Australia and New Zealand’s participation in an international big data-sharing platform could be the key to unlocking valuable knowledge on blood cancers and speeding up access to new medicines, delegates attending the Blood 2019 congress have heard.
Professor Brendon Kearney, a consultant physician at the haematology unit at the Royal Adelaide Hospital told delegates that real-world data was becoming increasingly important for evaluating the safety and effectiveness of new drugs and technologies.
“Although reimbursement in Australia requires randomised controlled trials, increasingly with newer drugs RCTs are often not available or usable in terms of registration of the drugs,” Prof. Kearney told the conference.
“A number of registries in Australia have been developed to monitor the impact and outcomes of new treatments but some of these are incomplete and not standardised, creating barriers to a national approach,” he added.
The Harmony Project is a large public-private European Network of Excellence for Big Data in Hematology that comes from a European initiative called the Innovation Medicines Initiative (IMI).
“The idea is to build a high-quality big data platform to harmonise the data that goes in, to speed up drug development, and to include genomics information because one of the challenges we all face is how we integrate genomics information into our clinical databases,” Prof. Kearney explained.
The project is a voluntary scheme that involves a number of major partners including clinical units from a large number of European countries covering about 300 million people, the pharmaceutical industry, healthcare agencies such as NICE, universities and departments of haematology, genomics institutes and patient organisations.
“It’s bringing together quite a comprehensive grouping of organisations all with the common interest of improving outcomes for the treatment of haematological malignancies,” Prof Kearney said.
One key to its success is that the project offers a reimbursement for each clinical data set submitted, according to Prof. Kearney.
“At the moment this is roughly $160, but this can go up or down depending on that particular patient data set, that means that if you work in a larger public unit you would have significant numbers of patients and you could potentially employ someone on that guarantee of reimbursement”.
Another selling point is that the data is open access and is available for haematologists, economists, regulators, ethics, policy makers, regulators and industry (with some access rules).
“It’s quite different from almost anything I’ve seen in clinical medicine in that it’s comprehensive, it’s a standardised and open project that includes both public and private activities… And it bypasses the bureaucratic systems that we live and work in,” Prof. Kearney noted.
Prof. Kearney told delegates that if there was sufficient interest for Australia to get involved then the next steps were to set up a consortium with some clinician leaders to put together a business case and a programme to submit to various organisations for funding.
“A project like this in Australia, and this is a personal view, is probably best housed or based in the ALLG which has the appropriate office and structures to support such a project but it clearly needs the involvement of HSANZ.”
“It is a major undertaking and requires a significant national effort but I think it has been shown that it can work and the harmony people are keen to collaborate,” he added.