Results 11 to 20 of about 41,551 (186)

A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials [PDF]

BMC Pediatrics, 2009
Background Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to
van der Lee Johanna H, Fernandes Ricardo M, Offringa Martin   +2 more
doaj   +2 more sources

Clinical outcome assessment trends in clinical trials—Contrasting oncology and non‐oncology trials

Cancer Medicine, 2023
Background Clinical outcome assessments (COAs) are key to patient‐centered evaluation of novel interventions and supportive care. COAs are particularly informative in oncology where a focus on how patients feel and function is paramount, but their ...
Yeonju Kim, Mark R. Gilbert, Terri S. Armstrong, Orieta Celiku   +3 more
doaj   +2 more sources

"You have to keep your nerve on a DMC." Challenges for Data Monitoring Committees in neonatal intensive care trials: Qualitative accounts from the BRACELET Study. [PDF]

PLoS ONE, 2018
BackgroundData Monitoring Committees (DMCs) are essential to the good conduct of many trials. Typically they comprise a small expert group which monitors safety, efficacy, progress and early outcome data as trials recruit.
Claire Snowdon, Peter Brocklehurst, Robert C Tasker, Martin Ward Platt, Diana Elbourne   +4 more
doaj   +2 more sources

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

Therapies
Clinical trials often last several months or even several years. As the trial progresses, it can be tempting to find out whether the data obtained already answers the question posed at the start of the trial in order to stop inclusions or monitoring earlier. However, knowing and taking into account interim results can sometimes compromise the integrity
Locher, Clara, Laporte, Silvy, Derambure, Peggy, Chassany, Olivier, Girault, Cécile, Avakiantz, Alix, Bahans, Claire, Deplanque, Dominique, Fustier, Pierre, Germe, Anne Françoise, Kassai Koupai, Behrouz, Lacoste, Louis, Petitpain, Nadine, Roustit, Matthieu, Simon, Tabassome, Train, Cecile, Cucherat, Michel   +16 more
openaire   +5 more sources

Comprehensive Survey of Clinical Trials Registration for Melanoma Immunotherapy in the ClinicalTrials.gov

Frontiers in Pharmacology, 2020
Objective: Comprehensively evaluate the immunotherapeutic clinical trials and provide reference for melanoma treatment and research.Methods: The website of ClinicalTrials.gov was searched to retrieve and download all registered clinical trials for ...
Yan-Bo Wang, Gang Lv, Feng-Hua Xu, Lin-Lu Ma, Yong-Ming Yao   +4 more
doaj   +1 more source

The disease-specific clinical trial network for primary ciliary dyskinesia: PCD-CTN

ERJ Open Research, 2022
Primary ciliary dyskinesia (PCD) is a rare genetic disorder characterised by impaired mucociliary clearance leading to irreversible lung damage. In contrast to other rare lung diseases like cystic fibrosis (CF), there are only few clinical trials and ...
Johanna Raidt, Bernard Maitre, Petra Pennekamp, Josje Altenburg, Pinelopi Anagnostopoulou, Miguel Armengot, Lizan D. Bloemsma, Mieke Boon, Melissa Borrelli, Folke Brinkmann, Siobhan B. Carr, Mary P. Carroll, Silvia Castillo-Corullón, André Coste, Renato Cutrera, Eleonora Dehlink, Damien M.S. Destouches, Maria E. Di Cicco, Lucy Dixon, Nagehan Emiralioglu, Ela Erdem Eralp, Eric G. Haarman, Claire Hogg, Bulent Karadag, Helene E. Kobbernagel, Natalie Lorent, Marcus A. Mall, June K. Marthin, Vendula Martinu, Manjith Narayanan, Ugur Ozcelik, Daniel Peckham, Massimo Pifferi, Petr Pohunek, Eva Polverino, Simon Range, Felix C. Ringshausen, Evie Robson, Jobst Roehmel, Sandra Rovira-Amigo, Francesca Santamaria, Anne Schlegtendal, Zsolt Szépfalusi, Petra Tempels, Guillaume Thouvenin, Nicola Ullmann, Woolf T. Walker, Martin Wetzke, Panayiotis Yiallouros, Heymut Omran, Kim G. Nielsen   +50 more
doaj   +1 more source

Analysis of regulatory implementation of regulation 536/2014 by European Union countries and Ukraine regarding the examination of clinical trials data and information [PDF]

Pharmacia
The article presents the results of a comparative analysis of regulatory requirements for expertise of clinical trials documentation, submitted for regulatory authority and ethic committees’ approval in EU member countries and Ukraine, outlining the main
Liliia Hala, Oleksandr Nabok
doaj   +3 more sources

sj-xlsx-2-ctj-10.1177_17407745231182417 – Supplemental material for Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov

, 2023
Supplemental material, sj-xlsx-2-ctj-10.1177_17407745231182417 for Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov by Tiago Machado, Beatrice Mainoli, Daniel Caldeira, Joaquim J Ferreira and Ricardo M
Ricardo M Fernandes (8344161), Joaquim J Ferreira (15463262), Tiago Machado (10205649), Beatrice Mainoli (10205646), Daniel Caldeira (4870822)   +4 more
core   +1 more source

Mobile and Wearable Technology for the Monitoring of Diabetes-Related Parameters: Systematic Review

JMIR mHealth and uHealth, 2021
BackgroundDiabetes mellitus is a metabolic disorder that affects hundreds of millions of people worldwide and causes several million deaths every year.
Rodriguez-León, Ciro, Villalonga, Claudia, Munoz-Torres, Manuel, Ruiz, Jonatan R, Banos, Oresti   +4 more
doaj   +1 more source

Enhancing Trial Integrity by Protecting the Independence of Data Monitoring Committees in Clinical Trials [PDF]

Journal of Biopharmaceutical Statistics, 2014
Data monitoring committees (DMCs) have important roles in safeguarding patient interests and enhancing trial integrity and credibility. To effectively fulfill their responsibilities, DMCs should be independent of study sponsors, study investigators, and caregivers managing study participants.
Thomas R, Fleming, Charles H, Hennekens, Marc A, Pfeffer, David L, DeMets   +3 more
openaire   +2 more sources