ; Interviews as Topic

Stakeholders' Perspectives on Current Issues in Data Monitoring Committees.

Autori: Cartwright MJ Friede T Lawrence D a ďalší

Zdroj: Biometrical journal. Biometrische Zeitschrift [Biom J] 2024 Oct; Vol. 66 (7), pp. e202300384.

Spôsob vydávania: Journal Article; Review

Informácie 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 zo slovníka MeSH: Clinical Trials Data Monitoring Committees*, Biometry/methods ; Humans ; Stakeholder Participation

The Case for Access to Data Monitoring Committee Charters.

Autori: Zarin D Wittes JT Fleming TR a ďalší

Zdroj: NEJM evidence [NEJM Evid] 2024 Sep; Vol. 3 (9), pp. EVIDctw2400058. Date of Electronic Publication: 2024 Aug 27.

Spôsob vydávania: Journal Article; Review

Informácie o časopise: Publisher: NEJM Group, a division of the Massachusetts Medical Society Country of Publication: United States NLM ID: 9918317485806676 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2766-5526 (Electronic) Linking ISSN: 27665526 NLM ISO Abbreviation: NEJM Evid Subsets: MEDLINE

Výrazy zo slovníka MeSH: Clinical Trials Data Monitoring Committees*/organization & administration, Humans ; Clinical Trials as Topic ; Access to Information

Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study.

Autori: Hinga A Ibrahim A Vintimilla D a ďalší

Zdroj: BMJ global health [BMJ Glob Health] 2024 Aug 25; Vol. 9 (8). Date of Electronic Publication: 2024 Aug 25.

Spôsob vydávania: Journal Article

Informácie o časopise: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101685275 Publication Model: Electronic Cited Medium: Print ISSN: 2059-7908 (Print) Linking ISSN: 20597908 NLM ISO Abbreviation: BMJ Glob Health Subsets: MEDLINE

Výrazy zo slovníka MeSH: Qualitative Research* , Clinical Trials Data Monitoring Committees*, Humans ; Clinical Trials as Topic/ethics ; Interviews as Topic ; Female ; Male

Training the Next Generation of Data Monitoring Committee Members: An Initiative of the Heart Failure Collaboratory.

Autori: Fleming TR Wittes J Fiuzat M a ďalší

Korporácia: Fleming TR Wittes J Fiuzat M a ďalší

Zdroj: JACC. Heart failure [JACC Heart Fail] 2024 Aug; Vol. 12 (8), pp. 1317-1327. Date of Electronic Publication: 2024 Mar 25.

Spôsob vydávania: Journal Article; Review

Informácie o časopise: Publisher: Elsevier Country of Publication: United States NLM ID: 101598241 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-1787 (Electronic) Linking ISSN: 22131779 NLM ISO Abbreviation: JACC Heart Fail Subsets: MEDLINE

Výrazy zo slovníka MeSH: Heart Failure*/therapy , Clinical Trials Data Monitoring Committees*, Humans ; Clinical Trials as Topic

Data Safety Monitoring Boards: Overview of Structure and Role in Spinal Cord Injury Studies.

Autori: Blight AR Guest JD Hamer J a ďalší

Zdroj: Topics in spinal cord injury rehabilitation [Top Spinal Cord Inj Rehabil] 2024 Summer; Vol. 30 (3), pp. 67-75. Date of Electronic Publication: 2024 Aug 08.

Spôsob vydávania: Journal Article; Review

Informácie o časopise: Publisher: American Spinal Injury Association Country of Publication: United States NLM ID: 9515174 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1945-5763 (Electronic) Linking ISSN: 10820744 NLM ISO Abbreviation: Top Spinal Cord Inj Rehabil Subsets: MEDLINE

Výrazy zo slovníka MeSH: Spinal Cord Injuries* , Clinical Trials Data Monitoring Committees*, Humans ; Clinical Trials as Topic

Shedding light on data monitoring committee charters on ClinicalTrials.gov.

Autori: Fine AM Golfinopoulos E Tse T

Zdroj: Clinical trials (London, England) [Clin Trials] 2024 Apr; Vol. 21 (2), pp. 260-261. Date of Electronic Publication: 2023 Nov 04.

Spôsob vydávania: Letter; Research Support, N.I.H., Intramural; Comment

Informácie 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 zo slovníka MeSH: Clinical Trials Data Monitoring Committees*, Humans

Training New DMC Members: A Call to Action.

Autori: Rockhold F Mahaffey K DeMets D

Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Mar; Vol. 58 (2), pp. 234-235. Date of Electronic Publication: 2023 Sep 25.

Spôsob vydávania: Journal Article

Informácie 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 zo slovníka MeSH: Clinical Trials Data Monitoring Committees* , Mentoring*, Industry ; Inservice Training ; Humans

Data Monitoring Committees and clinical trials: From scientific justification to organisation.

Autori: Locher C Laporte S Derambure P a ďalší

Zdroj: Therapie [Therapie] 2024 Jan-Feb; Vol. 79 (1), pp. 111-121. Date of Electronic Publication: 2023 Dec 05.

Spôsob vydávania: Journal Article

Informácie o časopise: Publisher: Elsevier Masson Country of Publication: France NLM ID: 0420544 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1958-5578 (Electronic) Linking ISSN: 00405957 NLM ISO Abbreviation: Therapie Subsets: MEDLINE

Výrazy zo slovníka MeSH: Clinical Trials Data Monitoring Committees*, Humans ; Odds Ratio

Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov.

Autori: Machado T Mainoli B Caldeira D a ďalší

Zdroj: Clinical trials (London, England) [Clin Trials] 2023 Dec; Vol. 20 (6), pp. 624-631. Date of Electronic Publication: 2023 Jun 27.

Spôsob vydávania: Journal Article

Informácie 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 zo slovníka MeSH: Clinical Trials Data Monitoring Committees* , Research Design*, United States ; Humans ; Child ; Cross-Sectional Studies ; Randomized Controlled Trials as Topic ; National Institutes of Health (U.S.)

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

Autori: Zhang Y Zhang X Wang P a ďalší

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

Spôsob vydávania: Journal Article

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

Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies.

Autori: Zahrieh D Croghan IT Inselman JW a ďalší

Zdroj: Mayo Clinic proceedings [Mayo Clin Proc] 2023 Nov; Vol. 98 (11), pp. 1712-1726.

Spôsob vydávania: Journal Article; Review; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural

Informácie o časopise: Publisher: [Oxford, England] Country of Publication: England NLM ID: 0405543 Publication Model: Print Cited Medium: Internet ISSN: 1942-5546 (Electronic) Linking ISSN: 00256196 NLM ISO Abbreviation: Mayo Clin Proc Subsets: MEDLINE

Výrazy zo slovníka MeSH: Clinical Trials Data Monitoring Committees*, Humans ; Randomized Controlled Trials as Topic

Bringing data monitoring committee charters into the sunlight.

Autori: DeMets DL Zarin DA Rockhold F a ďalší

Zdroj: Clinical trials (London, England) [Clin Trials] 2023 Aug; Vol. 20 (4), pp. 447-451. Date of Electronic Publication: 2023 May 25.

Spôsob vydávania: Journal Article

Informácie 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 zo slovníka MeSH: Clinical Trials Data Monitoring Committees*, Humans