Actually I’m the coordinator of the project, the full project. I’m Jesús Hernández, I’m working in Salamanca University as a haematologist and also as a full Professor of Haematology at the university. Actually I’m the coordinator; we sent a proposal to the IMI to collect from the very beginning of the project, to be a comprehensive, an inclusive project instead of something very, very particular. We know that this project is one of the first Big Data for Better Outcomes projects and we know that haematological malignancies were out of the scope of the IMI projects before. So what we wanted to do at that time anyway, and now we’re starting to do, is to collect a comprehensive series of universities and hospitals across Europe. This is one of the most important things that we have collected. We have included about 25 institutions, 25 haematology leaders in the different diseases in HARMONY.
Another characteristic from the very beginning for the project was the inclusion of not all but almost all the stakeholders involved in the haematological malignancies. Coming and finishing in the patients, because the patients are the really most important product, the most important thing that we have in the project. So coming from the patients and finishing with the patients and in the middle regulatory agencies, health economists, regulators, payers. So all the instances included and related to haematological malignancies. So my role is to do the coordination, actually and from now, of 53 partners, 45 coming from the public or some companies but mainly publically funded and eight pharma companies. So it is a huge project, a lot of partners, but we want to cover all the possible angles about the haematological malignancies.
What are the main successes of the HARMONY project so far?
Well it is a very good question. The first months that we have developed now, we started in the Salamanca meeting, in the kick-off meeting, nine months ago. So in fact we are still on the first year of the project. We have established good communication, good trust, between the different partners. We have to put in contact the public and the private partners, they have to collaborate and they have to understand each other. Sometimes it’s a problem of communication, it’s a problem of semantics, even, about the different meanings of the words. So we shouldn’t forget that this is not only a scientific project, it’s a project involving several stakeholders, several layers of activity and to put together all this interest and all these people has been one of the major achievements. We have built a database to include the big data coming from patients, coming from the public institutions and hopefully in the near future coming also from the industry. It is also an important achievement because we some agreements with some companies in order to provide datasheets from the clinic or from already published clinical trials. We want also to include associated members. We cannot be one hundred partners but the way to not exclude anybody who is interested in the project is to have a new figure, named associated members, who will be involved in the project not as a full partner but with a special contribution. Here in the Berlin meeting it has been about ten or twelve of the first associated institutions that we have signed a contract with and in the near future we will receive some others and some of these contracts are still being reviewed by the different lawyers from the different institutions.
What do you hope to achieve in the next year or two?
In the next year we hope to start work in the database. The database is already built; it’s placed in Bologna and is built and is able to receive data and is able to start to produce results, to produce analyses of the data. Until now we are just feeding the database with public data instead of non-public data because we have to finalise all the items regarding privacy of data and so on, all these issues that have been resolved in the different work packages that are mainly the basis of the work in HARMONY.
What have you noticed throughout the course of the project so far?
First of all, the first one is that there is real enthusiasm in the haematological community, so all the people are really interested in the project. The project is not only a haematological project it’s also involving all the structures and different structures in Brussels and different associations, let’s say patient associations, pharma and also regulatory agencies and so on. We are planning to establish a stakeholder forum in which several institutions, coming not only from patient associations but also from HDAs, from regulatory agencies, are welcome to be involved in some way in order to sit at the same table, in the same meeting, all the stakeholders involved in the field. So it is something that this is really a critical point.
On the other hand we also have a huge tradition in the analysis of large series of data coming from omics data, coming from next generation sequencing, microarrays. We are also planning to use all this new knowledge and try to relate this new knowledge with outcomes that we can estimate. In haematology we have analysed several outcomes, not only overall survival but also disease free survival and many others like relapse free survival, response to the therapy and so on. But now it will be the way by analysing a series of big data coming to the database that we’ll be able to establish a new set of outcomes that is one the main goals of the project.
Is there anything you’d like to add?
This, from the beginning, has been an open project, everybody is welcome. So we need the support for the real world data, not only for clinical trials from the published data. OK, they are really welcome but also we have to work at a real world level in trying to improve the results, the outcomes, the quality of life of our patients and trying to provide a kind of good news about health sustainability system.