Could EHRs Boost Clinical Trial Recruitment?
Patient recruitment for clinical trials is commonly accepted to be a herculean task. A new platform could make the process a lot quicker and easier – and, crucially, not at the expense of data privacy
Here’s a truism we can all agree on: clinical trials never go as planned.
In an ideal world, pharma companies would be unerring in sourcing eligible patient groups that fit all trial criteria. It wouldn’t take new medicines a decade-long journey from discovery to market place. And drug R&D costs wouldn’t be so inordinately expensive.
Alas, we don’t live in an ideal world. Each and every year, trials are discontinued due to their unfeasibility and poor cost effectiveness, with patients missing out on vital new therapies.
But a new window of opportunity may have presented itself to reduce and resolve the bottlenecks that have become synonymous with clinical research. It comes in the shape of electronic health records (EHR).
EHR is yet to be truly applied in the field of clinical research in the form of a large, scalable data platform model that bridges the gap between pharma and healthcare.
This was precisely the basis for the EHR4CR project, which ran from March 2011 to February 2016. Funded by the Innovative Medicines Initiative (IMI), the project sought to discover a way of enabling clinical trial researchers to sift through millions of medical records in European hospitals to discover potentially suitable patients per hospital.
For the project, IMI, a public-private partnership between the EU and the European pharmaceutical industry, was able to bring together 35 partners, comprised of ten pharma companies and 25 academic organisations, as well as 11 hospitals in five countries.
“The idea of a project consortia was really important,” recalls EHR4CR’s coordinator, Mats Sundgren.
“Because what we wanted to do within the scope of the project was to demonstrate and conduct a proof-of-concept for a scalable research platform for the trustworthy reuse of EHR data to support innovation in clinical research and healthcare operations.”
On the back of the EHR4CR’s completion, Custodix – a Belgium-based specialist life science data company, and one of the project’s partners – launched a commercial platform, InSite (www.insiteplatform.com). The service, based on EHR4CR’s project brief, enables scientists to look through EHRs across a network of European hospitals, allowing them to make decisions over whether a proposed trial is feasible or not.
Presently, the pharma companies involved in EHR4CR are working together as “Champions” to sponsor and recruit new hospitals to join the network and engage in the initiative.
“The ‘Champions’ programme is going really well,” explains Juuso Blomster, MD, head of innovation at Turku University Hospital, Finland, and partner in the project.
“At the moment, we have around 30 hospitals involved spread across Europe for example in Spain, Italy, Belgium, Germany, UK, Poland and Sweden. There is a large interest and hospitals are queuing up to join the system.”
Founded on new methods of real world data utilisation, the platform could speed up trial planning and recruitment so considerably that it is forecasted to slash the time taken to set up and run a clinic trial by three to six months.
“There are a number of arguments in favour of the platform,” says Sundgren, principal scientist and health informatics director within global medicines development at AstraZeneca R&D.
“One concerns the median total cycle time for feasibility is currently estimated to be around 61 days. Sometimes it takes even longer. But with this technology, we could be able to do this in perhaps two or three days. As it’s all data driven, this means we can translate paper-based protocol for a clinical study into searchable items.
“We can also send queries to all hospitals in real-time, while getting their response back regarding how many patients correspond to the different inclusion-exclusion criteria.”
EHR4CR has clearly yielded some impressive outcomes to date. Another upshot of the project has been the formation of the European Institute for Innovation through Health Data, a non-profit collaborative group pooling the brainpower of research groups, hospitals and companies to discover the best means of using and sharing patient data.
However, none of the above would have been possible without assurances over data security, a perennial sticky wicket as so far as the healthcare sector and public trust are concerned.
One of the hardest challenges to overcome for pharma, says Blomster, has been satisfying hospitals that the respective national laws and regulations they abide by when it comes to data security are understood and adhered to. No mean feat, when you are operating a multinational network.
“When you think about Europe, the laws and regulations differ from country to country, albeit all under the EU framework” he says. “So, we really need to be transparent and able to ensure all participants that data privacy and related issues have been taken care of by the book.
“The other challenge in this respect is that some regulations relating to data privacy, such as the GDPR, are in the process of changing. So, appreciating that this could be an issue for hospitals, we have taken a lot of time and effort to really go through all the details with lawyers and regulators to cover these matters.”
According to Sundgren, another part of the reason hospitals have been willing to get behind the InSite network, from a data privacy standpoint, is the credentials behind EHR4CR’s formation. As an IMI project, validated by various stakeholders from across the European Commission – as well as the FDA and EMA – its foundations are built on a clear understanding of data security.
“We joined forces in providing clear arguments and clarification about the data privacy, taking all the measures to comply with the general protection of data security in Europe,” he says.
“If we hadn’t have done that, I don’t believe the EHR4CR project could have taken off. Fortunately, we had a good tailwind behind us, having a fully-blown, completed IMI project in the bag.”
And what of the impending General Data Protection Regulation (GDPR), set to come into play across Europe in May? How much of an impact might this have on the realm of EHR exchange?
“I don’t think it’s going to make that much of a difference,” answers Sundgren. “The pharma industry has always been a very strict industry anyway, the EHR4CR project has been taking the impending GDPR into account from inception, for example by following the privacy by design principle. So I’m confident that the GDPR will not have an impact on the goals we set out in the EHR4CR project.”
Arguably the most notable achievement of the EHR4CR project – and subsequent “Champions” programme – has been getting pharma companies to work together. While, ultimately, they will use the platform for competitive means, there is an acceptance that a general hospital network needs to be created first, which “would be impossible to achieve by just one company,” says Sundgren.
This would suggest that after years of dipping their toes in the digital water, pharma might now be ready to embrace the benefits of EHR exchange with hospitals and HCPs.
“There’s been an awakening,” says Sundgren. “This is a technology that is just starting out, but I really think it’s going to revolutionise the way we conduct clinical trials.”
Mats Sundgren will be expounding his insights at the Real-World Evidence and Access Europe 2018 event in April.