AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter

Autor: Gareth O. Griffiths, Richard FitzGerald, Thomas Jaki, Andrea Corkhill, Helen Reynolds, Sean Ewings, Susannah Condie, Emma Tilt, Lucy Johnson, Mike Radford, Catherine Simpson, Geoffrey Saunders, Sara Yeats, Pavel Mozgunov, Olana Tansley-Hancock, Karen Martin, Nichola Downs, Izabela Eberhart, Jonathan W. B. Martin, Cristiana Goncalves, Anna Song, Tom Fletcher, Kelly Byrne, David G. Lalloo, Andrew Owen, Michael Jacobs, Lauren Walker, Rebecca Lyon, Christie Woods, Jennifer Gibney, Justin Chiong, Nomathemba Chandiwana, Shevin Jacob, Mohammed Lamorde, Catherine Orrell, Munir Pirmohamed, Saye Khoo, on behalf of the AGILE investigators

Publikováno v: Trials, Vol 22, Iss 1, Pp 1-5 (2021)

Abstract Background There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repurposed) drugs both in

Externí odkaz: https://doaj.org/article/24657c03deb0425d9ec6d713b1197217

Prior elicitation of the efficacy and tolerability of Methotrexate and Mycophenolate Mofetil in Juvenile Localised Scleroderma [version 1; peer review: 2 approved]

Autor: Thomas Jaki, Yasin Desai, Thomas Burnett, Michael W Beresford, Heidi Jacobe, Despina Eleftheriou, Suzanne Li, Valentina Leone, Athimalaipet V Ramanan, Pavel Mozgunov, Marina E Anderson, Kathryn S Torok, Tadej Avcin, Jordi Anton, Ivan Foeldvari, Jessie Felton, Flora McErlane, Bisola Laguda, Francesco Zulian, Lindsay Shaw, Clare E Pain

Publikováno v: AMRC Open Research, Vol 3 (2021)

Background Evidence is lacking for safe and effective treatments for juvenile localised scleroderma (JLS). Methotrexate (MTX) is commonly used first line and mycophenolate mofetil (MMF) second line, despite a limited evidence base. A head to head tri

Externí odkaz: https://doaj.org/article/7b83534093a34529af0e5f6825761c33

A benchmark for dose-finding studies with unknown ordering

Autor: Thomas Jaki, Xavier Paoletti, Pavel Mozgunov

Publikováno v: Biostatistics (Oxford, England)
Biostatistics (Oxford, England), 2022, 23 (3), pp.721-737. ⟨10.1093/biostatistics/kxaa054⟩

Summary An important tool to evaluate the performance of a dose-finding design is the nonparametric optimal benchmark that provides an upper bound on the performance of a design under a given scenario. A fundamental assumption of the benchmark is tha

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::224ecfaf877864d035cdf97880e973ec
https://www.repository.cam.ac.uk/handle/1810/341666

Molnupiravir versus placebo in unvaccinated and vaccinated patients with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, placebo-controlled, double-blind, phase 2 trial

Autor: Saye H Khoo, Richard FitzGerald, Geoffrey Saunders, Calley Middleton, Shazaad Ahmad, Christopher J Edwards, Dennis Hadjiyiannakis, Lauren Walker, Rebecca Lyon, Victoria Shaw, Pavel Mozgunov, Jimstan Periselneris, Christie Woods, Katie Bullock, Colin Hale, Helen Reynolds, Nichola Downs, Sean Ewings, Amanda Buadi, David Cameron, Thomas Edwards, Emma Knox, I'ah Donovan-Banfield, William Greenhalf, Justin Chiong, Lara Lavelle-Langham, Michael Jacobs, Josh Northey, Wendy Painter, Wayne Holman, David G Lalloo, Michelle Tetlow, Julian A Hiscox, Thomas Jaki, Thomas Fletcher, Gareth Griffiths, Nicholas Paton, Fred Hayden, Janet Darbyshire, Amy Lucas, Ulrika Lorch, Andrew Freedman, Richard Knight, Stevan Julious, Rachel Byrne, Ana Cubas Atienzar, Jayne Jones, Chris Williams, Anna Song, Jan Dixon, Anja Alexandersson, Parys Hatchard, Emma Tilt, Andrew Titman, Ale Doce Carracedo, Vatsi Chandran Gorner, Andrea Davies, Louis Woodhouse, Nicola Carlucci, Emmanuel Okenyi, Marcin Bula, Kate Dodd, Jennifer Gibney, Lesley Dry, Zalina Rashid Gardner, Amin Sammour, Christine Cole, Tim Rowland, Maria Tsakiroglu, Vincent Yip, Rostam Osanlou, Anna Stewart, Ben Parker, Tolga Turgut, Afshan Ahmed, Kay Starkey, Sujamole Subin, Jennifer Stockdale, Lisa Herring, Jonathon Baker, Abigail Oliver, Mihaela Pacurar, Dan Owens, Alistair Munro, Gavin Babbage, Saul Faust, Matthew Harvey, Danny Pratt, Deepak Nagra, Aashish Vyas

Background: the antiviral drug molnupiravir was licensed for treating at-risk patients with COVID-19 on the basis of data from unvaccinated adults. We aimed to evaluate the safety and virological efficacy of molnupiravir in vaccinated and unvaccinate

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::06e70d9e57376aff40b8667277b718e2
https://eprints.soton.ac.uk/472664/

A surface-free design for phase I dual-agent combination trials

Autor: Pavel Mozgunov, Thomas Jaki, Mauro Gasparini

Publikováno v: Stat Methods Med Res

In oncology, there is a growing number of therapies given in combination. Recently, several dose-finding designs for Phase I dose-escalation trials for combinations were proposed. The majority of novel designs use a pre-specified parametric model res

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::62063e4ee0334ec9b221f583e9262b09