Regulatory agilities impacting review timelines for Pfizer/BioNTech’s BNT162b2 mRNA COVID-19 vaccine: a retrospective study

Autor: Prisha Patel, Judith C. Macdonald, Jayanthi Boobalan, Matthew Marsden, Ruben Rizzi, Marianne Zenon, Jinma Ren, Haitao Chu, Joseph C. Cappelleri, Satrajit Roychoudhury, Julie O’Brien, Konoha Izaki-Lee, Donna Boyce

Publikováno v: Frontiers in Medicine, Vol 10 (2023)

The appropriate use of regulatory agilities has the potential to accelerate regulatory review, utilize resources more efficiently and deliver medicines and vaccines more rapidly, all without compromising quality, safety and efficacy. This was clearly

Externí odkaz: https://doaj.org/article/b5aa6ad889334a9cb58a80467a1d9aae

Bayesian hierarchical model-based network meta-analysis to overcome survival extrapolation challenges caused by data immaturity

Autor: Bart Heeg, Andre Verhoek, Gabriel Tremblay, Ofir Harari, Mohsen Soltanifar, Haitao Chu, Satrajit Roychoudhury, Joseph C Cappelleri

Publikováno v: Journal of Comparative Effectiveness Research, Vol 12, Iss 3 (2023)

Aim: This research evaluated standard Weibull mixture cure (WMC) network meta-analysis (NMA) with Bayesian hierarchical (BH)WMCNMAto inform long-term survival of therapies. Materials & methods: Four trials in previously treated metastatic non-small

Externí odkaz: https://doaj.org/article/bda791ab4a2a40429f0b41dea9350d65

Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice

Autor: Limin Liu, Jungyeon Choi, Jammbe Z Musoro, Willi Sauerbrei, Cecilie Delphin Amdal, Ahu Alanya, Yolanda Barbachano, Joseph C Cappelleri, Ragnhild Sørum Falk, Mallorie H Fiero, Antoine Regnault, Jaap C Reijneveld, Rickard Sandin, Doranne Thomassen, Satrajit Roychoudhury, Els Goetghebeur, Saskia le Cessie, Olalekan Lee Aiyegbusi, Ethan Basch, Melanie Calvert, Alicyn Campbell, Joseph Cappelleri, Samantha Cruz Rivera, Mallorie Fiero, Rajesh Kamalakar, Karen Keating, Paul Kluetz, Geert Molenberghs, Jammbe Musoro, David Ness, Khadija Rantell, Jaap Reijneveld, Gerhard Rumpold, Alexander Russell-Smith, Claudia Rutherford, Kavita Sail, Maxime Sasseville, Anja Schiel, Michael Schlichting, Kathy Soltys, Ragnhild Sorum Falk, Yun Su, Silene ten Seldam, Kelly Van Lancker

Publikováno v: Liu, L, Choi, J, Musoro, J Z, Sauerbrei, W, Amdal, C D, Alanya, A, Barbachano, Y, Cappelleri, J C, Falk, R S R, Fiero, M H, Regnault, A, Reijneveld, J C, SISAQOL-IMI Work Package 3, Sandin, R, Thomassen, D, Roychoudhury, S, Goetghebeur, E & le Cessie, S 2023, ' Single-arm studies involving patient-reported outcome data in oncology : a literature review on current practice ', The Lancet Oncology, vol. 24, no. 5, pp. e197-e206 . https://doi.org/10.1016/S1470-2045(23)00110-9

Patient-reported outcomes (PROs) are increasingly used in single-arm cancer studies. We reviewed 60 papers published between 2018 and 2021 of single-arm studies of cancer treatment with PRO data for current practice on design, analysis, reporting, an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::45e7ed9525c5e6a37dc74e0361c03e4d
https://doi.org/10.1016/s1470-2045(23)00110-9

Challenges in Implementing Futility Schemes, with Reference to Aducanumab

Autor: Paul Gallo, Satrajit Roychoudhury

Publikováno v: Therapeutic Innovation & Regulatory Science. 57:515-520

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::70d91ac4be9371c37ec7e644ac9b82f0
https://doi.org/10.1007/s43441-023-00499-0

Plain language summary of Pfizer-BioNTech BNT162b2 COVID-19 vaccine safety in participants 16 years or older and protection against COVID-19 in participants 12 years or older

Autor: Stephen J Thomas, Edson D Moreira, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L Perez, Gonzalo Pérez Marc, Fernando P Polack, Cristiano Zerbini, Ruth Bailey, Kena A Swanson, Xia Xu, Satrajit Roychoudhury, Kenneth Koury, Salim Bouguermouh, Warren V Kalina, David Cooper, Robert W Frenck, Laura L Hammitt, Özlem Türeci, Haylene Nell, Axel Schaefer, Serhat Ünal, Qi Yang, Paul Liberator, Dina B Tresnan, Susan Mather, Philip R Dormitzer, Uğur Şahin, William C Gruber, Kathrin U Jansen

Publikováno v: Future Virology. 17:849-862

What is this summary about? This is a summary of an article about part of a clinical study for the BNT162b2 COVID-19 vaccine, also called the Pfizer-BioNTech vaccine. The article was published in the New England Journal of Medicine in September 2021.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::89c8f6ff58aa5a276a94ec07939de9fa
https://doi.org/10.2217/fvl-2022-0142