Results 21 to 30 of about 41,551 (186)

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

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

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

Data monitoring committees for multicenter clinical trials sponsored by the national institutes of health

Controlled Clinical Trials, 1991
Barbara S Hawkins
openaire   +3 more sources

Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study. [PDF]

, 2006
National Coordinating Centre for Research Methodology; Medical Research Council, UK Department of Health; Chief Scientist OfficeNot peer reviewedPublisher ...
Snowdon, Claire, Grant, Adrian M, Garcia, J, Francis, D, Francis, David, McDonald, Alison Mary, Knight, R.C, Elbourne, Diana, Knight, Rosemary, Elbourne, Diana R., McDonald, A.M, Grant, Adrian, Garcia Jo, Roberts Ian, McDonald Alison M, Elbourne, Diana R, Francis, David; id_orcid, Grant, Adrian Maxwell, McDonald, Alison M, Campbell Marion K, Entwistle, Vikki A, Snowdon, C, Campbell, Marion K, Campbell, M.K, Snowdon Claire, Entwistle, V.A, Campbell, Marion K., Francis David, Entwistle, Vicky, MacDonald, Alison M., McDonald, Alison, Grant, Adrian M., Grant Adrian M, Knight, Rosemary C, Knight, Rosemary C., Entwistle Vikki A, Roberts, Ian, Garcia, Jo, Grant, A.M, Campbell, Marion, Knight Rosemary C, Elbourne Diana R, Entwistle, Vikki A., Elbourne, D.R, Entwistle, Vikki, Campbell, Marion Kay, Roberts, I   +46 more
core   +1 more source

‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact

Trials, 2017
Background The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor.
Anne Daykin, Lucy E. Selman, Helen Cramer, Sharon McCann, Gillian W. Shorter, Matthew R. Sydes, Carrol Gamble, Rhiannon Macefield, J. Athene Lane, Alison Shaw   +9 more
doaj   +1 more source

Establishing a data monitoring committee for clinical trials.

Shanghai archives of psychiatry, 2014
A data monitoring committee (DMC) is a group of clinicians and biostatisticians appointed by study sponsors who provide independent assessment of the safety, scientific validity and integrity of clinical trials. In the United States, the Food and Drug Administration requires the formation of DMC in all trials that assess new interventions. DMC are also
LIN, Julia Y, LU, Ying
openaire   +2 more sources

Accreditation of human research protection program: An Indian perspective

Perspectives in Clinical Research, 2012
With the increasing number of clinical trials being placed in India, it is the collective responsibility of the Investigator sites, Government, Ethics Committees, and Sponsors to ensure that the trial subjects are protected from risks these studies can ...
K L Bairy, Pratibha Pereira
doaj   +1 more source

Trends in mental health clinical research: Characterizing the ClinicalTrials.gov registry from 2007-2018.

PLoS ONE, 2020
While the epidemiologic burden of mental health disorders in the United States has been well described over the past decade, we know relatively little about trends in how these disorders are being studied through clinical research.
Joshua R Wortzel, Brandon E Turner, Brannon T Weeks, Christopher Fragassi, Virginia Ramos, Thanh Truong, Desiree Li, Omar Sahak, Hochang Benjamin Lee   +8 more
doaj   +1 more source

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