Abstract
Regional and/or national severe asthma registries provide valuable country-specific information. However, they are often limited in scope within the broader definitions of severe asthma, have insufficient statistical power to answer many research questions, lack intraoperability to share lessons learned, and have fundamental differences in data collected, making cross comparisons difficult. What is missing is a worldwide registry which brings all severe asthma data together in a cohesive way, under a single umbrella, based on standardized data collection protocols, permitting data to be shared seamlessly. The International Severe Asthma Registry (ISAR; http://isaregistries.org/) is the first global adult severe asthma registry. It is a joint initiative where national registries (both newly created and preexisting) retain ownership of their own data but open their borders and share data with ISAR for ethically approved research purposes. Its strength comes from collection of patient-level, anonymous, longitudinal, real-life, standardized, high-quality data (using a core set of variables) from countries across the world, combined with organizational structure, database experience, inclusivity/openness, and clinical, academic, and database expertise. This gives ISAR sufficient statistical power to answer important research questions, sufficient data standardization to compare across countries and regions, and the structure and expertise necessary to ensure its continuance and the scientific integrity and clinical applicability of its research. ISAR offers a unique opportunity to implement existing knowledge, generate new knowledge, and identify the unknown, therefore promoting new research. The aim of this commentary is to fully describe how ISAR may improve our understanding of severe asthma.
| Original language | English |
|---|---|
| Pages (from-to) | 805-814 |
| Number of pages | 10 |
| Journal | Chest |
| Volume | 157 |
| Issue number | 4 |
| Early online date | 12 Dec 2019 |
| DOIs | |
| Publication status | Published - Apr 2020 |
Bibliographical note
Funding Information:Currently, ISAR benefits from the support of three collaborators. It is overseen by four governing bodies safeguarding continuance of the registry into the future, and ensuring ISAR research is ethical, clinically appropriate, and continues to bring genuine value to patients, public health, and health care. ISAR is a registered data source on European Network of Centres for Pharmacoepidemiology and Pharmacovigilance asthma ( http://www.encepp.eu/encepp/viewResource.htm?id=24389 ). The core collaborators currently include the following: Optimum Patient Care Global (OPC), the Respiratory Effectiveness Group (REG), and AstraZeneca. OPC is an organization which specializes in delivering medical research and services to improve the diagnosis, treatment, and care of chronic diseases. It has a long-standing record of delivering clinical support services and global research by developing enhanced quality databases and bespoke datasets for academic research and global registries with the aim of improving patient outcomes. REG is an investigator-led, not-for-profit research initiative, promoting the value of real-life research. ISAR’s four governing bodies include the ISAR Steering Committee (ISC) (comprising 48 experts in severe asthma research from 29 countries and medical experts from AstraZeneca), REG, the Anonymized Data Ethics & Protocol Transparency (ADEPT) Committee, and the ISAR Operational Committee. The ADEPT Committee is commissioned by REG to review ISAR research protocols for their scientific quality and rigor. The ISAR Operational Committee includes participating country representatives (eg, country lead, deputy, data managers) and is involved in the day to day running of ISAR.
Funding Information:
Financial/nonfinancial disclosures: The authors have reported to CHEST the following: G. W. C. has received research grants and lecture or advisory board fees from A. Menarini, Alk-Abello, Allergy Therapeutics, Anallergo, AstraZeneca, MedImmune, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia, Danone, Faes, Genentech, Guidotti-Malesci, GlaxoSmithKline, Hal Allergy, Merck, MSD, Mundipharma, Novartis, Orion, Sanofi-Aventis, Sanofi, Genzyme/Regeneron, Stallergenes, UCB Pharma, Uriach Pharma, Teva, Thermo Fisher, and Valeas. M. A., T. N. T., and J. Z. are employees of AstraZeneca, a cofunder of the International Severe Asthma Registry. A. A. has received lecture fees Bayer, Boehringer Ingelheim, Berlin-Chemie Menarini, Chiesi, GlaxoSmithKline, MSD, Norameda, Novartis, and Orion; sponsorships from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, GlaxoSmithKline, MSD, Norameda, Novartis, Roche, Teva and United Therapeutics; and research support from Bayer, CSL Behring, GlaxoSmithKline, Norameda, Pfizer, and Takeda; and has been a member of advisory boards for AstraZeneca, Boehringer Ingelheim, CSL Behring, GlaxoSmithKline, MSD, Novartis, Roche, Sanofi, Shire Pharmaceuticals, and Teva. E. B. has received lecture or advisory board fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi/Regeneron, and Teva; and research grants to her institution from AstraZeneca, GlaxoSmithKline, Novartis, and Teva. L. B. has received lecture or advisory board fees from Alk-Abello, Airsonett, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis and TEVA. U. B. Unnur Bjornsdottir receives gratuities for lectures/presentations from AstraZeneca, Sanofi and Novartis. A. B. has received speaker fees and grants to his institution from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, and Novartis for unrelated projects. G. G. B. has received honoraria for lectures from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Teva; and is a member of advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi/Regeneron, and Teva. B. G. C. declares grants from Chiesi; personal fees for advisory board activities from Chiesi and AstraZeneca; and payment for lectures/speaking engagements from Chiesi, Novartis, Menarini, and AstraZeneca, outside the submitted work. R. W. C. has received honoraria for lectures from Aerogen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Teva; is a member of advisory boards for GlaxoSmithKline and Novartis; has received grant support from GlaxoSmithKline and Aerogen; and has patents in the use of acoustics in the diagnosis of lung disease, assessment of adherence, and prediction of exacerbations. P. G. G. declares speaker fees and grants to his institution from AstraZeneca, GlaxoSmithKline, and Novartis for unrelated projects. L. G. H. is Academic Lead for the UK MRC Consortium for Stratified Medicine in Severe Asthma - Industrial Pharma partners Amgen, AstraZeneca, Medimmune, Janssen, Novartis, Roche / Genentech, GlaxoSmithKline, and Boehringer Ingelheim; prior project grant funding from Medimmune, Novartis UK, Roche / Genentech, and GlaxoSmithKline; has taken part in Advisory Boards / Lectures supported by Novartis, Roche / Evelo Biosciences, Genentech, GlaxoSmithKline, Teva, Theravance and Vectura; has travel funding support to international respiratory meetings (AstraZeneca, Chiesi, Novartis, Boehringer Ingelheim, Teva, and GlaxoSmithKline) and has taken part in asthma clinical trials (GlaxoSmithKline, Schering Plough, Synairgen, Novartis, and Roche / Genentech) for which his institution was remunerated. M. H. has received grants-in-aid, speaker fees, and fees for serving on the advisory boards of; GlaxoSmithKline, AstraZeneca, Novartis, Teva, and Sanofi, all unrelated to the current manuscript, and all paid to his institutional employer Alfred Health. E. H. participates in speaking activities and industry advisory committees for AstraZeneca, Sanofi-Genzyme, GSK, Novartis, TEVA, Circassia and Nestlè Purina. T. I. declares grants from Astellas, Boehringer Ingelheim, Daiichi-Sankyo, Kyorin, MeijiSeika Pharma, and Teijin Pharma; and declares lecture fees from Kyorin. R. C. J. declares grants from AstraZeneca, GlaxoSmithKline, and Novartis; and personal fees for consultancy, speakers fees, or travel support from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Nutricia, OPRI, and Pfizer. C. K. R. declares consultancy and lecture fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mundipharma, MSD, Novartis, Sandoz, Takeda, and Teva-Handok. S. L. declares receipt of lecture (personal) and advisory board (to employer) fees from AstraZeneca, Boehringer Ingelheim, and Novartis. L. A. L. declares personal fees for consultancy and lectures from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, Orion Pharma, Sanofi and Teva; personal fees for consultancy from ALK; research grants for academic research on respiratory diseases from several Finnish foundations. A.-H. M.-Z. declares unrestricted grants from Boehringer Ingelheim, GlaxoSmithKline, and Novartis; personal fees for advisory board activities from AstraZeneca and Boehringer Ingelheim paid to Amsterdam UMC; travel grant from Chiesi. N. G. P. declares research support from Gerolymatos, Menarini, Nutricia, and Vian; and consultancy/speaker fees from ALK, ASIT, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, HAL Allergy, Menarini, MSD, Mylan, Novartis, Nutricia, and Sanofi. V. P. declares (in the last 3 years) honoraria for speaking at sponsored meetings from AstraZeneca, Chiesi, GlaxoSmithKline, and Novartis; travel grants from Chiesi and Novartis; consultancy fees from ALK, AstraZeneca, Boehringer Ingelheim, Mundipharma, and Sanofi; and funding/grant support for research projects from a variety of government agencies and not-for-profit foundations, and AstraZeneca, Chiesi, and Menarini. L. P. L. declares nonfinancial support, personal fees, and grants from Teva; nonfinancial support and personal fees from Boehringer Ingelheim, Esteve, GlaxoSmithKline, Mundipharma, and Novartis; personal fees and grants from AstraZeneca and Chiesi; personal fees from Sanofi; and nonfinancial support from Menairi, outside the submitted work. M. P. declares personal fees and nonfinancial support from AstraZeneca and GlaxoSmithKline. Y. T. declares honoraria from Kyorin Pharma and Teijin Pharma and research funding from Kyorin Pharma and Meiji Seika Pharma. E. W. has received advisory board fees from AstraZeneca. She has been an investigator on clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Novartis, Teva, and National Institute of Allergy and Infectious Diseases (NIAID) for which her institution has received funding. L. B., V. A. C., I. C., N. E., N. H., and C. A. P. are employees of Optimum Patient Care Global, a cofunder of the International Severe Asthma Registry. T. L. L. declares educational grants from AstraZeneca, Bayer, Boehringer Ingelheim, Care Pharmaceuticals, GlaxoSmithKline, Mylan, Novartis, Mylan, and Teva. D. B. P. has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartism, Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology. None declared (V. B., G. C. C., J. M. F., M. K. S., D. L., C. M. P., M. S., Y. S. C., and R. B. M.).
Publisher Copyright:
© 2020 The Authors
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
Keywords
- ISAR
- severe asthma
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Critical Care and Intensive Care Medicine
- Cardiology and Cardiovascular Medicine