‘End to end evidence management’ will affect both clinical and commercial activities
The second annual RWE Benchmarking Survey, from the ConvergeHealth unit of Deloitte, finds that 90% of global pharma companies either have, or are building, RWE analytical capabilities, and that applications range across the entire product life cycle for these undertakings. The most prominent application is as an adjunct to value-based contracting with payers, under which the reimbursement for a drug is tied to successful patient outcomes (something that 14 of the 20 companies polled are engaged in). Respondents indicate that analyzing “subpopulations and the heterogeneity of treatment effects” and understanding “the burden of disease” are the two most “impactful” areas of application currently; in the near future, “optimizing clinical trial design,” “supporting regulatory submissions,” and “design of value-based contracts” will sustain impact.
RWE, the “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of [real world data],” as FDA defines it, has been around for a long time in the form of observational or longitudinal patient studies. But the growing prevalence of electronic health records, combined with Big Data analytical techniques, is making it a much more valuable asset. According to the Deloitte study, analysts are charging ahead with adopting machine-learning techniques to manage the ever-larger datasets; there is also growing interest in analyzing social media, and data derived from wearable devices, to add to the mix.
A key milestone was reached early this year when Roche Group acquired Flatiron Health, a consultancy specializing in RWE analytics, for $2 billion; along the way, Flatiron’s analysis of Roche data enabled the firm to speed approval of one of its oncology products. Indeed, the strongest trend currently in RWE resources is companies building internal teams, staffed with data scientists and using advanced analytics and data-visualization tools (a business that ConvergeHealth is engaged in).
The report is available for download here.