Results 21 to 30 of about 3,635,661 (309)

Implementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system

Trials, 2019
Background Triggered monitoring in clinical trials is a risk-based monitoring approach where triggers (centrally monitored, predefined key risk and performance indicators) drive the extent, timing, and frequency of monitoring visits.
Carlos Diaz-Montana, William J. Cragg, Rahela Choudhury, Nicola Joffe, Matthew R. Sydes, Sally P. Stenning   +5 more
doaj   +1 more source

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial

Trials, 2020
Background Safety data is required to be collected in all clinical trials and can be separated into two types of data, adverse events and serious adverse events.
Elizabeth C. James, David Dunn, Adrian D. Cook, Andrew R. Clamp, Matthew R. Sydes   +4 more
doaj   +1 more source

The COV-ED Survey: exploring the impact of learning and teaching from home on parent/carers’ and teachers’ mental health and wellbeing during COVID-19 lockdown

BMC Public Health, 2022
Background Following the emergence of COVID-19 in the UK, on March 18th 2020 the majority of schools in England closed and families and teachers were tasked with providing educational support for children and adolescents within the home environment ...
C Connor, N De Valliere, J Warwick, S Stewart-Brown, A Thompson   +4 more
doaj   +1 more source

Responder Identification in Clinical Trials with Censored Data [PDF]

, 2003
We present a newly developed technique for identification of positive and negative responders to a new treatment which was compared to a classical treatment (or placebo) in a randomized clinical trial.
Kehl, V., Ulm, Kurt
core   +2 more sources

A multisite study of performance drivers among institutional review boards. [PDF]

, 2017
Introduction:The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors
Allen, Karen, Buscher, Nate, Caligiuri, Michael, Denney, Lisa, Firestein, Gary S, Fontanesi, John, Gates, Cynthia, Kantelo, Kip, Magit, Anthony, Sak, Rachael   +9 more
core   +1 more source

Representation of South Asian people in randomised clinical trials: analysis of trials' data [PDF]

, 2003
Excluding patients of ethnic minority groups from clinical trials is unethical, introduces substantial bias, and means that findings are based on unrepresentative populations.
Atkin, K., Brown, B., Hussain-Gambles, M., Leese, B., Mason, S.   +4 more
core   +3 more sources

Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics

Trials, 2018
Background Large multicentre trials are complex and expensive projects. A key factor for their successful planning and delivery is how well sites meet their targets in recruiting and retaining participants, and in collecting high-quality, complete data ...
Kate F. Walker, Julie Turzanski, Diane Whitham, Alan Montgomery, Lelia Duley   +4 more
doaj   +1 more source

The Virtual International Stroke Trials Archive [PDF]

, 2007
BACKGROUND AND PURPOSE: Stroke has global importance and it causes an increasing amount of human suffering and economic burden, but its management is far from optimal. The unsuccessful outcome of several research programs highlights the need for reliable
Ali, M., Bath, P.M.W., Curram, J., Davis, S.M., Diener, H.-C., Donnan, G.A., Fisher, M., Gregson, B.A., Grotta, J., Hacke, W., Hennerici, M.G., Hommel, M., Kaste, M., Lees, K.R., Marler, J.R., Sacco, R.L., Teal, P., Wahlgren, N.-G., Warach, S., Weir, C.J.   +19 more
core   +3 more sources

Estimands in published protocols of randomised trials: urgent improvement needed

Trials, 2021
Background An estimand is a precise description of the treatment effect to be estimated from a trial (the question) and is distinct from the methods of statistical analysis (how the question is to be answered).
Brennan C. Kahan, Tim P. Morris, Ian R. White, James Carpenter, Suzie Cro   +4 more
doaj   +1 more source

Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review [PDF]

, 2005
Good quality clinical trials are essential to inform the best cystic fibrosis (CF) management and care, by determining and comparing the effectiveness of new and existing therapies and drug delivery systems.
Abbott, Janice, Hart, Anna
core   +2 more sources