Results 11 to 20 of about 2,053,087 (266)

Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK

Trials, 2021
Background Eligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants’ safety ...
William J. Cragg, Kathryn McMahon, Jamie B. Oughton, Rachel Sigsworth, Christopher Taylor, Vicky Napp   +5 more
doaj   +1 more source

Implications of analysing time-to-event outcomes as binary in meta-analysis: empirical evidence from the Cochrane Database of Systematic Reviews

BMC Medical Research Methodology, 2022
Background Systematic reviews and meta-analysis of time-to-event outcomes are frequently published within the Cochrane Database of Systematic Reviews (CDSR). However, these outcomes are handled differently across meta-analyses.
Theodosia Salika, Rebecca M. Turner, David Fisher, Jayne F. Tierney, Ian R. White   +4 more
doaj   +1 more source

Handling an uncertain control group event risk in non-inferiority trials: non-inferiority frontiers and the power-stabilising transformation

Trials, 2020
Background Non-inferiority trials are increasingly used to evaluate new treatments that are expected to have secondary advantages over standard of care, but similar efficacy on the primary outcome.
Matteo Quartagno, A. Sarah Walker, Abdel G. Babiker, Rebecca M. Turner, Mahesh K. B. Parmar, Andrew Copas, Ian R. White   +6 more
doaj   +1 more source

A patient-reported pressure ulcer health-related quality of life instrument for use in prevention trials (PU-QOL-P): psychometric evaluation

Health and Quality of Life Outcomes, 2018
Introduction Pressure ulcer-specific patient-reported outcome (PRO) instruments should be used to inform patient care and provide a strong evidence base for interventions aimed at preventing pressure ulcers.
Claudia Rutherford, Julia M. Brown, Isabelle Smith, Elizabeth McGinnis, Lyn Wilson, Rachael Gilberts, Sarah Brown, Susanne Coleman, Howard Collier, Jane Nixon   +9 more
doaj   +1 more source

The Smooth Away From Expected (SAFE) non-inferiority frontier: theory and implementation with an application to the D3 trial

Trials, 2023
Background In a non-inferiority trial, the choice of margin depends on the expected control event risk. If the true risk differs from expected, power and interpretability of results can be affected. A non-inferiority frontier pre-specifies an appropriate
Matteo Quartagno, Man Chan, Anna Turkova, Deborah Ford, Ian R. White   +4 more
doaj   +1 more source

Efficacy and safety of the RTS,S/AS01 malaria vaccine during 18 months after vaccination: a phase 3 randomized, controlled trial in children and young infants at 11 African sites.

PLoS Medicine, 2014
BackgroundA malaria vaccine could be an important addition to current control strategies. We report the safety and vaccine efficacy (VE) of the RTS,S/AS01 vaccine during 18 mo following vaccination at 11 African sites with varying malaria transmission ...
RTS,S Clinical Trials Partnership
doaj   +1 more source

Duplicated network meta-analysis in advanced prostate cancer: a case study and recommendations for change

Systematic Reviews, 2022
Background Research overlap and duplication is a recognised problem in the context of both pairwise and network systematic reviews and meta-analyses.
David J. Fisher, Sarah Burdett, Claire Vale, Ian R. White, Jayne F. Tierney   +4 more
doaj   +1 more source

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

Digital Biomarkers, 2023
Introduction: Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited ...
Brian Perry, Lindsay Kehoe, Teresa Swezey, Quentin Le Masne, Jörg Goldhahn, Alicia Staley, Amy Corneli   +6 more
doaj   +1 more source

Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons

Trials, 2019
Background There is limited research and literature on the data management challenges encountered in multi-arm, multi-stage platform and umbrella protocols.
Dominic Hague, Stephen Townsend, Lindsey Masters, Mary Rauchenberger, Nadine Van Looy, Carlos Diaz-Montana, Melissa Gannon, Nicholas James, Tim Maughan, Mahesh K. B. Parmar, Louise Brown, Matthew R. Sydes, for the STAMPEDE and FOCUS4 investigators   +12 more
doaj   +1 more source

Use of vitamins by participants in amyotrophic lateral sclerosis clinical trials.

PLoS ONE, 2020
Patients' vitamin intake is often not documented and is therefore not considered sufficiently in studies of prescribed medication in patients with amyotrophic lateral sclerosis (ALS). We aimed to determine the prevalence of vitamin use by participants in
Tino Prell, Julian Grosskreutz, Pooled Resource Open-Access ALS Clinical Trials Consortium   +2 more
doaj   +1 more source