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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

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 ...
Calis, Karim, Archdeacon, Patrick, Bain, Raymond, DeMets, David, Donohue, Miriam, Elzarrad, M, Forrest, Annemarie, McEachern, John, Pencina, Michael, Perlmutter, Jane, Lewis, Roger   +10 more
exaly   +8 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 ...
Allaway E, Soulsby I, Keyworth N, Stanton L, Saunders G, Caddy J, Boxall C, Griffiths G.   +7 more
europepmc   +5 more sources

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

European Journal of Heart Failure, 2017
Abstract 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. Generally accepted standards exist for DMC composition and operational conduct.
Filippatos, Gerasimos S., de Graeff, Pieter, Bax, Jeroen J., Borg, John-Joseph, Cleland, John G.F., Dargie, Henry J., Flather, Marcus, Ford, Ian, Friede, Tim, Greenberg, Barry, Henon-Goburdhun, Cécile, Holcomb, Richard, Horst, Bradley, Lekakis, John, Mueller-Velten, Guenther, Papavassiliou, Athanasios G., Prasad, Krishna, Rosano, Giuseppe M.C., Severin, Thomas, Sherman, Warren, Stough, Wendy Gattis, Swedberg, Karl, Tavazzi, Luigi, Tousoulis, Dimitris, Vardas, Panagiotis, Ruschitzka, Frank, Anker, Stefan D.   +26 more
exaly   +11 more sources

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   +6 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   +3 more sources

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

Clin 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.
Eckstein L, Ibrahim A, Orr O, Rid A, Shah SK.   +4 more
europepmc   +3 more sources

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

Sociology of Health & Illness, 2009
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 ...
Keating, Peter, Cambrosio, Alberto
openaire   +5 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

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

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.
Mütze, Tobias, Friede, Tim
openaire   +6 more sources