Considerations when planning and conducting large global observational studies: Experience from the DISCOVER study of patients with type 2 diabetes.

DISCOVER is a global programme of observational research that includes patients with type 2 diabetes initiating second-line glucose-lowering therapy from 38 countries worldwide, including many with little or no previous epidemiological data available. More than 15,000 patients were followed-up for 3 years, and comprehensive data were collected using a standardized electronic case report form at enrolment, and 6, 12, 24 and 36 months. The study has formed the basis for a long-term registry that is intended to expand the geographic and clinical scope of the study and allow data collection beyond 3 years. In this review, critical aspects of study planning and implementation are summarized, along with challenges that were faced, to provide a resource for researchers planning similar studies. In particular, it is essential to set realistic expectations regarding the degree of study representativeness that can be achieved, allow for sufficient time to obtain ethics committee approval, develop tools to help recruit patients effectively, ensure that data collection systems are robust, user-friendly and adaptable, plan adequate remote and on-site monitoring, maximize patient retention through continuous engagement with study sites and ensure that everyone involved in the study forms a friendly and effective team. Observational studies such as DISCOVER are crucial for understanding disease epidemiology and management in real-world settings. They are also increasingly used by governmental, regulatory and payor agencies for post-marketing surveillance and when considering new drug submissions. The development of future studies of similar scope and ambition to DISCOVER is encouraged.

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Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Pernilla Aarskog reports financial support was provided by AstraZeneca. Javier Cid-Ruzafa reports a relationship with Evidera that includes: employment. Stephen Sweet reports a relationship with Oxford PharmaGenesis Ltd that includes: employment. Linong Ji reports a relationship with Bayer AG that includes: consulting or advisory. Linong Ji reports a relationship with Boehringer Ingelheim that includes: consulting or advisory. Linong Ji reports a relationship with Bristol-Myers Squibb that includes: consulting or advisory and funding grants. Linong Ji reports a relationship with Eli Lilly that includes: consulting or advisory. Linong Ji reports a relationship with Merck Sharp & Dohme that includes: consulting or advisory and funding grants. Linong Ji reports a relationship with Novartis that includes: consulting or advisory and funding grants. Linong Ji reports a relationship with Novo Nordisk that includes: consulting or advisory. Linong Ji reports a relationship with Roche that includes: consulting or advisory and funding grants. Linong Ji reports a relationship with Sanofi that includes: consulting or advisory and funding grants. Linong Ji reports a relationship with Takeda that includes: consulting or advisory. Kamlesh Khunti reports a relationship with Bayer that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with Berlin-Chemie AG that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with Boehringer Ingelheim that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with Eli Lilly that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with Janssen that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with Merck Sharp & Dohme that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with Napp that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with Novartis that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with Novo Nordisk that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with Sanofi that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kamlesh Khunti reports a relationship with NIHR applied research collaboration East Midlands that includes: funding grants. Kamlesh Khunti reports a relationship with NIHR Leicester Biomedical Research Centre that includes: funding grants. Linong Jik and Kamlesh Khunti are members of the DISCOVER Scientific Committee.