Results 21 to 30 of about 100,822 (314)

Data monitoring committees for pragmatic clinical trials [PDF]

Clinical Trials, 2015
In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the ...
Ellenberg, Susan S, Culbertson, Richard, Gillen, Daniel L, Goodman, Steven, Schrandt, Suzanne, Zirkle, Maryan   +5 more
openaire   +4 more sources

Moving fast but going slow: coordination challenges for trials of COVID-19 post-exposure prophylaxis

Trials, 2020
An unprecedented volume of research has been generated in response to the COVID-19 pandemic. However, there are risks of inefficient duplication and of important work being impeded if efforts are not synchronized.
Darrell H. S. Tan, Rupesh Agrawal, Ruanne V. Barnabas, Jon T. Giles, Peter Dull   +4 more
doaj   +1 more source

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

How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis [PDF]

, 2020
Introduction Adaptive designs offer a flexible approach, allowing changes to a trial based on examinations of the data as it progresses. Adaptive clinical trials are becoming a popular choice, as the prudent use of finite research budgets and accurate ...
Brennan, Alan, Flight, Laura, Hind, Daniel, Julious, Steven, Todd, Susan Todd   +4 more
core   +2 more sources

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

Who approves/pays for additional monitoring? [PDF]

, 2019
Major considerations in the provision of healthcare are availability, affordability, accessibility, and appropriateness, especially in the setting of heart failure where disease burden is growing, developments have been rapid and newer biomarkers ...
Adamson, Albert, Atherton, Biering-Sørensen, Boriani, Bristow, Consolo, Cotter, Cotter, Cowie, Cristiana Vitale, Dan, Di Nardo, Dierckx, Dovancescu, Filippatos, Gensini, Giuseppe M C Rosano, Gruson, Harjola, Ilaria Spoletini, Koehler, Kubica, Lefler, Lopatin, Magnussen, Martinson, Masson, McDonald, McDonald, Mollace, Niessner, Olivier, Pellicori, Raatikainen, Raj, Rosano, Rosano, Rosano, Rosano, Salmonson, Swedberg, Tamargo, Vitale, Vonbank, Zannad, Čelutkienė   +46 more
core   +1 more source

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