The demands of regulators and payers are holding back the approval of new drugs and reducing the return on a product for the developers, but according to Glen de Vries - President of the clinical trials services firm Medidata - efficacy and effectiveness data could be brought about earlier through the use of Big Data driven biomarkers.
De Vries was speaking at last week’s FT Global Healthcare and Biotech Conference in London, UK, where he told delegates the advent of mobile health (mHealth) devices would drive changes in the way clinical trials are conducted.
Wearable Devices
“[Wearable health devices] are a way of gathering all the connected information screening off our bodies in real-time in a completely objective way to inform estimations in safety and efficiacy, and I think this is one of the most important opportunities in curing that R&D malaise that exists today.”
As an example, he high-lighted how the 6 minute walk (6MW) test, often used to gather information about a patient in clinical trials, could be revolutionised using unbiased data mechanically gathered from a device worn by a trial participant outside of a clinical setting.
“We can start to create a picture of the patient’s state not just what they are doing for 6 minutes in front of a doctor where they are going to behave differently, but a real world picture of what the patient is doing,” he said, answering questions about the effect a drug has beyond basic reactions to whether it improves a patient’s overall quality of life.
Big Data
He spoke about the recent collaboration with GlaxoSmithKline to evaluate the impact of mHealth devices in clinical trials.
While the results are yet to be published, de Vries said levels of data being collected were enormous (over four gigabytes of data per hour streamed from each participant). For all participants in trials where Medidata is involved, the level of data collected is equivalent to that of the Large Hydron Collider, he said.
“So we have an opportunity as an industry to create scientific instrumentation on par with some of the greatest scientific instruments created by man, and take advantage of in outcome of clinical trials.”
Digital Biomarkers
“We are now in the beginning of the age of the digital biomarker,” he announced. With such amounts of data there is “a whole new class of information that we can look at,” and when compared with information gathered by consumer devices made by firms such as Apple, Google and Samsung – the “greatest shared control data sets of all time” – industry can create predictive models.
Some companies will begin embracing digital biomarkers and using them in conversations with regulators and payers within five years, he said, yet those firms that don’t adopt digital biomarkers by 2025 are unlikely to exist, he warned.
Tipping Point
Outsourcing-Pharma.com challenged de Vries as to his predictions of industry adoption.
“We have clients who have strategies based on redefining the way efficacy is demonstrated in particular indications by using mHealth generated digital biomarkers/surrogate endpoints,” he told us, and the tipping point will come once a pharma company is successful in convincing a regulator or payer that such data is more valuable than the standard.
“As soon as a life sciences company is successful in going to market with a digital biomarker everybody else in that indication is going to have to catch up.” He added the partnership with Big Pharma firm GSK “is a very clear statement of how important it is to understand and how strategic it is going to be.”
“That competitive dynamic could propel acceleration of these types of technologies at a rate that is surprising compared to how life sciences companies adopted technologies in the past.”