The world of clinical trials & digital health

The emergence of mobile, digital, and wearable devices has marked a shift in the way technology inhabits our everyday lives. At the touch of a button, many of us can find out the latest news, contact our loved ones, or trawl through a plethora of apps designed to capture our attention.

Technology has bled into a large majority of our everyday lives, so it’s no wonder that healthcare has started to take advantage of the tools at our disposal. 

We spoke to clinical technology company Medidata Solutions, to understand how the company is utilising digital health to aid clinical trials. Glen de Vries, president and co-founder of Medidata, recently spoke to Digital Health Age about the clinical trials environment.

De Vries begins by giving some background on the company.

“Medidata was founded 17 years ago by people who worked on clinical trials – not just industry trials, but academic research as well”.

He continues, telling me that they were frustrated about how difficult it was to do certain things within clinical trials, both operationally and scientifically. What Medidata does is provide an online platform for clinical trial professionals and patients, through which they can utilise data to help produce better outcomes.

The company is helping drug developers realise the benefits of using digital devices, working with sponsors and their CRO partners to incorporate mobiles, apps, medical devices, wearables and other new types of technology channels to collect patient data in clinical trials. De Vries tells me that digital devices are “things that are related to the future of medicine and how wellness will be managed. We’ll figure out how patients can help themselves through these digital technologies.”

It’s an important point to make. In the UK the NHS is heavily burdened by a lack of funding and staff, making it difficult for the organisation to maintain a quality patient care service. This, alongside ageing populations and poor medication adherence, means that solutions are needed to help reduce dependence on healthcare providers, whilst also helping to maintain patient health. Digital technologies have the potential to do this.

Deloitte’s Connect Health report states that: “Mobile technologies can empower patients and carers by giving them more control over their health and social care needs and reducing dependence on healthcare providers for information about their health”.

Medidata’s platform doesn’t just rely on digital devices though. It’s a multifaceted service all wrapped up in analytics. The company’s Patient Cloud for instance, consist of three things; ePRO, an app where patients can input data relating to how they think about their own health; SensorLink, where medical and consumer devices are integrated so clinical trial sponsors and their CRO partners can measure patients’ activity; then there’s AppConnect, a system where companies can use their own apps in trials alongside Medidata’s cloud infrastructure.

De Vries states: “We’ve helped people run better clinical trials for a large part of our history, now we’re helping to create better drugs and devices by helping them look at all this data that’s flowing through our platform.”

There are plenty of examples to show just how Medidata is supporting life sciences companies. Last year the company worked with pharmaceutical company, GSK (GlaxoSmithKline) on a clinical trial that involved rheumatoid arthritis patients. It was the first clinical trial to use Apple’s Research Kit software, alongside support from Medidata. 

“It went great. They were able to enrol patients because they were doing it in a digital way. What they did was look at patients with rheumatoid arthritis. They interacted directly with patients, who self-enrolled in the study, carried their phone with them and did some exercise. The whole idea was what to find out what matters to rheumatoid arthritis patients. What should be the things that we’re looking at in our research projects? What are the endpoints that patients care about which will drive their desire to have a certain medication, or be defined as a good outcome when they’re working with their physician?.” de Vries said.

Medidata’s use of technology, as well as other life science companies, points to the way in which healthcare is changing. De Vries discusses the importance of digital devices and the ways in which clinical trials can acquire data from them.

He states: “If you look at the way people think about improving therapies before now, most of the measurements about a patient were done when you physically had that person in front of a healthcare professional. The physical limitation is that you have this very staccato view of a patient. By leveraging sensors, we can get away from the idea that we have to physically connect with the patient at a specific moment in time, when they’re with a healthcare professional.”

The patient is a very important point that de Vries keeps going back to. We often hear about the ways in which medicine benefits a patient’s health, but rarely do we hear about the ways in which medicine affects a patient’s quality of life. With cancer patients, for example, what’s best for the patient, can often seem to equate to how much longer that particular drug will extend their life. 

Medidata, as de Vries states, is “looking at quality of life data in new ways that will completely change the way we look at drugs and devices and whether they are worthy of being prescribed, or worthy of being paid for.”

It’s a lofty goal to set, but it is also one that appears possible if data is utilised in the correct ways to benefit patients and healthcare.

But whilst the promise of digitised healthcare settings and clinical trials seems beneficial, de Vries is quick to warn me about how data can be misconstrued as an absolute solution. After all, the app market is saturated with software designed to monitor our health. It’s estimated that the number of health apps on iOS and Android has more than doubled in 2.5 years to over 100,000. Knowing the reliability of all of these apps is impossible, and clinical trials depend on accuracy to be able to offer the best results.

But despite his warnings de Vries is optimistic about how data can be used in clinical trials.

He states that there is rigorous work that needs to be done surrounding digital data and the patient’s usage of it, but ultimately the payoff could be huge. An aim towards precision medicine, which takes into account particular specific variables to treat patients, is a goal that de Vries believes in, and data could be an answer to that.

“Can we figure out how to practice precision medicine in a more productive way for patients and a more economically feasible way for healthcare systems like the NHS that need to accomplish that?.” he asks.

The question doesn’t need an answer, the widespread use of technologies that de Vries has talked about shows that clinical trials are already adopting digital technologies. The future will only reveal more exciting research.