Christian Hebenstreit, Medidata Solutions says there is a huge interest in digital health in Europe and outlines how the pharma sector can make the most of this opportunity.
Digidata
There is a huge opportunity for pharma companies to capitalise on the digital health movement and we see significant interest for this technology throughout Europe.
For starters, this interest in new technology reflects Europe’s demographics. In its developed markets, the populations are aging quickly leading to increased healthcare costs. There’s a real need for technology that can bring down those costs as well as improve our understanding of disease. Wearable sensors and apps can dramatically improve our ability to gather real-time, real-world data from patients.
Bayer’s Barbara Voith, who heads the German pharmaceutical company’s clinical sciences operations group, recently summed it up: “Right now patients, investigators, physicians, health authorities and payers are scrutinising the value of new medicines. We really need to think about how we can optimise drug development in a way that provides meaningful outcomes for patients.”
Pharma companies are exploring new technologies to push the traditional measurements used in clinical trials. Companies like Boehringer Ingelheim are using an end-to-end digital approach in clinical development, from study design optimisation to risk-based monitoring technology.
In a similar approach, Sanofi attaches a digital health strategy to each molecule in the company’s R&D pipeline. Clearly, Europe’s leading pharma companies are embracing the adoption of digital health, and often they are the most progressive in this pursuit.
Within this push towards digital health, mobile health (mHealth) technology is becoming a new focus for innovative life science companies. We recently helped Nestle’s life science team launch a two-year, mHealth-enabled clinical study to assess the impact of nutrition and physical activity in adults with joint discomfort. Patients are equipped with Garmin activity trackers and asked to fill out diary data in Medidata’s Patient Cloud electronic patient-reported outcome (ePRO) app.
Similarly, GlaxoSmithKline teamed with McLaren Group – known for its Formula 1 racing team – to incorporate biotelemetry into its clinical studies. As with most of Europe’s leading pharma companies, GSK anticipates sensor technology, which can collect real-time, continuous patient data, will enable collection of more meaningful, real-world data.
Companies need to go the extra step with strong feasibility studies to promote adoption by patients, healthcare providers and government payers in each country and prove that these sensors and apps are not only safe but effective tools for understanding disease and treatment.
Of course, data privacy is paramount in all this, and the EU has taken a very strong stance on protecting patient data. The EU is adopting regulation meant to thoroughly protect data generated by wearable devices, including activity trackers. The easiest way to have a comprehensive global data privacy policy is to promote the harmonisation of privacy and security measures around the world. When it comes to data privacy, earn the trust of patients, regulators and partners by being better than required.
We opened a data centre in Europe specifically to meet our customers’ data requirements in the region; this was a substantial investment on our part, but we recognize our clients in Europe have specific data requirements that can differ from our US customers.
Despite the challenges that accompany adoption of any new innovation, the promise of mHealth in clinical trials is starting to be realised. The European Commission is launching initiatives to encourage digital health startups and working with organisations to establish mHealth assessment guidelines. The regulators see the value that digital health can bring to address the inefficiencies and cost pressures of clinical development, and they see the promise of new insights that these tools offer. As an industry, we are only limited by our own inertia. As long as we all push forward, Europe’s digital health future is bright.