Results 31 to 40 of about 41,384 (251)

‘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

"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

Adverse events following immunization against SARS-CoV-2 (covid-19) in the state of Minas Gerais

Revista de Saúde Pública
OBJECTIVE To analyze adverse events following immunization (AEFI) against SARS-CoV-2 (covid-19) in the state of Minas Gerais (MG), Brazil. METHODS Epidemiological, descriptive study, with data from e-SUS Notifica (e-SUS Notification) in the state of ...
Roberta Barros da Silva, Thales Philipe Rodrigues da Silva, Ana Paula Sayuri Sato, Francisco Carlos Felix Lana, Josianne Dias Gusmão, Janaina Fonseca Almeida Souza, Fernanda Penido Matozinhos   +6 more
doaj   +2 more sources

Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study

BMJ Global Health
Introduction A data monitoring committee (DMC) is an independent group of experts who assess the ongoing scientific and ethical integrity of a study through periodic analyses of study data.
Dorcas Kamuya, Annette Rid, Seema K Shah, Alex Hinga, Akram Ibrahim, Diego Vintimilla, Mickayla Jones, Lisa Eckstein   +7 more
doaj   +1 more source

The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias

BMC Medical Research Methodology, 2008
Background Interim analysis of accumulating trial data is important to protect participant safety during randomized controlled trials (RCTs). Data Monitoring Committees (DMCs) often undertake such analyses, but their widening role may lead to extended ...
Hampton John, Calvert Melanie, Tharmanathan Puvan, Freemantle Nick   +3 more
doaj   +1 more source

Long‐Term Outcomes of Patients With Relapsed/Refractory Neuroblastoma Treated on ANBL1221: A Report From the Children's Oncology Group

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Results of COG ANBL1221 changed treatment paradigms for patients with relapsed/refractory neuroblastoma. Chemoimmunotherapy with irinotecan/temozolomide/dinutuximab is now used as both bridge therapy following suboptimal response to induction and as treatment in first relapse.
Elizabeth Sokol, Arlene Naranjo, Lulu Chen, Rajen Mody, Steven G. DuBois, Rochelle Bagatell, Navin Pinto   +6 more
wiley   +1 more source