Exom Group Srl, in collaboration with Meteda Srl, announces the release of Genius FIRE Diabetes, the first large-scale eSource infrastructure operating in Europe for more efficient conduction of Clinical Trials in Diabetes.
As is well known, Diabetes is one of the most widespread and disabling chronic diseases in the world, with over 500 million people suffering from Diabetes.
In Italy, the only country where Genius FIRE Diabetes is currently available, the numbers of Diabetes are as follows:
The opportunities for clinical research in Diabetes
As in all therapeutic areas, clinical trials in Diabetes have to deal with a management complexity that involves both the clinical site staff and the sponsor or CRO staff responsible for monitoring.
Unfortunately, this operational complexity inevitably translates into an increase in the time needed to conduct the study and the related costs, which are now reaching unsustainable figures.
For some years now, the digital revolution, also supported by regulatory authorities, has entered clinical research with the aim of modernizing and rationalizing the way sponsors and other stakeholders collect clinical data.
While in many industry sectors, there has been rapid and overwhelming progress in the areas of data collection and management, similar progress in the pharmaceutical industry to embrace electronic solutions in source data collection of clinical trials has unfortunately been slow. A major obstacle has been the difficulty in finding convergence between stakeholders on the technologies needed to implement the eSource on a large scale.
Now, thanks to the FIHR (Fast healthcare interoperability resources) protocol, which is an international standard for the electronic exchange of health information, electronic health record data become available, exchangeable, structured and standardized.
Increases data quality
In a typical study, it is more difficult to find inconsistencies between related variables using traditional data cleaning methods – which are manually intensive and prone to errors. Discrepancies that we do not notice or expect to create inherent quality or compliance problems. Genius Wizards, through a machine learning approach, analyzes data from different sources and formats in real-time, allowing data managers and study managers to avoid spending hours creating reports and identifying patterns and trends from hundreds of thousands of data points, identifying problems that go beyond typical data quality assessments. As a result, data cleaning and queries are also drastically transformed and automated.
Genius FIRE Diabetes
Through this technology Meteda, supplier of the electronic patient record, used by over 90% of Italian diabetes centers, and Exom Group, the first European CRO to conduct digital and virtual studies, have developed an application (Genius FIRE Diabetes) that allows the transfer of a copy of the clinical data of interest, directly from the electronic hospital record (EHR) to the study database.
Genius FIRE Diabetes allows investigators to optimize their tasks by introducing efficiency improvements. Below are some of the other advantages that this application offers :
- Simplified and more accurate collection of information
Patient data recruited from the studies digitally collected at the source are transferred directly into the study database without any further manual intervention by the investigator, thus avoiding the inevitable transcription errors. This effectively eliminates the time delay between the collection of patient data during the visit and their availability in the study database.
- Significant reduction in monitoring activities
Since th ere is a perfect overlap between the data recorded in the study database with the original source data in the EHR, there is no need to perform the Source Data Verification (SDV) during the monitoring visit at the experimental site.
- Reduction of study time
Immediate availability of the data, as soon as the patient has finished the study period, significantly reduces the time to final data cleaning and database lock.
- Reduced study costs
Reduced time and effort also mean significant savings in the overall costs of the study.
- Data exchange & Advanced Analytics
The interoperability of Genius FIRE Diabetes with all the centers that use Meteda’s electronic medical records allows to conduct evaluations and analysis on a large scale both in the feasibility phase, to verify the number of potential patients eligible for a given study, and on a large volume of real-world data or evidence (Rwd-Rwe), which can then be immediately analyzed by the advanced analytics platform (Genius Wizards), directly integrated with Exom Group’s eCRF.
Obviously, the process of extraction and transfer of clinical data through the Genius FIRE application fully meets the requirements of security, controlled access, pseudonymization, and compliance with the GCPs and GDPR.
“This new way of exchanging data between the digital systems used in medical practice and those of clinical trials, represents an extraordinary opportunity for clinical research in diabetes for the benefit of patients, researchers and promoters” – says Prof. Antonio Ceriello, head of the Department of Diabetes Research at the Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, coordinator of the Diabetes Project at IRCCS MultiMedica, Milan and Past President of the European Association for the Study of Diabetes (EASD) Study Group on “Diabetes and Cardiovascular Diseases –
“In particular for Italian diabetology, which for years has standardized the hospital and outpatient records, this is a unique opportunity, not only to significantly improve the quality of data and the efficiency and speed of studies conduction but also to attract study promotors to place many clinical trials in Italy. Italian diabetologists present themselves in the international context of clinical research as a network, not only qualified and reliable but also at the forefront in the use of the most advanced digital solutions in clinical trials. I am confident that this significant change in the management of clinical research in Diabetes will result in a significant increase in both the number of registrations, observational and outcome studies on large numbers, with important cultural and scientific impacts”.
Clinical research in Diabetes now has a technological solution that revolutionizes the classic paradigms of data entry, source data verification, and data management, which, as is well known, are slow, imprecise processes that require intense human work.
Genius FIRE Diabetes simplifies all this, ensuring the highest level of data quality together with their acquisition in real-time and with minimal efforts for both the staff of the study center and the study monitors.
We are confident that, also as a result of the pandemic that has hit clinical research in all therapeutic areas, this new operating mode for clinical trials in Diabetes, eliminating the need for source document verification made directly at the site, together with other technological solutions, such as telemedicine that allows remote monitoring of patients, will be a strong incentive for all national and international promoters to invest in modern, efficient, fast and cheaper clinical trials in Diabetes.