Results 11 to 20 of about 30,760,747 (299)

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

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
core   +11 more sources

sj-xlsx-2-ctj-10.1177_17407745231182417 – Supplemental material for Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov

, 2023
Supplemental material, sj-xlsx-2-ctj-10.1177_17407745231182417 for Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov by Tiago Machado, Beatrice Mainoli, Daniel Caldeira, Joaquim J Ferreira and Ricardo M
Ricardo M Fernandes (8344161), Joaquim J Ferreira (15463262), Tiago Machado (10205649), Beatrice Mainoli (10205646), Daniel Caldeira (4870822)   +4 more
core   +1 more source

sj-docx-1-ctj-10.1177_17407745231182417 – Supplemental material for Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov

, 2023
Supplemental material, sj-docx-1-ctj-10.1177_17407745231182417 for Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov by Tiago Machado, Beatrice Mainoli, Daniel Caldeira, Joaquim J Ferreira and Ricardo M
Ricardo M Fernandes (8344161), Joaquim J Ferreira (15463262), Tiago Machado (10205649), Beatrice Mainoli (10205646), Daniel Caldeira (4870822)   +4 more
core   +1 more source

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   +3 more sources

Monitoring committees for research participant protection

, 2022
Of increasingly relevance in public health and research projects involving human beings, the topic of safety has been intensely discussed. Participants in clinical trials are subject to risks, physical or otherwise, that impact their integrity, rights ...
Marcelo Nobile Franco (14656338), Marisa Palacios (12659528), Beatriz Kaippert (14656341)   +2 more
core   +1 more source

Monitoring antimalarial safety and tolerability in clinical trials: a case study from Uganda. [PDF]

, 2008
BACKGROUND: New antimalarial regimens, including artemisinin-based combination therapies (ACTs), have been adopted widely as first-line treatment for uncomplicated malaria.
Njama-Meya Denise, Staedke Sarah G, Catherine Maiteki-Sebuguzi, Sarah G Staedke, Denise Njama-Meya, Moses R Kamya, Kristin Banek, Maiteki-Sebuguzi Catherine, Grant Dorsey, Yeka Adoke, Jagannathan, Prasanna, Dorsey, Grant, Talisuna, Ambrose O, Arthur Mpimbaza, Dorsey Grant, Ambrose O Talisuna, Rosenthal Philip J, Hasifa Bukirwa, Jagannathan Prasanna, Maiteki-Sebuguzi, Catherine, Rosenthal, Philip J, Tamara D Clark, Clark Tamara D, Yeka, Adoke, Banek, Kristin, Nzarubara Bridget, Staedke, Sarah G, Prasanna Jagannathan, Banek Kristin, Mpimbaza Arthur, Bukirwa, Hasifa, Nzarubara, Bridget, Philip J Rosenthal, Njama-Meya, Denise, Clark, Tamara D, Adoke Yeka, Mpimbaza, Arthur, Kamya Moses R, Bridget Nzarubara, Kamya, Moses R, Bukirwa Hasifa, Wabwire-Mangen Fred, Talisuna Ambrose O, Fred Wabwire-Mangen, Wabwire-Mangen, Fred   +44 more
core   +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