De Santis, Maria
Breijo, Sara Martínez
Robinson, Paul
Capone, Camille
Pascoe, Katie
Van Sanden, Suzy
Hashim, Mahmoud
Trevisan, Marco
Daly, Caitlin
Reitsma, Friso
van Beekhuizen, Sophie
Ruan, Haoyao
Heeg, Bart
Verzoni, Elena
Funding for this research was provided by:
Cilag
Article History
Received: 11 April 2024
Accepted: 3 June 2024
First Online: 3 July 2024
Declarations
:
: Maria De Santis: received honoraria for consultancy and advisory boards by AAA, Amgen, Astellas, AstraZeneca, Basilea, Bayer, Bioclin, BMS, EISAI, Ferring, Immunomedics/Gilead, Ipsen, Janssen, MSD, Merck, Novartis, Pfizer, Orion, Roche, Sandoz, Sanofi, SeaGen Sara Martínez Breijo: provided scientific advice to Janssen, Bayer, Astellas; participated in medical meetings organized by Astellas, Astra-Zeneca, Bayer, Ipsen, Janssen, Opko, Palex and Sanofi; received payments for presentations from Astellas, Amgen, Astra-Zeneca, Bayer, Ipsen, Janssen, and Sanofi. Paul Robinson, Camille Capone, Katie Pascoe, Suzy Van Sanden, Mahmoud Hashim, and Marco Trevisan are employees of Janssen; Caitlin Daly, Friso Reitsma, Sophie van Beekhuizen, Haoyao Ruan, and Bart Heeg are employees of Cytel which was commissioned by Janssen for the study. Current affiliations: Haoyao Ruan: PhD student in the Department of Mathematics at the University of Texas at Arlington. Friso Reitsma: Senior Policy Advisor, Medicines & Medical Technology department, Dutch Ministry of Health. Elena Verzoni: served as consultant/advisory board member for Astellas, AstraZeneca, Bayer, BMS, EISAI, Ipsen, Janssen, MSD, Novartis, Pfizer.
: Data were not identifiable. Ethics committee approval was not required for this study. This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors. Aggregate-level data recorded in MAGNITUDE's clinical study reports were fully accessible to the authors and the data presented in this paper were permitted for publication by the sponsor of the trial. Aggregate-level data for all other trials were obtained from published articles identified in the publicly available MEDLINE<sup>®</sup>, MEDLINE<sup>®</sup> In-Process, and ClinicalTrials.gov databases, as well as the Embase, Cochrane Database of Systematic Reviews, and Cochrane Collaboration Central Register of Clinical Trials via Ovid.com databases which are available through a subscription. In addition, aggregate-level data were also sourced from reports published by health technology assessment agencies which are publicly available.