Big data analytics is beginning to unlock a whole heap of information about how medicines perform in the real world, and as a result, drugmakers are rushing to scoop up patient health records and strike as many deals as possible with technology companies. 

 According to Reuters, having the opportunity to study real-world evidence offers manufacturers a powerful tool to prove of the value of their drugs. This is something Roche in particular, aims to leverage. Obtaining such evidence means collecting data outside traditional randomised clinical trials, the current gold standard for judging medicines. Interest in the field is sky rocketing, with hot areas for studies including cancer, heart disease and respiratory disorders. 

Historically, it has always been difficult to understand how drugs work in routine clinical practice, but the with the rise of electronic medical records, databases of insurance claims, fitness wearables and social media, this has quickly become a lot easier. 

However, as expected this does bring with it a debate surrounding access to personal data. Some campaigners and academics are concerned that the data might be used primarily as a commercial tool by drugmakers and therefore intrude upon patients’ privacy. 

Of course, having access to this information is vital in cancer treatment. But, the interest goes far beyond this. All the world’s major drug companies now have departments focused on the use of real-world data across multiple diseases, and several have even completed scientific studies using information to delve into key areas addressed by their drugs. 

“It’s getting more expensive to do traditional clinical trial research, so industry is looking at ways it can achieve similar goals using routinely collected data,” explained Paul Taylor, a health informatics expert at University College London.

“The thing that has made all this possible is the increasing digitisation of health records.”

In addition, the world’s regulators are seeming to take notice too. U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, believes more widespread use of real-world evidence (RWE) could cut drug development costs and help doctors make better medical choices. 

Under the 21st Century Cures Act, the FDA has been directed to evaluate the expanded use of RWE. “As the breadth and reliability of RWE increases, so do opportunities for FDA to also make use of this information,” Gottlieb said. 

The European Medicines Agency is also studying ways to use RWE in its decision making. 

But, Sam Smith, a campaigner for medical data privacy at Britain’s MedConfidential, is worried that drugmakers’ RWE studies are just a cover for marketing. “How much of this is really for scientific discovery and how much is it about boosting profits by getting one product used instead of another?”

There is also a concern that these types of studies could be susceptible to “data dredging”, where multiple analyses are conducted until one gives the hoped-for result. 

Addressing such problems, AstraZeneca’s head of innovative medicines, Mene Pangalos, explained, “It’s a real problem but I don’t think it’s insurmontable. As people get more comfortable with real-world evidence studies I think it will be much more widely used. I would like to see a world where real-world data can be used to help change drug labels and be used much more aggressively than it is today.”

Looking ahead, it seems that this is the next frontier for drugmakers. Roche Chief Executive, Severin Schwan is even betting that Roche’s leadership in both cancer medicine and diagnostics will put it in a prime position.

“There’s an opportunity for us to have a strategic advantage by bringing together diagnostics and pharma with data management. This triangle is almost impossible for anybody else to copy,” he said. 

“You can have a big debate about whose data it is – the patient’s, the government’s, the insurer’s – but one thing for sure is the pharmaceutical company does not own it. So there’s no choice but to do partnerships,” he added. 

There is no denying that we are going to be seeing a lot more value placed on data. With Apple’s latest iPhone update including a new feature allowing users to view their medical records, Amazon teaming with Berkshire Hathway and JPMorgan Chase on a new healthcare company, numerous start-ups are popping up. 

“You are going to see more deals,” commented Susan Garfield, a partner in EY’s life sciences advisory practice. “Data already has tremendous value and it is going to have increasing value in the future. The question is who is going to own and capture it.”