Yes, actually I’m leading the Work Package 2 or coordinating Work Package 2, together with Renate Schulze-Rath from Bayer Oncology. I’m a haematologist oncologist by training and I was involved in the project right from the beginning also when we were applying for the call. I’m very excited to see the project develop so well.
Are you excited to see such a large group of people working towards a common goal?
Yes, definitely. It’s really great that we could put together so many different groups also, that it’s not only academic people that are interested in building up this database but also HDAs, industry and this will be also the really good thing in the project that for the first time we will put together the public data together with data that comes from pharmaceutical sponsored trials. This will be a great opportunity.
What have you worked on so far during the project?
The main task so far was to build up the platform, HARMONY itself. When we had the kick-off meeting in January we started from scratch so the database is now in place, it also has been certified so we can now really start to enter the first datasets. In parallel we have identified the first datasets that can go in there and the biggest problem we were facing so far is to overcome the regulatory hurdles with regards to informed consent, how can we use the data, can we use it across Europe, can we put it in one common place? But there we have also now come up with a good solution that is practical and I’m really hopeful that we can put in the first dataset before Christmas.
So what’s the next step?
Yes, definitely, the next step will be then to get as many datasets in there as possible, high quality datasets that also will allow us to answer the questions which we want to address. Let’s say within the next year we will already gather a significant number of datasets that allow us then also to really embark on the important outcome questions which we had in mind when we wrote the HARMONY protocol.
Are you helping other projects of this nature to avoid similar hurdles?
Yes, definitely. The goal here is that we also can then come up with a uniform unique informed consent, for example, which you can use then for other big data projects; that we can share the solutions which we have come up; that we can also use the retrospective data where these consents are not available and nevertheless can use the data a second time. Because this will be very valuable for society without putting the individual risk at additional harm that this data can be recognised. So I think we are setting standards also for other IMI projects here.
