The HARMONY project is an incredibly exciting project. It’s a public-private partnership in Europe under the IMI programme, Innovation Medicines Initiative, which is a joint collaboration between the European Commission and the EFPIA pharma industry. Under the IMI there is the Big Data for Better Outcomes programme with all the purpose of speeding up access to medicines for patients.
What are the main goals of the HARMONY project?
HARMONY, it’s comprised of 51 partners and seven of those are pharmaceutical companies and the rest being public partners – academic institutions, payers, policy makers and patient organisations. The key purpose is to build an outcomes-focussed data platform to empower patients, policy makers and physicians and payers to optimise care for patients with hematologic malignancies. In order to achieve that we need to unlock data from the wider population. So, for example, in clinical trials about 3% of patients are enrolled into trials; we’re really, really interested in looking at the 97% of data that exists out there and that sits with organisations across the EU.
How will HARMONY improve patient outcome?
Interestingly from a patient’s angle we are on the cusp of huge waves of innovation. Cancer is being divided up into many, many different diseases; we’re getting a better targeted development of therapies but we’re far away from the real endpoints that matter to patients. So, for example, on the cusp of all this innovation we have had about 70 medicines approved in the last five years and registered but they’re still restricted or delayed in access for patients. So you ask the question how can we speed up access to patients and you have to go back and look at have we assessed the right endpoints in the trials? Have we found the right patients that are going to benefit from the right drug at the right time? Have we aligned with payers, policy makers and patients? Have we selected the right outcomes that we need to measure? And then how do you finally move the system to respect and value innovation that is being produced by the pharma industry?
How will HARMONY manage big data?
Interesting question. So, there’s a lot of information at the moment out there about big data; you don’t pick up any journal or press or article at the moment without a reference to big data. The topic in itself is interesting; what’s interesting here is this project is all around blood cancers and it’s the first of its kind European-wide, spanning over eleven countries. We have worked over the last eighteen months to pick six haem malignancies which are defined; we’ve looked at work packages, all the way from work package 1 which is project management to work package 8 which is legal and ethics. In between that you have a package 2 defining outcomes with patient involvement and peer involvement; you have work package 3 and 4 which look at data access and building a data platform and package 5 on data analytics and 6 on payer integration and EMA integration and 7 is communication dissemination. Now we’re about to kick-start this effort and operationalise key aspects of the winning proposal.
