Results 1 to 10 of about 60,517 (167)

Independent Academic Data Monitoring Committees for Clinical Trials in Cardiovascular and Cardiometabolic Diseases [PDF]

European Journal of Heart Failure, 2017
Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study participants and to maintain a trial's scientific integrity.
Gerasimos Filippatos, John G F Cleland, Henry J Dargie   +2 more
exaly   +17 more sources

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   +5 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   +7 more sources

Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative [PDF]

Clinical Trials, 2017
Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data
David L Demets, Annemarie Forrest
exaly   +6 more sources

Data monitoring committees for clinical trials evaluating treatments of COVID-19 [PDF]

Contemporary Clinical Trials, 2020
The first cases of coronavirus disease 2019 (COVID-19) were reported in December 2019 and the outbreak of SARS-CoV-2 was declared a pandemic in March 2020 by the World Health Organization. This sparked a plethora of investigations into diagnostics and vaccination for SARS-CoV-2, as well as treatments for COVID-19.
Tobias Mütze, Tim Friede
exaly   +6 more sources

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

Therapies, 2023
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
Clara Locher, Silvy Laporte, Peggy Derambure, Olivier Chassany, Cécile Girault, Alix Avakiantz, Claire Bahans, Dominique Deplanque, Pierre Fustier, Anne-Françoise Germe, Behrouz Kassaï, L. Lacoste, Nadine Petitpain, Matthieu Roustit, Tabassome Simon, Cécile Train, Michel Cucherat   +16 more
openalex   +6 more sources

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

BMJ Global Health
Introduction A data monitoring committee (DMC) is an independent group of experts who assess the ongoing scientific and ethical integrity of a study through periodic analyses of study data.
Dorcas Kamuya, Annette Rid, Seema K Shah, Alex Hinga, Akram Ibrahim, Diego Vintimilla, Mickayla Jones, Lisa Eckstein   +7 more
doaj   +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 Thomas, Kwanhye Jung, Hengrui Sun, Matthew A. Psioda, P. Miguel Quibrera, Stephen M. Strakowski   +5 more
openalex   +3 more sources

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

Who's minding the data? Data Monitoring Committees in clinical cancer trials [PDF]

Sociology of Health & Illness, 2008
AbstractModern biomedicine is based on a number of novel institutions and practices that, in order to function, require some degree of formal and informal regulation. This paper contributes to the ongoing investigation of these processes, and the forms of objectivity they generate, by examining the emergence, development and deployment of Data ...
Peter Keating, Alberto Cambrosio
openalex   +4 more sources