May 12, 2021 11:04 - x 00, 0 - 00:00
iSanidad interviewed HARMONY Leaders Guillermo Sanz and Jesús María Hernández Rivas. iSanidad is the leading Spanish information portal for doctors and healthcare professionals.
Since 2017, the HARMONY Alliance, has managed to collect data from 40.000 patients in the HARMONY Big Data Platform. Approximately, another 30.000 will be added to the Platform shortly. The information collected comes from more than 17 European countries and covers the entire spectrum of hematological tumors. All data, provided by more than 100 organisations collaborating within the HARMONY Alliance, have been anonymized and harmonized, observing the different applicable laws on privacy and security.
“When it comes to cyber security, health data requires the highest security standards and this is established by the regulatory authorities of the European Union,” highlights Dr. Guillermo Sanz, Head of the Clinical Hematology Section at Hospital Universitario La Fe from Valencia and Co-Chair of the HARMONY Alliance. HARMONY has developed a Big Data Platform. The technical measures and procedures developed by the HARMONY Partners, both public and private, that handle the data included in this platform are very demanding, guaranteeing the privacy and protection of patient data.
“There is a specific need in the pharmaceutical sector that this data cannot be hacked,” insists Dr. Sanz, also president of the Valencian Association of Hematology and Hemotherapy. “For this reason, we have worked with multidisciplinary teams, with specialized offices in this regulatory field and with disruptive technologies capable of responding to all the requirements that ensure the quality and protection of people’s data”.
Guaranteeing harmonization of the shared data and protection at all times is a very difficult task, because each institution collects data in a different way in different units of measure and with different codes. We are addressing this complexity now,” says Dr. Jesús María Hernández Rivas, specialist of the Hematology Service of the University Hospital of Salamanca and Coordinator of the HARMONY consortium.
“Thanks to this work, they are becoming available to analyze large amounts of data on some pathologies. Not all the teams dedicated to each of the diseases included in the project are going at the same pace, but there is already information on Acute Myeloblastic Leukemia, Myeloma and Chronic Lymphatic Leukemia. And very soon we will have results in Acute Lymphoblastic Leukemia and Myelodysplastic Syndromes. The process to transfer data from a public entity can last between six months and a year”, concludes Dr. Hernández Rivas.
In October 2020, the HARMONY Alliance took a step further with the launch of HARMONY PLUS, which has a funding of 12 million Euros for the next three years. Dr. Sanz identifies three key aspects that explain the ‘expansion’ of the project: “In the first place, the large number of participants that have been involved, all pursuing the same objective. Something that was seen as a potential weakness, has finally turned out to be a strength. Secondly, the close and effective cooperation between the different partners that was displayed in the mid-term evaluation of the project was very positively received by the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA)”. And finally, the consortium is already working with the data transferred so far”.
Beyond technical security measures all data transferred to HARMONY is regulated by contract. For this reason, the data transmission procedure is sometimes complex. “The process to transfer data from a public entity can take between more than six months and a year. The transfer does not depend on the researcher but on the legal department associated with that scientist” emphasizes Dr. Hernández Rivas, who is also a professor of Medicine at the University of Salamanca. Dr. Sanz: "If we were to get the EMA to accept this type of trial in the coming years, it would allow studies with new single-branch drugs". Dr. Hernández Rivas: “The challenge consisted in reusing the updated data of the patients and entering those of both the public and the private side of the consortium harmonized in a common repository”.
The fact has stimulated the interest of not only of IMI and EFPIA, but also of the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), who have a large amount of data, underlines the coordinator of the consortium. Dr. Hernández Rivas highlights the importance that it can have even in less common hematological diseases: “For example, these institutions do not want to know only what happens in mantle lymphoma, but also what happens in men with this disease and who are between 50 and 60 years old. Any clinical trial will provide three patients with these characteristics. We can offer 300 and thus it is easier to know the impact of a drug on an age segment”.
The expansion of the project allows to point towards new objectives. In its early days, the HARMONY Alliance project did not address all hematologic malignancies. "This had generated complaints from the hematology community," admits Dr. Hernández Rivas. “HARMONY Plus already includes data for all hematologic tumors. Second, the consortium seeks to make a qualitative leap. We need deeper or more genomic data, probably not for all diseases, because not all have the same development in the field of genomics, however in some of them it would be important to add DNA sequencing data with data from RNA-Seq or from methylation”.
The HARMONY Data Quality Supervision Committee establishes the criteria to evaluate the data and that those cases that pass the filter are useful for the investigation. HARMONY PLUS is doing a very thorough job to ensure data quality. The Data Quality Supervision Committee establishes the necessary criteria to evaluate the data and ensure that those that pass the filter are useful for the investigation. “Once a cooperative group decides to enter HARMONY and submit their data, there are systems that allow to see variables out of range, the number of variables that are blank, and the final effort assessment. Through the cost matrices, more value can be given to a variable depending on the importance it could have for the projects that are being developed or that may be developed,” underlines Dr. Sanz.
The HARMONY Alliance seeks to overcome, in this new stage, the European borders. Another objective would refer to the creation of historical control arms. Hematological diseases are very diverse and some of them require follow-ups of over 15 years. "We are achieving this in Myeloma, with data from patients with a mean follow-up of 10 years, which makes it a unique series," emphasizes Dr. Hernández Rivas. “This challenge would impact access to new drugs: “If we were to get the EMA to accept this type of trial in the next few years, it would allow studies with new single-branch drugs that could be compared with the standard. This would facilitate new drugs become available faster,” claims Dr. Sanz.
GMV, the HARMONY Alliance IT Partner, has developed the HARMONY Big Data Platform and is responsible for the harmonization of shared data. “The health sector - both in clinical practice and in research - is not alien to digitization or the incorporation of tools such as Big Data or Artificial Intelligence. According to data from Forbes magazine, in the year 2025, Artificial Intelligence (AI) systems will be used and implanted in 90% of hospitals in the United States and in 60% of those in the rest of the world. The use of these tools has clear advantages, but for their correct use we must guarantee both the privacy and the quality of the data, being GMV a forerunner in the development of technological platforms based on the concepts of security by design and privacy by default. HARMONY's platform is designed around these two principles, enabling secure data analysis using AI and advanced statistical tools", contributes Rubén Villoria Medina of GMV Soluciones Globales Internet and Lead HARMONY Data Access.
The HARMONY Big Data Platform is a central data base where the anonymous data donated by HARMONY Partners and HARMONY Associated Members is collected securely - following all legal and ethical requirements - harmonized and then analyzed. Here emerge various data sets shared by different data providers – hospitals, research institutes, pharma companies - from interventional, and non-interventional trials. Read more >
This interview was published in iSanidad on 30 April 2021. Link to the original article >
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