Surfing The Data Tsunami
How pharma is working together with government, regulators, tech companies and their industry peers to establish a strong foundation for health data across Europe
It is now widely accepted that data linkage across healthcare databases is crucial for the future of clinical research. For once, pharma is right at the forefront, and is collaborating with a range of stakeholders including Government, regulators, tech companies, and most surprisingly – their competitors.
Nigel Hughes, Scientific Director at Janssen, has been involved in a number of projects that have seen industry, academia, and policymakers unite in a pre-competitive space to solve the data conundrum. He says data linkage is needed to obtain a “360 degree view” of patients.
One of these is an Innovative Medicines Initiative disease-specific subproject, the European Medical Information Framework, or EMIF. This project is now in its fifth and final year, and has been developing a technology and governance framework for federated real data, as well as exploring the use of health data in identifying predictive biomarkers Alzheimer’s disease and metabolic complications in obesity.
With 10 industry partners involved, and numerous academic partners, Hughes explains that it takes an “open innovation” approach. “It is open and transparent and enables and facilitates extraordinary opportunities.” Another large-scale project he is involved in is seeking to develop a digital network between data sources like hospitals and other institutions, via a common platform to facilitate research.
Notably, the technology is often open source and not proprietary. Hughes also explains: “we aren’t aggregating the data – if we link up with a hospital, the data stays there behind a firewall and we interact with it.” Essentially, the data is mapped under a common data model, which addresses differences in terms of quality, collection methodology, etc. “This isn’t an easy process but it means you can work with all the data together under the common data model and you’re not touching the raw data, unless you need to and under the right agreements. It allows you to work with multiple large scale datasets to do whatever research you need to do.”
An example of this is the EHR4CR (or electronic health records for clinical research) project, which has concluded under the auspices of the IMI but is being supported by industry, who have committed significant funding in order to scale up the program. Hughes explains the idea is that companies involved will be able to access data in each of the countries included in the programme now called ‘The Hospital Network’ to support clinical development and clinical trial feasibility.
Hughes tells eyeforpharma that the key issue is the quid pro quo – what do hospitals and healthcare facilities get in return for allowing access to data? “For industry we have to understand that, apart from money, can we support in terms of insight and analysis, where we could maybe help a hospital learn more about its own data and how that can help in terms of decision-making,” explains Hughes.
It’s clear there are many collaborative efforts taking place in this space, but Hughes admits it has been a “struggle” to reach this point. The technology has evolved rapidly; while access to this can be patchy, the main challenge is operating within the regulatory framework, which often lags behind technological developments.
“We are all struggling with this but the main challenge from a regulatory and policy point of view is how to work within the regulations,” admits Hughes. The introduction of the General Data Protection Regulation (GDPR) across Europe next year is a case in point, but he maintains that the regulation will be open to interpretation.
Society as a whole is concerned about risk which is understandable, says Hughes, but he believes that there should be more talk about the benefits of data sharing, particularly within the health context. “People are very protective of their data, that’s understandable, and in healthcare even more so, it is a very conservative environment.”
Success, therefore, is not necessarily linked to the limits of technology but rather, the people who use it. “Eighty per cent of bioinformatics is about people. It doesn’t matter what technology you have or how much finance you can muster.”
Globally, people are waking up to the need to exploit health data, while industry is also realising they are sitting on potentially a data goldmine, says Hughes. He namechecks Project YODA (Yale University Open Data Access), which has seen the academic powerhouse join forces with Johnson and Johnson to allow institutions to access their clinical trial data for research purposes. One arm of EMIF has seen GSK, Amgen and Janssen, collaborate on the use of placebo data.
“There are all sorts of innovative approaches that we are looking at as industry as a whole, enabled by the technology and this tsunami of data but actually it comes down to ensuring that we have agreed on how to collaborate and again that’s the people factor.”
While this noble work is currently pre-competitive, there will come a point when it is very much the opposite. Is it difficult for such an inherently competitive industry averse to collaboration to work together in this space? Hughes says no – for now at least.
“We are all working together towards a 21st century approach to developing and managing trials for clinical development, we all have an interest in that. Ninety per cent or more of patients in any disease area never go on a trial. We are dealing with a very small cohort of patients and what could help is to enlarge that, which is a good thing all round, for patients who want to get on studies, for institutions who want to do further research, and for us clearly in terms of being able to accelerate what we do because it’s becoming more expensive, more time consuming, and more difficult. At the end of the day, yes we will all be back in the competitive space but it’s about helping the entire healthcare sector and not just the pharma sector.”
Collaboration is hugely beneficial even in the competitive space, Hughes maintains; for example, in Belgium, drug manufacturers contribute to a common platform operated by the Government, ‘HealthData.be’, which then works with the various hospital sites to collect data on patients in a particular disease area. “This saves all the companies having to do this individually themselves – it is all collected in a uniform way and they can see overall what the market is, news, market share etc., and well as outcomes. This provides requirements from the payer point of view,” he explains, adding that the scheme remains unique for now, but is sure to be replicated elsewhere. “Even in the competitive space it is almost imperative to collaborate and we are beginning to realise that. There is a huge amount of diplomacy and consensus that needs to go on between the companies, we don’t always agree – that’s no different to any other large scale multi stakeholder collaborative project, this just happens to be in healthcare. We all care about the same things – outcomes, safety, regulators – so there is a lot of overlap in terms of what we want to achieve.”
Dialogue is key to ensuring success, says Hughes. “It comes down again to getting the people bit right. People need to be aligned in terms of what they are trying to achieve and their common goals. Practical aspects include good project management, which is critical. It’s like the Tower of Babel – lots of very messy human data that we are trying to interpret, and this naturally creates problems. The consequence is that we have very complex interactions at times but as long as everyone is focused on what we are trying to achieve, it can work.”
What does the future hold for those trying to surf the so-called tsunami of healthcare data? Hughes concludes on a cautionary note. “If you look at what has happened in other industries, such as in Silicon Valley and social networks and apps, what we have sleepwalked into is the biggest surveillance system in the world. We are all monitored, tracked and surveyed, all the data that we share on our smartphones goes to Google, Facebook, Twitter and Instagram which are free to us but we are the product. A GP might ask someone to share their medical data for research purposes and they will say no, I don’t want to give my data to industry, but then they leave the surgery and they are already on their phones sharing the outcome of the consultation with their friends and families. There is a strange perception about privacy and the use of our data, but we are haemorrhaging huge amounts we don’t discuss.”
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