Modernizing the Pharmaceutical Development Process with Electronic Health Records (EHRs)
Creating new value
The pharmaceutical industry is currently facing challenges on multiple fronts. Ongoing expiry of blockbuster patents and increasing price pressure from payers are resulting in an increasing market share for generic pharmaceuticals. To combat these pressures, the industry has allocated more funding to research and development (R&D). Despite this increase in spending, pipelines remain weak and many of the major firms will be unable to replace the revenue from expiring patents.
Increasing regulatory scrutiny compounds the challenges presented by weak pipelines as it now costs more and takes longer to bring a product to market. In order to provide the level of data demanded by the FDA and other regulatory bodies, clinical trials are becoming more complex and are taking longer to complete. Faced with declining revenues, companies are being forced to cut costs across the organization. Within development, they are investigating solutions to shorten trial cycle times and decrease costs while still satisfying the stringent regulatory requirements. As a result, there is a greater focus on improvements within trial design, patient and investigator recruitment, and trial execution and data analysis.
Creating new value for shareholders will increasingly hinge on Life Sciences companies readiness and competency in accessing and exploiting massive and disparate data sets to drive new paradigms in discovery, development, marketing and surveillance.
While Electronic Health Record (EHR) systems are far from universal, the potential held within this vast repository of data has the ability to revolutionize traditional clinical development. Clinical development organizations can leverage patient data to improve clinical trial design, speed patient and investigator recruitment, and improve the efficiency of trial execution and data analysis. Though market limitations limit the immediate potential, the appropriate investments can position pharmaceutical companies for future success and can return incremental near-term benefits.
This article will help you think through ways to effectively apply EHR data to inform decisions during clinical development. Download the full article below.