TY - JOUR
T1 - Data and sample sharing as an enabler for large-scale biomarker research and development: The EPND perspective
AU - Bose, N.
AU - Brookes, A.J.
AU - Scordis, P.
AU - Visser, P.J.
AU - EPND Consortium
N1 - Funding Information:
The authors would like to acknowledge Angela Bradshaw, Andréa Vieira, and Leslie Weston for their contributions to the drafting of the manuscript. The authors present this perspective paper on behalf of the EPND consortium, including the work package leaders: Angela Bradshaw, Giovanni Frisoni, Rajaraman Krishnan, Rejko Krüger, Raj Long, Kristina Malzbender, Laurent Pradier, Frances-Catherine Quevenco, Johannes Streffer, Charlotte Teunissen, Adrian Thorogood, Anton Ussi, Herman Verheij, and Leslie Weston. All EPND partner organizations are listed on epnd.org.
Funding Information:
This work was supported by funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement number 101034344 (EPND). The IMI JU receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.
Publisher Copyright:
Copyright © 2022 Bose, Brookes, Scordis and Visser.
PY - 2022/11/30
Y1 - 2022/11/30
N2 - Biomarker discovery, development, and validation are reliant on large-scale analyses of high-quality samples and data. Currently, significant quantities of data and samples have been generated by European studies on Alzheimer's disease (AD) and other neurodegenerative diseases (NDD), representing a valuable resource for developing biomarkers to support early detection of disease, treatment monitoring, and patient stratification. However, discovery of, access to, and sharing of data and samples from AD and NDD research are hindered both by silos that limit collaboration, and by the array of complex requirements for secure, legal, and ethical sharing. In this Perspective article, we examine key challenges currently hampering large-scale biomarker research, and outline how the European Platform for Neurodegenerative Diseases (EPND) plans to address them. The first such challenge is a fragmented landscape filled with technical barriers that make it difficult to discover and access high-quality samples and data in one location. A second challenge is related to the complex array of legal and ethical requirements that must be navigated by researchers when sharing data and samples, to ensure compliance with data protection regulations and research ethics. Another challenge is the lack of broad-scale collaboration and opportunities to facilitate partnerships between data and sample contributors and researchers, in addition to a lack of regulatory engagement early in the research process to enable validation of potential biomarkers. A further challenge facing projects is the need to remain sustainable beyond initial funding periods, ensuring data and samples are shared and reused, thereby driving further research and innovation. In addressing these challenges, EPND will enable an environment of faster and more disruptive research on diagnostics and disease-modifying therapies for Alzheimer's disease and other neurodegenerative diseases.
AB - Biomarker discovery, development, and validation are reliant on large-scale analyses of high-quality samples and data. Currently, significant quantities of data and samples have been generated by European studies on Alzheimer's disease (AD) and other neurodegenerative diseases (NDD), representing a valuable resource for developing biomarkers to support early detection of disease, treatment monitoring, and patient stratification. However, discovery of, access to, and sharing of data and samples from AD and NDD research are hindered both by silos that limit collaboration, and by the array of complex requirements for secure, legal, and ethical sharing. In this Perspective article, we examine key challenges currently hampering large-scale biomarker research, and outline how the European Platform for Neurodegenerative Diseases (EPND) plans to address them. The first such challenge is a fragmented landscape filled with technical barriers that make it difficult to discover and access high-quality samples and data in one location. A second challenge is related to the complex array of legal and ethical requirements that must be navigated by researchers when sharing data and samples, to ensure compliance with data protection regulations and research ethics. Another challenge is the lack of broad-scale collaboration and opportunities to facilitate partnerships between data and sample contributors and researchers, in addition to a lack of regulatory engagement early in the research process to enable validation of potential biomarkers. A further challenge facing projects is the need to remain sustainable beyond initial funding periods, ensuring data and samples are shared and reused, thereby driving further research and innovation. In addressing these challenges, EPND will enable an environment of faster and more disruptive research on diagnostics and disease-modifying therapies for Alzheimer's disease and other neurodegenerative diseases.
KW - neurodegenerative disease
KW - Alzheimer's disease
KW - data-sharing
KW - sample-sharing
KW - platforms
KW - biomarker research
KW - cohort
U2 - 10.3389/fneur.2022.1031091
DO - 10.3389/fneur.2022.1031091
M3 - Article
C2 - 36530625
SN - 1664-2295
VL - 13
JO - Frontiers in Neurology
JF - Frontiers in Neurology
M1 - 1031091
ER -