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

Autor: 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

Publikováno v: Trials, Vol 20, Iss 1, Pp 1-16 (2019)

Abstract Background There is limited research and literature on the data management challenges encountered in multi-arm, multi-stage platform and umbrella protocols. These trial designs allow both (1) seamless addition of new research comparisons and

Externí odkaz: https://doaj.org/article/dbb0614eb01644b1b2c22551595797c6

Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial

Autor: Ruth L Goodall, Sarah K Meredith, Andrew J Nunn, Adamu Bayissa, Anuj K Bhatnagar, Gay Bronson, Chen-Yuan Chiang, Francesca Conradie, Meera Gurumurthy, Bruce Kirenga, Nana Kiria, Daniel Meressa, Ronelle Moodliar, Gopalan Narendran, Nosipho Ngubane, Mohammed Rassool, Karen Sanders, Rajesh Solanki, S Bertel Squire, Gabriela Torrea, Bazarragchaa Tsogt, Elena Tudor, Armand Van Deun, I D Rusen, Oyunchimeg Adilaa, Sofia Alexandru, Katharine Bellenger, Jaclyn Bennet, Deborah Bennet, Priyanka Bindroo, Ghanshyam Borisagar, Claire Cook, Doljinsuren Dalai, Andrew Davis, Bouke de Jong, Wendy Dodds, Lynette Duckworth, Nonhlanhla Gahima, Belay Gebreegziabher, Anne Goldfeld, Mahmud Hanifa, Gareth Hughes, Ivan Kimuli, Jan Komrska, Nino Lomtadze, Brendan Murphy, Thando Mwelase, Joanitah Nalunjogi, Leena Patel, Irina Pirlog, Ishmael Qawiy, Mary Rauchenberger, Leen Rigouts, Carol Roach, Laura Rosu, Ezio Santos-Filho, Thirumaran Senguttuvan, Million Sisay, Rathinam Sridhar, Vignes Srinivasulu, Mekonnen Teferi, Helen Teklu, Narangarav Tsegeen, Odette van Amsterdam, Lisa White, Johanna Whitney, Chuluunbaatar Zagd

Publikováno v: Lancet (London, England). 400(10366)

The STREAM stage 1 trial showed that a 9-month regimen for the treatment of rifampicin-resistant tuberculosis was non-inferior to the 20-month 2011 WHO-recommended regimen. In STREAM stage 2, we aimed to compare two bedaquiline-containing regimens wi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c955b8f2fa408406f893ed06e640c853
https://pubmed.ncbi.nlm.nih.gov/36375483

Incoming HIV virion-derived Gag Spacer Peptide 2 (p1) is a target of effective CD8(+) T cell antiviral responses

Autor: Hongbing Yang, Anuska Llano, Samandhy Cedeño, Annette von Delft, Angelica Corcuera, Geraldine M. Gillespie, Andrew Knox, Darren B. Leneghan, John Frater, Wolfgang Stöhr, Sarah Fidler, Beatriz Mothe, Johnson Mak, Christian Brander, Nicola Ternette, Lucy Dorrell, Eric Sandström, Janet Darbyshire, Frank Post, Christopher Conlon, Jane Anderson, Mala Maini, Timothy Peto, Peter Sasieni, Veronica Miller, Ian Weller, Abdel Babiker, Sarah Pett, Matthew Pace, Natalia Olejniczak, Helen Brown, Nicola Robinson, Jakub Kopycinski, Tomáš Hanke, Alison Crook, Steven Kaye, Myra McClure, Otto Erlwein, Andrew Lovell, Maryam Khan, Michelle Gabrielle, Rachel Bennett, Aminata Sy, Adam Gregory, Fleur Hudson, Charlotte Russell, Gemma Wood, Hanna Box, Cherry Kingsley, Katie Topping, Andrew Lever, Mark Wills, Axel Fun, Mikaila Bandara, Damian Kelly, Simon Collins, Alex Markham, Mary Rauchenberger, Yinka Sowunmi, Shaadi Shidfar, Dominic Hague, Mark Nelson, Maddalena Cerrone, Nadia Castrillo Martinez, Tristan Barber, Alexandra Schoolmeesters, Christine Weaver, Orla Thunder, Jane Rowlands, Christopher Higgs, Serge Fedele, Margherita Bracchi, Lervina Thomas, Peter Bourke, Nneka Nwokolo, Gaynor Lawrenson, Marzia Fiorino, Hinal Lukha, Sabine Kinloch-de Loes, Margaret Johnson, Alice Nightingale, Nnenna Ngwu, Patrick Byrne, Zoe Cuthbertson, Martin Jones, Tina Fernandez, Amanda Clarke, Martin Fisher, Rebecca Gleig, Vittorio Trevitt, Colin Fitzpatrick, Tanya Adams, Fiounnuala Finnerty, John Thornhill, Heather Lewis, Kristin Kuldanek, Julie Fox, Julianne Lwanga, Hiromi Uzu, Ming Lee, Simon Merle, Patrick O’Rourke, Isabel Jendrulek, Taras Zarko Flynn, Mark Taylor, Juan Manuel Tiraboschi, Tammy Murray

Publikováno v: Cell Reports
r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol
instname

Persistence of HIV through integration into host DNA in CD4(+) T cells presents a major barrier to virus eradication. Viral integration may be curtailed when CD8(+) T cells are triggered to kill infected CD4(+) T cells through recognition of histocom

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e6f7b05b028eaac835e405a6ac4e7c84
https://fundanet.igtp.cat/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=2035

Retrospective evaluation of neutropenic admission events in metastatic or high-risk hormone-sensitive prostate cancer (HSPC) patients having docetaxel chemotherapy upfront or for castrate-resistant prostate cancer (CRPC) in STAMPEDE

Autor: Mary Rauchenberger, Claire Amos, H.P. Mintz, M.K.B. Parmar, Christopher D. Brawley, Helen Parsons, L. Hounsome, F.C. Ingleby, H. Wu, Prashant Patel, J. Calvert, Nicholas D. James, Matthew R. Sydes, Melissa Gannon, R. Brannan, S. McPhail

Publikováno v: Annals of Oncology. 30:v337

Background Docetaxel (Doc) was initially licenced for CRPC (TAX327) but more recently trials showed Doc at HSPC diagnosis improved survival, shifting patterns of use. Higher neutropenic toxicity rates were reported in the HSPC trials, but it is uncle

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::796685531b2492591c9ed203c8b17a52
https://doi.org/10.1093/annonc/mdz248.019

Comparing the use of traditional and agile development methodologies in a clinical trials environment

Autor: Mary Rauchenberger, Emma Little, Carlos Diaz Montana

Publikováno v: Trials

Computer systems used for clinical trials need to have documented evidence that they are validated systems. This is a formal process that assures users (and regulatory inspectors) that the system is fit for purpose. At MRC CTU, we have successfully m

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9ef9c1c24ad8ce76b19fbc83af70b555
https://doi.org/10.1186/1745-6215-14-s1-p65