Real-world evidence: 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)

Rebecca J. Moon, Jean Yves Reginster, Nasser M. Al-Daghri, Jotheeswaran A. Thiyagarajan, Charlotte Beaudart, Olivier Bruyère, Nansa Burlet, Manju Chandran, Mario Coelho da Silva, Philip G. Conaghan, Willard H. Dere, Adolfo Diez-Perez, Peyman Hadji, Philippe Halbout, Mickaël Hiligsmann, John A. Kanis, Eugene V. McCloskey, Sif Ormarsdottir, Daniel Prieto-Alhambra, Régis P. RadermeckerRené Rizzoli, Yousef Al-Saleh, Stuart L. Silverman, Lee S. Simon, Friederike Thomasius, Tjeerd van Staa, Andrea Laslop, Cyrus Cooper, Nicholas C. Harvey

Research output: Contribution to journalArticlepeer-review

44 Downloads (Pure)

Abstract

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.

Original languageEnglish
Pages (from-to)1283-1299
Number of pages17
JournalOsteoporosis International
Volume34
Issue number8
DOIs
Publication statusPublished - Aug 2023
Externally publishedYes

Funding

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, Nestl\u00E9 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. 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.

FundersFunder number
Amgen
ESCEO
Leeds Biomedical Research Centre
National Institute for Health and Care Research
Radius and Amgen
Medical Research CouncilMR/P020941/1

    Keywords

    • Drug effectiveness
    • Epidemiology
    • Fracture
    • Osteoporosis
    • Real-world evidence
    • Registry

    Fingerprint

    Dive into the research topics of 'Real-world evidence: 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)'. Together they form a unique fingerprint.

    Cite this