TY - JOUR
T1 - Real-world evidence
T2 - new opportunities for osteoporosis research. Recommendations from a Working Group from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)
AU - Moon, Rebecca J.
AU - Reginster, Jean Yves
AU - Al-Daghri, Nasser M.
AU - Thiyagarajan, Jotheeswaran A.
AU - Beaudart, Charlotte
AU - Bruyère, Olivier
AU - Burlet, Nansa
AU - Chandran, Manju
AU - da Silva, Mario Coelho
AU - Conaghan, Philip G.
AU - Dere, Willard H.
AU - Diez-Perez, Adolfo
AU - Hadji, Peyman
AU - Halbout, Philippe
AU - Hiligsmann, Mickaël
AU - Kanis, John A.
AU - McCloskey, Eugene V.
AU - Ormarsdottir, Sif
AU - Prieto-Alhambra, Daniel
AU - Radermecker, Régis P.
AU - Rizzoli, René
AU - Al-Saleh, Yousef
AU - Silverman, Stuart L.
AU - Simon, Lee S.
AU - Thomasius, Friederike
AU - van Staa, Tjeerd
AU - Laslop, Andrea
AU - Cooper, Cyrus
AU - Harvey, Nicholas C.
N1 - Funding Information:
RJM has received travel bursaries from Kyowa Kirin. OB has received consulting or lecture fees from Amgen, Aptissen, Biophytis, IBSA, Mylan, Novartis, Orifarm, Sanofi, UCB and Viatris. MC has received honoraria for speaking and chairing engagements from AMGEN, DKSH and Kyowa Kirin. PGC has received speakers bureaus or consultancies from AbbVie, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Galapagos, GlaxoSmithKline, Grunenthal, Merck, Novartis, Pfizer, Stryker and UCB, outside the submitted work. WHD is on the board of Directors for BioMarin, Seres, Mersana and Metagenomi, Chief Advisor to CEO at Angitia and is a former employee and shareholder at Eli Lilly and Amgen. MH has research grants paid to his institution from Amgen, Radius Health, and consulting fees from UCB. EVM reports research support and/or personal fees from Amgen, Eli Lilly, Fresenius Kabi, ObsEva and UCB, outside the submitted work. SO has received consultancy fees from Merck and Pfizer not related to the current work or therapeutic field. RR has speaker bureau or advisory board for Abiogen, Naturex, Nestlé and ObsEva. YAS reports lecture honoraria from Amgen, Eli Lilly and SAJA. SLS has acted as a consultant for Radius and Amgen, received funding from Radius for clinical trial and received travel support from Radius and grant support from Amgen. LSS discloses associations with Astrazeneca, Pfizer, Rigel, Eupraxia, Biosplice, EMDSerono, Horizon, Direct, Lilly, Kaniska, Protalix, Chemomab, TLC, SpineThera, Kyoto, PPD, Galvani, Urica, Transcode, Boehringer Ingelheim, Bristol Myers Squibb, Priovant, Roivant, Ampio, Aura, Aurinia, GSK, Xalud, Neumentum, Neema, Amzell, Applied Bio, Aptinyx, Bexson, Bone Med, Bone Therapeutics, Cancer Prevention, Cerebral Therapeutics, Chemocentryx, Diffusion Bio, Elorac, Enalare, Foundry Therapeutics, Galapagos, Histogen, Gilead, Idera, Intravital, Ingel, Kiel Labs, Mesoblast, Mpathix, Minerva, Regenosine, Samus, Sana, StageBio, Theraly, Unity and Viridian. FT reports personal fees from Amgen, Eli Lilly, Fresenius, Stada and UCB outside the submitted work. CC reports personal fees from ABBH, Amgen, Eli Lilly, GSK, Medtronic, Merck, Novartis, Pfizer, Roche, Servier and Takeda, outside the submitted work. NCH reports personal fees, consultancy, lecture fees and honoraria from Alliance for Better Bone Health, AMGEN, MSD, Eli Lilly, Servier, Shire, Consilient Healthcare and Internis Pharma, outside the submitted work. JYR, NMA, JAT, CB, OB, NB, MCD, WHD, ADP, PH, PH, JAK, DPA, RPR, SLS, TVS and AL report no conflicts of interest related to this work.
Funding Information:
The ESCEO Working Group was funded by the ESCEO. The ESCEO receives unrestricted educational grants to support its educational and scientific activities from non-governmental organisations, not-for-profit organisations, non-commercial or corporate partners. The choice of topics, participants, content and agenda of the Working Groups as well as the writing, editing, submission and reviewing of the manuscript are the sole responsibility of the ESCEO, without any influence from third parties. PGC is supported in part by the UK National Institute for Health and Care Research (NIHR) Leeds Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NIHR, the Department of Health and Social Care or the World Health Organisation.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/8
Y1 - 2023/8
N2 - Summary: This narrative review summarises the recommendations of a Working Group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) for the conduct and reporting of real-world evidence studies with a focus on osteoporosis research. Purpose: Vast amounts of data are routinely generated at every healthcare contact and activity, and there is increasing recognition that these real-world data can be analysed to generate scientific evidence. Real-world evidence (RWE) is increasingly used to delineate the natural history of disease, assess real-life drug effectiveness, understand adverse events and in health economic analysis. The aim of this work was to understand the benefits and limitations of this type of data and outline approaches to ensure that transparent and high-quality evidence is generated. Methods: A ESCEO Working Group was convened in December 2022 to discuss the applicability of RWE to osteoporosis research and approaches to best practice. Results: This narrative review summarises the agreed recommendations for the conduct and reporting of RWE studies with a focus on osteoporosis research. Conclusions: It is imperative that research using real-world data is conducted to the highest standards with close attention to limitations and biases of these data, and with transparency at all stages of study design, data acquisition and curation, analysis and reporting to increase the trustworthiness of RWE study findings.
AB - Summary: This narrative review summarises the recommendations of a Working Group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) for the conduct and reporting of real-world evidence studies with a focus on osteoporosis research. Purpose: Vast amounts of data are routinely generated at every healthcare contact and activity, and there is increasing recognition that these real-world data can be analysed to generate scientific evidence. Real-world evidence (RWE) is increasingly used to delineate the natural history of disease, assess real-life drug effectiveness, understand adverse events and in health economic analysis. The aim of this work was to understand the benefits and limitations of this type of data and outline approaches to ensure that transparent and high-quality evidence is generated. Methods: A ESCEO Working Group was convened in December 2022 to discuss the applicability of RWE to osteoporosis research and approaches to best practice. Results: This narrative review summarises the agreed recommendations for the conduct and reporting of RWE studies with a focus on osteoporosis research. Conclusions: It is imperative that research using real-world data is conducted to the highest standards with close attention to limitations and biases of these data, and with transparency at all stages of study design, data acquisition and curation, analysis and reporting to increase the trustworthiness of RWE study findings.
KW - Drug effectiveness
KW - Epidemiology
KW - Fracture
KW - Osteoporosis
KW - Real-world evidence
KW - Registry
UR - http://www.scopus.com/inward/record.url?scp=85162988298&partnerID=8YFLogxK
U2 - 10.1007/s00198-023-06827-2
DO - 10.1007/s00198-023-06827-2
M3 - Article
C2 - 37351614
AN - SCOPUS:85162988298
SN - 0937-941X
VL - 34
SP - 1283
EP - 1299
JO - Osteoporosis International
JF - Osteoporosis International
IS - 8
ER -
