Results 21 to 30 of about 41,480 (249)
Mobile and Wearable Technology for the Monitoring of Diabetes-Related Parameters: Systematic Review
JMIR mHealth and uHealth, 2021 BackgroundDiabetes mellitus is a metabolic disorder that affects hundreds of millions of people worldwide and causes several million deaths every year.
Rodriguez-León, Ciro +4 more
doaj +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 +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 +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 +4 more
doaj +1 more source
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 +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
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 +8 more
doaj +1 more source
PLoS ONE, 2018 BackgroundData Monitoring Committees (DMCs) are essential to the good conduct of many trials. Typically they comprise a small expert group which monitors safety, efficacy, progress and early outcome data as trials recruit.
Claire Snowdon +4 more
doaj +1 more source
Frontiers in Pharmacology, 2017 The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have
Ignacio Segarra +3 more
doaj +1 more source