Results 41 to 50 of about 29,514,683 (309)

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

Managing clinical trials. [PDF]

, 2010
Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists ...
Barbara Farrell, Shakur Haleema, Farrell Barbara, Haleema Shakur, Farrell, B, Kenyon, Sara, Shakur, Haleema, Kenyon, Sara; id_orcid, Shakur, H, Kenyon Sara, Sara Kenyon, Farrell, Barbara   +11 more
core   +2 more sources

Infant Embryonal CNS Tumors: Molecular Insights and Treatment Considerations for Contemporary Pediatric Neuro‐Oncology

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Embryonal tumors comprise the majority of malignant central nervous system (CNS) neoplasms diagnosed in children under 3 years of age. Compared with their counterparts in older children, these tumors exhibit distinct molecular biology and a more aggressive clinical phenotype, while their management is complicated by the heightened ...
Sudarshawn Damodharan, Mariah Wright‐Nadkarni, Mohamed S. Abdelbaki, Girish Dhall   +3 more
wiley   +1 more source

Lifestyle InterVention IN Gestational diabetes (LIVING) in India, Bangladesh and Sri Lanka: protocol for process evaluation of a randomised controlled trial

BMJ Open, 2020
Introduction The development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled trial of a ...
Anushka Patel, Stephen Jan, Rohina Joshi, Devarsetty Praveen, Nikhil Tandon, Helena J Teede, Deksha Kapoor, Lakshmi K Josyula, Yashdeep Gupta, Ankush Desai   +9 more
doaj   +1 more source

Addressing the Maternal Mental Health Crisis Through a Novel Tech-Enabled Peer-to-Peer Driven Perinatal Collaborative Care Model

Voices in Bioethics, 2023
Photo by 193001056 © Yee Xin Tan on Dreamstime.com ABSTRACT Suicide and overdose, associated with perinatal mental health conditions, are the leading causes of maternal mortality in the United States.
Bridget McKinney
doaj   +1 more source

Application of methods for central statistical monitoring in clinical trials [PDF]

, 2013
Background On-site source data verification is a common and expensive activity, with little evidence that it is worthwhile. Central statistical monitoring (CSM) is a cheaper alternative, where data checks are performed by the coordinating centre ...
Cox, T, Hackshaw, A, Kirkwood, AA
core  

Global Efforts to Reduce Paediatric Cancer Care Disparities in Radiotherapy: A Decade Change

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background We present an update on the status, needs and challenges faced by paediatric imaging and radiotherapy (RT) programmes globally after a previous survey conducted by the International Atomic Energy Agency (IAEA) 10 years prior. Methods We developed and distributed a 121‐question survey to radiation oncologists, medical physicists and ...
Raymond B. Mailhot Vega, Daniel J. Indelicato, Jeanette Parkes, Natia Esiashvili, Josué Hernández Benítez, Miriam Mikhail‐Lette, Olivera Cirajc Bjelac, Daniel Berger, Eva Ciurana, Yavuz Anacak, Lisbeth Cordero‐Mendez   +10 more
wiley   +1 more source

When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL

Trials, 2018
Background Patient and public involvement (PPI) in clinical trials aims to ensure that research is carried out collaboratively with patients and/or members of the public.
Claire L. Vale, William J. Cragg, Ben Cromarty, Bec Hanley, Annabelle South, Richard Stephens, Kate Sturgeon, Mitzy Gafos   +7 more
doaj   +1 more source

Neuropsychological and Educational Outcomes in Shwachman–Diamond Syndrome—A Report From the North American Shwachman–Diamond Syndrome Registry

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Shwachman–Diamond syndrome (SDS) is a rare autosomal recessive ribosomopathy characterized by bone marrow failure and multisystem involvement, with emerging evidence of associated neurocognitive impairment. Methods We conducted a retrospective study of 240 individuals with biallelic Shwachman–Bodian–Diamond syndrome (SBDS) mutations
Jane Koo, Melissa Gerstle, Leah Cheng, Richard Cooper, Katherine Coyne, Claire Dusa, Naomi E. Joffe, Diana Schwarz, Sarah Steltz, Akiko Shimamura, Kasiani C. Myers, Thea Quinton   +11 more
wiley   +1 more source