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

Autor: 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

Publikováno v: Trials, Vol 20, Iss 1, Pp 1-13 (2019)

Abstract 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 clin

Externí odkaz: https://doaj.org/article/6e07272452b74f78bf38922ab9f8d1a4

Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol

Autor: Gerhardt Attard, Laura Murphy, Noel W Clarke, William Cross, Robert J Jones, Christopher C Parker, Silke Gillessen, Adrian Cook, Chris Brawley, Claire L Amos, Nafisah Atako, Cheryl Pugh, Michelle Buckner, Simon Chowdhury, Zafar Malik, J Martin Russell, Clare Gilson, Hannah Rush, Jo Bowen, Anna Lydon, Ian Pedley, Joe M O'Sullivan, Alison Birtle, Joanna Gale, Narayanan Srihari, Carys Thomas, Jacob Tanguay, John Wagstaff, Prantik Das, Emma Gray, Mymoona Alzoueb, Omi Parikh, Angus Robinson, Isabel Syndikus, James Wylie, Anjali Zarkar, George Thalmann, Johann S de Bono, David P Dearnaley, Malcolm D Mason, Duncan Gilbert, Ruth E Langley, Robin Millman, David Matheson, Matthew R Sydes, Louise C Brown, Mahesh K B Parmar, Nicholas D James, Elin Jones, Katherine Hyde, Hilary Glen, Sarah Needleman, Ursula McGovern, Denise Sheehan, Sangeeta Paisey, Richard Shaffer, Mark Beresford, Emilio Porfiri, David Fackrell, Ling Lee, Thiagarajan Sreenivasan, Sue Brock, Simon Brown, Amit Bahl, Mike Smith-Howell, Cathryn Woodward, Mau-Don Phan, Danish Mazhar, Krishna Narahari, Fiona Douglas, Anil Kumar, Abdel Hamid, Azman Ibrahim, Dakshinamoorthy Muthukumar, Matthew Simms, Jane Worlding, Anna Tran, Mohammed Kagzi, Carmel Pezaro, Virgil Sivoglo, Benjamin Masters, Pek Keng-Koh, Caroline Manetta, Duncan McLaren, Nishi Gupta, Stergios Boussios, Henry Taylor, John Graham, Carla Perna, Lucinda Melcher, Warren Grant, Ami Sabharwal, Uschi Hofmann, Robert Dealey, Neil McPhail, Robert Brierly, Lisa Capaldi, Norma Sidek, Peter Whelan, Peter Robson, Alison Falconer, Sarah Rudman, Sindu Vivekanandan, Vinod Mullessey, Maria Vilarino-Varela, Vincent Khoo, Karen Tipples, Mehran Afshar, Patryk Brulinski, Vijay Sangar, Clive Peedell, Ashraf Azzabi, Peter Hoskin, Viwod Mullassery, Santhanam Sundar, Yakhub Khan, Ruth Conroy, Andrew Protheroe, Judith Carser, Paul Rogers, Kathryn Tarver, Stephanie Gibbs, Mohammad Muneeb Khan, Mohan Hingorani, Simon Crabb, Manal Alameddine, Neeraj Bhalla, Robert Hughes, John Logue, Darren Leaning, Salil Vengalil, Daniel Ford, Georgina Walker, Ahmed Shaheen, Omar Khan, Andrew Chan, Imtiaz Ahmed, Serena Hilman, Ian Sayers, Ashok Nikapota, David Bloomfield, Tim Porter, Joji Joseph, Cyrill Rentsch, Ricardo Pereira Mestre, Enrico Roggero, Jörg Beyer, Markus Borner, Raeto Strebel, Dominik Berthold, Daniel Engeler, Hubert John, Razvan Popescu, Donat Durr

Publikováno v: Attard, Gerhardt; Murphy, Laura; Clarke, Noel W; Cross, William; Jones, Robert J; Parker, Christopher C; Gillessen, Silke; Cook, Adrian; Brawley, Chris; Amos, Claire L; Atako, Nafisah; Pugh, Cheryl; Buckner, Michelle; Chowdhury, Simon; Malik, Zafar; Russell, J Martin; Gilson, Clare; Rush, Hannah; Bowen, Jo; Lydon, Anna; ... (2022). Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. The lancet, 399(10323), pp. 447-460. Elsevier 10.1016/S0140-6736(21)02437-5
Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators 2022, ' Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol ', Lancet (London, England), vol. 399, no. 10323, pp. 447-460 . https://doi.org/10.1016/S0140-6736(21)02437-5

BACKGROUND Men with high-risk non-metastatic prostate cancer are treated with androgen-deprivation therapy (ADT) for 3 years, often combined with radiotherapy. We analysed new data from two randomised controlled phase 3 trials done in a multiarm, mul

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d07768ca840f38b8ba6462bcfaa787f1