Document is current

Article History

Accepted: 13 April 2026

First Online: 6 June 2026

Declarations

:

: All authors have no funding sources for this work and no conflicting relationships that existed at any time during the conduct/development of the work. DL was employed by Lane Clark and Peacock (LCP) LLP UK, during the preparation of this manuscript after the project was completed. DL is currently employed by PHARMO, part of Lumanity, UK and is Director of PEPI Consultancy Limited and has received funds from AstraZeneca Ltd, Ariello SRO and Annexon Biosciences Inc. DP, EE, AS and SS are full-time employees of IQVIA Ltd. DR is an employee of GSK and has stock options. YM is president of YolaRx Consultants. TDK is an employee at Daiichi Sankyo, Inc and receives stock incentives. JRA is currently salaried employee at University Medical Center Utrecht, which receives institutional research funding from pharmaceutical companies and regulatory agencies, administered by University Medical Center Utrecht. All these studies follow the ENCePP code of conduct. SAO is an employee of Thermo Fisher Scientific. AP is Managing Director of Shella Consulting Ltd.

: Not applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: DL and AP contributed to the conceptualisation of the project, methodology, project administration, focus group discussions, and manuscript preparation. DP contributed to the conceptualisation of project, methodology, literature review, focus group discussions and manuscript preparation. DR, YM, TDK and SAO contributed to the conceptualisation of the project, methodology, focus group discussions and manuscript preparation. AS contributed expertise and comments related to Data Quality Frameworks. JRA and EE contributed to the methodology, interpretation of data, and critical review of the manuscript and group discussions. SS contributed to the methodology approach, literature review and manuscript preparation. All authors reviewed and commented on the manuscript at all stages of development, and all agree to be accountable for this work.