Results 21 to 30 of about 6,339,362 (215)

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

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

Communication about children's clinical trials as observed and experienced: qualitative study of parents and practitioners. [PDF]

, 2011
Recruiting children to clinical trials is perceived to be challenging. To identify ways to optimise recruitment and its conduct, we compared how parents and practitioners described their experiences of recruitment to clinical ...
Shilling, V, Smyth, RL, Bridget Young (128749), Helen Hickey (166297), Paula R. Williamson, Bridget Young, Helen Hickey, Emma Sowden (214406), Valerie Shilling (4460977), Paula R Williamson, Shilling Valerie, Beresford Michael W., Valerie Shilling, Young, B, Rosalind L Smyth, Michael W Beresford, Hickey Helen, Rosalind L Smyth (16234277), Michael W Beresford (9964186), Beresford, MW, Sowden, E, Williamson Paula R., Michael W. Beresford, Emma Sowden, Smyth Rosalind L., Young Bridget, Williamson, PR, Hickey, H, Rosalind L. Smyth, Sowden Emma, Paula R Williamson (11606900), Williamson, Paula R, Shilling, Valerie, Beresford, Michael W, Young, Bridget, Hickey, Helen, Sowden, Emma, Smyth, Rosalind L   +37 more
core   +1 more source

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

Pharmacokinetic research in children: an analysis of registered records of clinical trials. [PDF]

, 2011
BACKGROUND: Reported off-label/unlicensed prescribing rates in children range from 11% to 80%. Research into pharmacokinetic profiles of children's medicines is essential in the creation of more knowledge on the safety and efficacy of medicines in ...
Rademaker, Carin MA, Viergever, Roderik F, C. M. A. Rademaker, Ghersi, Davina, D. Ghersi, R. F. Viergever   +5 more
core   +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

Marketing and clinical trials : a case study [PDF]

, 2007
Background: Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well ...
Francis, D, Francis, David, McDonald, Alison Mary, Knight, R.C, McDonald, A.M, Garcia Jo, McDonald Alison M, Francis, David; id_orcid, McDonald, Alison M, Vikki A Entwistle, Campbell, Marion K, Rosemary C Knight, Snowdon Claire, Entwistle, V.A, Campbell, Marion K., Francis David, Grant Adrian M, Knight, Rosemary C, Haleema Shakur, Entwistle Vikki A, Roberts, Ian, Entwistle, Vikki A., Elbourne, D.R, Shakur, H, Entwistle, Vikki, Mcdonald, Alison M., Campbell, Marion Kay, Snowdon, Claire, Grant, Adrian M, Garcia, J, David Francis, Diana R Elbourne, Alison M McDonald, Elbourne, Diana R., Roberts Ian, Shakur, Haleema, Elbourne, Diana R, Grant, Adrian Maxwell, Campbell Marion K, Entwistle, Vikki A, Snowdon, C, Campbell, M.K, Shakur Haleema, Grant, Adrian M., Knight, Rosemary C., Garcia, Jo, Adrian M Grant, Ian Roberts, Claire Snowdon, Grant, A.M, Marion K Campbell, Knight Rosemary C, Jo Garcia, Elbourne Diana R, Roberts, I   +54 more
core   +4 more sources

Sharing data from clinical trials: the rationale for a controlled access approach. [PDF]

, 2015
The move towards increased transparency around clinical trials is welcome. Much focus has been on under-reporting of trials and access to individual patient data to allow independent verification of findings.
Parmar, MK, Meredith, SK, Mary Rauchenberger, Matthew R Sydes, Annabelle South, Anthony L Johnson, Mahesh KB Parmar, Sydes, MR, Johnson, AL, South, A, Rauchenberger, M, Sarah K Meredith   +11 more
core   +2 more sources

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