Patient health records, real world evidence and you

Image credit:  Rawpixel .

Image credit: Rawpixel.

Device makers and biotechnology companies may want to take notice of recent developments in the intersecting worlds of pharmaceuticals and technology.

In February 2018, Roche (SWX: RO) announced plans to acquire Flatiron Health, a privately-held healthcare company specializing in electronic health record (EHR) software and data analytics (or, as the press release somewhat quaintly states, “the curation and development of real-world evidence”) focused on cancer research. Roche has held a minority interest (12.6%) in Flatiron Health and will increase its stake to full ownership. The deal is expected to close mid-year.

Founded in 2012, Flatiron collects data from over 265 community cancer clinics, six academic research centers, and “14 of the top 15” therapeutic oncology companies. The company says it has two million active patient records that can be used for research.

In the real world, the term “real world evidence” (RWE) refers to the collection of data outside of a randomized clinical trial (RCT). An RCT is currently the preferred method for evaluating new pharma and device therapies. However, the weaknesses of clinical trials, such as small sample size, the challenges of patient recruitment and retention, expense, length of time to market and regulatory hurdles, are well known to those in the device and biotech industries.

There are benefits to collecting and analyzing data from electronic medical records. The sample sizes are larger, and the data represent real world outcomes experienced by patients and medical practices. More data means more reliable statistical modeling within the parameters of the analysis. Patterns in usage, side effects and condition-specific outcomes may emerge – relationships that may be missed in a clinical trial study.

In addition to Roche, other companies have developed initiatives utilizing real world data, including AstraZeneca (diabetes), Sanofi (diabetes), Pfizer and Bristol-Myers Squibb (stroke prevention), and Takeda Pharmaceutical (bowel disease).

Currently, the FDA appears to be favorably disposed to the use of RWE to potentially improve prescribing practices and lower development costs, as a result of the passage of the 21st Century Cures Act by the 114th U.S. Congress in late 2016. 

As with any game-changing technology, there are potential downsides as well. For patients, it raises the question of who owns their personal data. Patient privacy is another big concern, as corporations license access to records that previously were not available to them. Cybersecurity is an issue, as evidenced by the increasing rate of data breaches revealing lax digital security practices at hospitals, insurance companies and physician offices. And large volumes of data could increase the risk that a study will be built around multiple analyses searching for a specific, predetermined result.

Finally, control of access to a large scale RWE database confers a competitive advantage. It remains to be seen whether an independent entity will develop a scalable, company-agnostic RWE data source, or if large pharmaceutical providers will want to share RWE access with potential competitors. Stay tuned.