HARMONY is based on the patients and it’s based on the patients with leukaemia, with lymphoma, with myeloma, with myelodysplastic syndromes; also in childhood patients with haematological malignancies. We want to generate, we want to build up a large database of patients but not a database in which we will include any kind of data. We want to work from a project, from a specific project, asking or trying to reply to specific questions; the hot questions, important questions, from the patients, from the different patients that we have defined in the last ten years.
In haematology there are a lot of things that have been more or less resolved but there are still unmet questions and unmet problems that we have to resolve. One way to resolve these questions is to build up, to share, to have a quite large, a quite huge, database in which we will be able to collect thousands and thousands of patients to provide the best approach and the best kind for the analytics of this data. This is the reason why HARMONY is integrated in the Big Data for Better Outcomes. This is a programme led by the IMI office and led by the European Commission in which we will be one of the first projects in health that will use the big data to resolve the questions that we have to resolve – which therapy is better? Which is the quality of life for the patients with this kind of therapy or this other? We are not talking about hundreds of patients, we are talking about thousands of patients. As haematological malignancies are not really frequent, they are really not prevalent diseases, so we have to share the data. The data are there, the data are in the different working co-operative groups in the different countries in Europe but usually they are a little bit closed to these countries. We have to try, we are now trying to open these databases to share the data in order to provide the answers to the hot questions. These questions will be different from the acute myeloblastic leukaemia than for the acute lymphoblastic or chronic lymphocytic leukaemia and this is the reason why we are planning to work by projects.
How long before we can expect to see an impact on patient care?
This is a recurrent question. First of all, I have to tell you that this is a scientific project but also we have to include patients, we have to include regulatory agencies, so it’s really a social project, it is not only a scientific project because of the involvement of the several stakeholders, mainly patients, advocacies, HDAs and other institutions. So it is something that is… let’s say it’s a much more comprehensive project, let’s say a social project.
The project is scheduled for five years and usually the impact on the patients is quite difficult to be established, so to be pre-established. So for the different projects it is quite difficult to focus in one year we will see or in a couple of years. Our aim is also to provide or trying to short the period of time of a drug at the time that a drug is provided or is checked for the first time and the time that the drug is coming to the bedside. So now it is about ten years so we are fighting, we are expecting to reduce this time, even because we have to be able to sit at the same table all the stakeholders involved in the field. In that way we should be able to shorten this period but I don’t know if it will achieve in three or four years. But what I keep in mind that it is important to reduce and to consider the therapy of a haematological patient in a different way like we are considering the therapy of, let’s say, hypertension or diabetes. Because diabetes is so frequent that you can engage, you can recruit let’s say 10,000 patients without any kind of problem. Here and now we are working more and more for a personalised therapy which with a certain mutation and for this mutation we will have a specific therapy. But this mutation is so rare that maybe you detect this mutation let’s say in three cases in one country in one year so it is not possible to do a clinical trial in that way.
How did you go about the process of involving so many partners/members?
We tried to involve everyone who was really in charge or related to the haematological malignancies. This is an open project; in fact, we are involving several partners as a full member but we are also involving associated members. The associated members are mainly the working cooperative groups, some patient associations. Because according to the IMI rules we cannot do a consortium of 100 or 150 partners so it is something that is clear. I think everybody accepted these kinds of rules. We are now about more than one hundred people; here in this meeting it is 130 people attending, working with also the pharmaceutical companies so at the same time in the same page. So it is an open project so we are still receiving proposals from the associated members to become a member and we are really open to all of these people who we are able to come and to join us and to produce data in a very positive way so this is important.
Also it’s important to have this meeting like we have this kick-off meeting here in Salamanca because we feel that we have to do a lot of interaction between us. Because sometimes we don’t understand each other, we are talking in a different language and sometimes it takes time to sit in the same room and to start to talk OK, which are our goals? Our goals are to improve the quality of life, to improve the survival of the patients so let’s go to do it and to work in the same way. It’s not easy to do that but it is the way to start to work and I’m quite sure that future projects will do it in the same way on the same page.
