Results 11 to 20 of about 41,480 (249)

Importance and role of independent data monitoring committees (IDMCs) in oncology clinical trials [PDF]

BMJ Open, 2021
The role and use of independent data monitoring committees (IDMCs) has evolved over the past decades. The Food and Drug Administration and European Medicines Agency have issued guidelines on the role and functioning of such committees.
P Schöffski
doaj   +6 more sources

Including patient and public contributors on clinical trial Independent Data Monitoring Committees (IDMCs) [PDF]

Trials
Background and aims Patient and public involvement (PPI) is well established in clinical trials and trial oversight groups in the UK. But public contributors are rarely involved in Independent Data Monitoring Committees (IDMCs), meaning there is little ...
Elizabeth Allaway, Irene Soulsby, Nicole Keyworth, Louise Stanton, Geoff Saunders, Joshua Caddy, Cherish Boxall, Gareth Griffiths   +7 more
doaj   +4 more sources

Charting the content of data monitoring committee charters for clinical trials [PDF]

Clinical Trials
Background: Data monitoring committees play a critical role in ensuring the ethical conduct of clinical trials. Data monitoring committee charters set out the role and processes for data monitoring committees in monitoring clinical trials; however, little is known about the information charters contain.
Lisa Eckstein, Akram Ibrahim, Olivia Orr, Annette Rid, Seema K Shah   +4 more
openaire   +3 more sources

Approach to the state of the art of data monitoring committees in clinical trials

Revista Cubana de Medicina Militar, 2021
Introduction: For the first time, in 1967, a data monitoring committee was established in a study of cardiovascular mortality. Since then its use has increased, due to its value to guarantee the safety of subjects participating in clinical trials, the ...
Sonia Pérez Rodríguez, Héctor Lázaro Lara Fernández, Selma Arteaga Cantón, Meiby de la Caridad Rodríguez González, Maura Tamayo Rodríguez   +4 more
doaj   +1 more source

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

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