Results 31 to 40 of about 41,551 (186)

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

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

Recruitment to randomised trials : Strategies for Trial Enrolment and Participation Study. The STEPS study [PDF]

, 2007
Objectives: To identify factors associated with good and poor recruitment to multicentre trials. Data sources: Part A: database of trials started in or after 1994 and were due to end before 2003 held by the Medical Research Council and Health Technology
Snowdon, Claire, Campbell, MK, McDonald, AM, Garcia, J, Francis, D, McDonald, Alison Mary, Francis, David, J Garcia, Elbourne, Diana R., Grant, A, McDonald, Alison M., R Knight, Elbourne, D, Francis, David; id_orcid, A McDonald, Grant, Adrian Maxwell, Entwistle, V, I Roberts, Snowdon, C, C Snowdon, Campbell, Marion K., D Francis, Grant, Adrian M., STEPS Group, Knight, Rosemary C., Roberts, Ian, Garcia, Jo, A Grant, D Elbourne, Entwistle, Vikki A., Entwistle, Vikki, V Entwistle, Campbell, Marion Kay, Roberts, I, Knight, R, M Campbell   +35 more
core   +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

Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute.

, 1997
PURPOSE To describe the rationale for independent data monitoring committees (DMCs) for National Cancer Institute (NCI)-sponsored phase III cooperative group clinical trials.
E L Korn, R S Ungerleider, R Simon, L Rubinstein, M A Smith   +4 more
core   +1 more source

Current controversies in data monitoring for clinical trials.

, 2006
This article presents some real-life challenges faced by clinical trial Data Monitoring Committees (DMCs), with the aim of clarifying some of the controversial issues that relate to both statistical stopping boundaries and DMC decision-making.
Pocock, Stuart J., Pocock, Stuart J
core   +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