Results 21 to 30 of about 30,760,747 (299)

‘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

Sharing data from clinical trials: the rationale for a controlled access approach. [PDF]

, 2015
The move towards increased transparency around clinical trials is welcome. Much focus has been on under-reporting of trials and access to individual patient data to allow independent verification of findings.
Parmar, MK, Meredith, SK, Mary Rauchenberger, Matthew R Sydes, Annabelle South, Anthony L Johnson, Mahesh KB Parmar, Sydes, MR, Johnson, AL, South, A, Rauchenberger, M, Sarah K Meredith   +11 more
core   +2 more sources

Pharmacokinetic research in children: an analysis of registered records of clinical trials. [PDF]

, 2011
BACKGROUND: Reported off-label/unlicensed prescribing rates in children range from 11% to 80%. Research into pharmacokinetic profiles of children's medicines is essential in the creation of more knowledge on the safety and efficacy of medicines in ...
Rademaker, Carin MA, Viergever, Roderik F, C. M. A. Rademaker, Ghersi, Davina, D. Ghersi, R. F. Viergever   +5 more
core   +1 more source

Paying clinicians to join clinical trials : a review of guidelines and interview study of trialists [PDF]

, 2009
Background: The motivations of clinicians to participate in clinical trials have been little studied. This project explored the potential role of payment for participation in publicly funded clinical trials in the UK.
Raftery James, Kerr Christine, Hawker, Sheila, Powell John, Powell, John, Hawker Sheila, Raftery, James, Kerr, Christine, John Powell, James Raftery, Christine Kerr, Sheila Hawker   +11 more
core   +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

"You have to keep your nerve on a DMC." Challenges for Data Monitoring Committees in neonatal intensive care trials: Qualitative accounts from the BRACELET Study.

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, Peter Brocklehurst, Robert C Tasker, Martin Ward Platt, Diana Elbourne   +4 more
doaj   +1 more source

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

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, Pilar Modamio, Cecilia Fernández, Eduardo L. Mariño   +3 more
doaj   +1 more source

Stopping at Nothing? Some Dilemmas of Data Monitoring in Clinical Trials

, 2007
This commentary reviews the argument that clinical trials with data monitoring committees that use statistical stopping guidelines should generally not be stopped early for large observed efficacy differences because efficacy estimates may be exaggerated
Goodman, Steven N.
core   +1 more source