Gaining trust through transparency: the EMERGENT-2 trial – Authors' reply
Authors: Inder Kaul, Alan Breier, Andrew C Miller, Steven M Paul, Stephen K Brannan
Journal: The Lancet (2024)

We agree with Matthew J Lennon and Gin S Malhi that transparency and scrutiny of clinical trial data, especially of novel medications before market authorisation, is important. We fully appreciate the importance of ensuring accessibility to clinical trial data for fostering trust and advancing medical science. We remind the authors that all the EMERGENT-21Kaul I Sawchak S Correll CU et al.Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline–trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial.Lancet. 2024; 403: 160-170Summary Full Text Full Text PDF PubMed Scopus (18) Google Scholar clinical trial data will be thoroughly scrutinised by regulatory bodies such as the US Food and Drug Administration and other regulatory authorities worldwide before marketing authorisation Moreover, Bristol Myers Squibb has a long-standing commitment to responsible clinical trial data sharing. Bristol Myers Squibb adheres to the joint European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America's Principles for Responsible Clinical Trial Data Sharing,2European Federation of Pharmaceutical IndustriesAssociations and Pharmaceutical Research and Manufacturers of AmericaPrinciples for responsible clinical trial data sharing.https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Report-PDFs/P-R/PhRMAEFPIAPrinciplesForResponsibleDataSharing2023.pdfDate: 2023Date accessed: June 24, 2024Google Scholar which are widely recognised as industry standards for data transparency and dissemination. These principles underscore the importance of sharing data upon request from qualified scientific and medical researchers, particularly for medicines and indications approved in the USA and the EU to facilitate legitimate research endeavours. Our commitment to transparency is not only aligned with industry standards but also prioritises the protection of patient privacy and the integrity of national regulatory systems. Bristol Myers Squibb's criteria and process for data sharing are transparent and publicly available, ensuring that requesters are qualified researchers with legitimate scientific objectives for requesting clinical trial data about patients and for medicines approved by national regulatory systems. Moreover, we take great care to uphold patient privacy by implementing adequate protections consistent with informed consent protocols. Additional information on the Principles for Responsible Clinical Trial Data Sharing,2European Federation of Pharmaceutical IndustriesAssociations and Pharmaceutical Research and Manufacturers of AmericaPrinciples for responsible clinical trial data sharing.https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Refresh/Report-PDFs/P-R/PhRMAEFPIAPrinciplesForResponsibleDataSharing2023.pdfDate: 2023Date accessed: June 24, 2024Google Scholar our commitment to clinical trial disclosure,3Bristol Myers SquibbDisclosure commitment.https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.htmlDate accessed: June 24, 2024Google Scholar and the platform for requesting data4VivliBristol Myers Squibb.https://vivli.org/ourmember/bristol-myers-squibb/Date accessed: June 24, 2024Google Scholar can be found online. We invite any further enquiries or requests for information regarding our data sharing practices and remain committed to fostering transparency and trust within the scientific community. Thank you for raising this important issue, and we look forward to continued collaboration in advancing medical research. AB has been a consultant, adviser, or both consultant and adviser for Bristol Myers Squibb, Neumarker, and Terrain Bioscience. SMP is in a leadership or fiduciary role for Rapport Therapeutics, Seaport Therapeutics, and Flare Therapeutics; has served on the Scientific Advisory Board for Rapport Therapeutics; has previously held a leadership or fiduciary role for Sage Therapeutics and Karuna Therapeutics, Bristol Myers Squibb companies; held stock or stock options in Rapport Therapeutics, Seaport Therapeutics, and Sage Therapeutics and Karuna Therapeutics, both Bristol Myers Squibb companies; and is a former employee of Karuna Therapeutics, a Bristol Myers Squibb company. ACM held grants or contracts, had patents issued, held stock or stock options, and is a former employee of Karuna Therapeutics, a Bristol Myers Squibb company; and is a consultant to Bristol Myers Squibb. SKB was a former employee of and held stock or stock options in Karuna Therapeutics, a Bristol Myers Squibb company; and is a consultant and received support for attending meetings from Bristol Myers Squibb. IK is an employee of Bristol Myers Squibb. Gaining trust through transparency: the EMERGENT-2 trialEfficacy and safety of the muscarinic receptor agonist KarXT (xanomeline–trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial