Frequently Asked Questions
The International Severe Asthma Registry (ISAR) is the first global severe asthma registry; a joint initiative where national registries (both newly created and pre-existing) retain ownership of their own data but open their borders and share data with ISAR for ethically approved research.
The ISAR initiative is conducted by Optimum Patient Care Global Limited (OPC), with scientific oversight from the ISAR Core Steering Committee (ISC), academic support from the Respiratory Effectiveness Group (REG), ethical governance from the Anonymized Data Ethics & Protocol Committee (ADEPT) and co-funded by OPC Global and AstraZeneca since May 2017.
By collecting anonymised, high-quality patient-level data via a standardised core set of variables from countries all over the world, ISAR is able to fill the need for a longitudinal, real-life, globally interoperable severe asthma registry.
Bolstered by a collaborative organizational structure, the network of database and clinical experts and its principle of inclusivity/openness with regards to research, ISAR provides the statistical power and opportunity to better understand severe asthma epidemiology across countries and regions and answer important research questions while ensuring the scientific integrity and clinical applicability of the database and its research. Ultimately, ISAR offers an unique opportunity to implement existing knowledge to generate new knowledge by identifying the unknown; thus, driving new research in the severe asthma disease area.
Countries collaborating with ISAR are subject to country-specific ethical regulations and hence, would be required to seek local ethics approval before sharing de-identified, anonymous patient level data with ISAR. Countries have the flexibility to apply for centralised ethical approvals or site-specific ethics approval as required in their country. The ISAR team will provide ethics support and resources to guide the local ethics applications as necessary.
All research projects utilising ISAR data would be subject to approval by the ISAR Steering committee (ISC): as well as ethical approval by the ADEPT committee. The ISC is made up of ~46 pulmonary experts across ~30 collaborating countries who are solely responsible for overseeing the scientific merit of all research proposals while the ADEPT committee made up of database and clinical research experts within the REG; is responsible for overseeing ethical governance of research proposals arising out of ISAR.
Collated by the ISAR network of respiratory and database experts via the Delphi iterative decision making process, ISAR captures the following information: Demographics, Medical History, Comorbidities, Diagnostics, Hospital Resource Utilization, Biomarkers (Blood and Sputum Eosinophils, IgE, FeNO), Asthma Medication, Allergy Tests, Asthma Control (GINA Assessment for asthma control), Adherence and Clinical Management Plan.
ISAR also collects safety-related data across three main events: Cancer, Serious Infections and Anaphylaxis and medication effectiveness data across ten OCS related comorbidities (Osteoporosis, Diabetes, Renal Failure, Anxiety, Depression, Peptic Ulcer, Cataract, Glaucoma, Pneumonia, Cardiovascular Diseases, Obstructive Sleep Apnoea) as well as OCS/ICS doses and reasons for switching from/to/between biologics.
The ISAR data collection process endeavours to maximise existing data available in electronic medical records as well as bespoke national level registries by facilitating the consolidation with incoming data from new registries where primary data collection is supported via electronic Case Report Forms (eCRFs). While ISAR supports data collection via multiple platforms such as REDCap, etc, new registries primarily use the electronic data capture system freely provided by ISAR, OpenClinica; which is specifically designed to collect real-life data. Regardless of the source, patient privacy is always maintained via mandatory anonymisation, or de-identification of individual patient data at the source or at the point of collection and only the health care providers will be able to identify their patients at their local sites.
ISAR international data is hosted at Optimum Patient Care, United Kingdom.
Optimum Patient Care is registered on the Data Protection Register reference: ZA197058 and is compliant with the EU General Data Protection Regulation (GDPR).
As per ISAR’s founding principle, all collaborating countries or their respective contracting bodies (e.g. National thoracic society, severe asthma clinic, etc) own their data and are free to share their data and conduct their own research.
OPC or AstraZeneca do not own any data held in the international repository. Collaborators are only required to share fully anonymized data for research approved by the ISAR Steering Committee and the ADEPT Committee.
ISAR’s EDC platform of choice; OpenClinica, is customized for real-life data capture and is programmed to perform data validation checks at the point of data entry. The system has recently undergone an upgrade to the latest 3.14 version, allowing for enhanced data collection across countries and sites; supporting multi-language browsers and faster page loading.
To further increase efficiency of the data entry process, ISAR is soon looking to launch “OpenClinica Participate” featuring an integrated patient response outcome tool that enables data collection prior to clinic visits via patient surveys.
Aiming to provide a holistic platform that allows clinicians to monitor their severe asthma cohort and hence maximise the data collected via OpenClinica, ISAR is currently in the process of providing an integrated data visualisation platform that charts progressive data collected as well as providing regular data reports that can be used to better inform clinicians on the management of their severe asthma patients.
ISAR adheres to the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. All authors are required to disclose any potential conflicts of interest via the ICMJE Conflict of Interest Form.
The ISAR doors are open to new collaborators and partners using the ‘join the registry’ and ‘register your interest’ options on the ISAR home page. Support is available to set up local registries via the provision of the standardized variable list.