Results 21 to 30 of about 2,053,087 (266)

Treatment estimands in clinical trials of patients hospitalised for COVID-19: ensuring trials ask the right questions

BMC Medicine, 2020
When designing a clinical trial, explicitly defining the treatment estimands of interest (that which is to be estimated) can help to clarify trial objectives and ensure the questions being addressed by the trial are clinically meaningful.
Brennan C. Kahan, Tim P. Morris, Ian R. White, Conor D. Tweed, Suzie Cro, Darren Dahly, Tra My Pham, Hanif Esmail, Abdel Babiker, James R. Carpenter   +9 more
doaj   +1 more source

Accessing routinely collected health data to improve clinical trials: recent experience of access

Trials, 2021
Background Routinely collected electronic health records (EHRs) have the potential to enhance randomised controlled trials (RCTs) by facilitating recruitment and follow-up.
Archie Macnair, Sharon B. Love, Macey L. Murray, Duncan C. Gilbert, Mahesh K. B. Parmar, Tom Denwood, James Carpenter, Matthew R. Sydes, Ruth E. Langley, Fay H. Cafferty   +9 more
doaj   +1 more source

Clinical Trial Results: A Clinical Trial Bazaar! [PDF]

The Oncologist, 2014
The Oncologist's Clinical Trial Results section welcomes both positive and negative results in an effort to share information, speed discovery, and inform the field. Clinical Trial Results submissions have shown how succinctly the salient features of a submission can be presented, with more in-depth information to be found online.
Antonio Tito, Fojo, Susan E, Bates
openaire   +2 more sources

This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols

Trials, 2019
Background There are limited research and literature on the trial management challenges encountered in running adaptive platform trials. This trial design allows both (1) the seamless addition of new research comparisons when compelling clinical and ...
Francesca Schiavone, Riya Bathia, Krishna Letchemanan, Lindsey Masters, Claire Amos, Anna Bara, Louise Brown, Clare Gilson, Cheryl Pugh, Nafisah Atako, Fleur Hudson, Mahesh Parmar, Ruth Langley, Richard S. Kaplan, Chris Parker, Gert Attard, Noel W. Clarke, Silke Gillessen, Nicholas D. James, Tim Maughan, Matthew R. Sydes, On behalf of past and present members of the STAMPEDE and FOCUS4 Trial Management Group   +21 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

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

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

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

European Standard Clinical Practice Guideline and EXPeRT Recommendations for the Diagnosis and Management of Gastroenteropancreatic Neuroendocrine Neoplasms in Children and Adolescents

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Pediatric gastroenteropancreatic neuroendocrine neoplasms (GEP‐NENs) are extremely rare and clinically heterogeneous. Management has largely been extrapolated from adult practice. This European Standard Clinical Practice Guideline (ESCP), developed by the EXPeRT network in collaboration with adult NEN experts, provides (adult) evidence ...
Michaela Kuhlen, Calogero Virgone, Antje Redlich, Michael Abele, Ricardo Lopez‐Almaraz, Tal Ben‐Ami, Ewa Bien, Gianni Bisogno, Maja Mazic Cesen, Andrea Ferrari, Malgorzata A. Krawczyk, Yves Reguerre, Dominik T. Schneider, Ines B. Brecht, Charlotte Rigaud, Bilgehan Yalcin, Rainer Claus, Christian Vokuhl, Constantin Lapa, Jörg Fuchs, Segolene Hescot, Thomas Walter, Julien Hadoux, Daniel Orbach   +23 more
wiley   +1 more source

A phase I/II randomized controlled clinical trial to assess the feasibility, safety, and preliminary effectiveness of paracetamol in resolving acute kidney injury in children with severe malaria

Trials
Background Acute kidney injury (AKI) is prevalent among children with severe malaria, contributing to considerable morbidity and mortality. Oxidative stress has been implicated in the pathophysiology of malaria-induced AKI, and paracetamol, with its ...
George Paasi, Cate Namayanja, Paul Ongodia, Charles Benard Okalebo, William Okiror, Grace Abongo, George Masifa, Denis Amorut, Rita Muhindo, Peter Olupot-Olupot, the PARIST trial study group   +10 more
doaj   +1 more source