Re: Final Report of the Intergroup Randomized Study of Combined AndrogenDeprivation Therapy Plus Radiotherapy Versus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate... by Malcolm D. Mason, Wendy R. Parulekar, Matthew R. Sydes

Get full text

Monitoring in practice – How are UK academic clinical trials monitored? A survey by Sharon B. Love, Victoria Yorke-Edwards, Sarah Lensen, Matthew R. Sydes

Get full text

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial by Elizabeth C. James, David Dunn, Adrian D. Cook, Andrew R. Clamp, Matthew R. Sydes

Get full text

Prospective reporting of statistical analysis plans for randomised controlled trials by Karla Hemming, Anna Kearney, Carrol Gamble, Tianjing Li, Peter Jüni, An-Wen Chan, Matthew R. Sydes

Get full text

Implementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system by Carlos Diaz-Montana, William J. Cragg, Rahela Choudhury, Nicola Joffe, Matthew R. Sydes, Sally P. Stenning

Get full text

Data sharing and the evolving role of statisticians by Nick Manamley, Steve Mallett, Matthew R. Sydes, Sally Hollis, Alison Scrimgeour, Hans Ulrich Burger, Hans-Joerg Urban

Get full text

Use of routinely collected health data in randomised clinical trials: comparison of trial-specific death data in the BOSS trial with NHS Digital data by Sharon B. Love, Anna Kilanowski, Victoria Yorke-Edwards, Oliver Old, Hugh Barr, Clive Stokes, Catherine Kendall, Matthew R. Sydes

Get full text

Reporting guidelines for clinical trials of artificial intelligence interventions: the SPIRIT-AI and CONSORT-AI guidelines by Hussein Ibrahim, Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, An-Wen Chan, Matthew R. Sydes, Melanie J. Calvert, Alastair K. Denniston

Get full text

Mind the gap? The platform trial as a working environment by Liz Morrell, Joshua Hordern, Louise Brown, Matthew R. Sydes, Claire L. Amos, Richard S. Kaplan, Mahesh K. B. Parmar, Timothy S. Maughan

Get full text

A DELPHI study priority setting the remaining challenges for the use of routinely collected data in trials: COMORANT-UK by Adam D. N. Williams, Gwyneth Davies, Amanda J. Farrin, Marion Mafham, Michael Robling, Matthew R. Sydes, Fiona V. Lugg-Widger

Get full text

Adaptive platform trials using multi-arm, multi-stage protocols: getting fast answers in pandemic settings [version 1; peer review: 2 approved] by Nurulamin M. Noor, Sarah L. Pett, Hanif Esmail, Angela M. Crook, Claire L. Vale, Matthew R. Sydes, Mahesh K.B. Parmar

Get full text

Adaptive platform trials using multi-arm, multi-stage protocols: getting fast answers in pandemic settings [version 2; peer review: 2 approved] by Nurulamin M. Noor, Sarah L. Pett, Hanif Esmail, Angela M. Crook, Claire L. Vale, Matthew R. Sydes, Mahesh K.B. Parmar

Get full text

A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials by Elizabeth J. Conroy, Barbara Arch, Nicola L. Harman, J. Athene Lane, Steff C. Lewis, John Norrie, Matthew R. Sydes, Carrol Gamble

Get full text

‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact by Anne Daykin, Lucy E. Selman, Helen Cramer, Sharon McCann, Gillian W. Shorter, Matthew R. Sydes, Carrol Gamble, Rhiannon Macefield, J. Athene Lane, Alison Shaw

Get full text

Access to routinely collected health data for clinical trials – review of successful data requests to UK registries by Sarah Lensen, Archie Macnair, Sharon B. Love, Victoria Yorke-Edwards, Nurulamin M. Noor, Meredith Martyn, Alexandra Blenkinsop, Carlos Diaz-Montana, Graham Powell, Elizabeth Williamson, James Carpenter, Matthew R. Sydes

Get full text

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

Get full text

Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial. by Annabelle South, Nalinie Joharatnam-Hogan, Cara Purvis, Elizabeth C James, Carlos Diaz-Montana, William J Cragg, Conor Tweed, Archie Macnair, Matthew R Sydes, Claire Snowdon, Katie Gillies, Talia Isaacs, Barbara E Bierer, Andrew J Copas

Get full text

Correction: Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Re... by Martin Law, Dominique-Laurent Couturier, Babak Choodari-Oskooei, Phillip Crout, Carrol Gamble, Peter Jacko, Philip Pallmann, Mark Pilling, David S. Robertson, Michael Robling, Matthew R. Sydes, Sofía S. Villar, James Wason, Graham Wheeler, S. Faye Williamson, Christina Yap, Thomas Jaki

Get full text

Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partn... by Martin Law, Dominique-Laurent Couturier, Babak Choodari-Oskooei, Phillip Crout, Carrol Gamble, Peter Jacko, Philip Pallmann, Mark Pilling, David S. Robertson, Michael Robling, Matthew R. Sydes, Sofía S. Villar, James Wason, Graham Wheeler, S. Faye Williamson, Christina Yap, Thomas Jaki

Get full text

Adaptive designs in clinical trials: why use them, and how to run and report them by Philip Pallmann, Alun W. Bedding, Babak Choodari-Oskooei, Munyaradzi Dimairo, Laura Flight, Lisa V. Hampson, Jane Holmes, Adrian P. Mander, Lang’o Odondi, Matthew R. Sydes, Sofía S. Villar, James M. S. Wason, Christopher J. Weir, Graham M. Wheeler, Christina Yap, Thomas Jaki

Get full text