Results 21 to 30 of about 41,384 (251)

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

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   +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

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

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   +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

Enhancing clarity of clinical trial safety reports for data monitoring committees [PDF]

Journal of Biopharmaceutical Statistics, 2020
A Data Monitoring Committee (DMC) evaluates patient safety in a clinical trial of an investigational intervention through periodic review of adverse events (AEs) and clinical safety assessments. Our aim was to construct DMC report displays to enhance the DMC safety review through use of graphics and clear identification and adjustment for missing data ...
Sonia M. Thomas, Kwanhye Jung, Hengrui Sun, Matthew A. Psioda, Pedro Miguel Quibrera, Stephen M. Strakowski   +5 more
openaire   +2 more sources

Implications of product withdrawal on a post-approval pragmatic trial: The VOLUME study experience

Contemporary Clinical Trials Communications, 2019
Introduction: Many clinical trials terminate early due to safety and efficacy concerns, and less often due to unexpected “positive” findings. However, early termination of post-approval (Phase IV) pragmatic randomized trials for commercial reasons is ...
Francesca M. Kolitsopoulos, Nicolle M. Gatto, Kevin Sweetland, Michael B. Bracken, Neville Jackson   +4 more
doaj   +1 more source

Data monitoring committees for multicenter clinical trials sponsored by the national institutes of health

Controlled Clinical Trials, 1991
Barbara S Hawkins
openaire   +3 more sources