While healthcare is rapidly adapting to the digital era, the basic systems and processes for conducting clinical studies to assess new medical treatments are still based on the legacy of a separate, paper-based, parallel process. These legacy systems are mired in collecting data on CRFs and distilling them into datasets that bear little resemblance to primary healthcare data.
Given the priorities of the FDA to incorporate real-world evidence from EHRs, coupled with the industry pressure to reduce cost and time to market while improving care, the methods and tools for collecting, representing and using clinical trial data and monitoring drug safety are stale and outdated, if not moribund.
This presentation will examine the current state of research data and discuss a provocative set of critical trends, opportunities and challenges directing future change.
Use real-world evidence from healthcare to inform program and trial design, support pragmatic and other research trials and improve Pharmacovigilance and regulatory review
Recognize the use of FHIR to improve the clinical trial data collection process from clinical sites and patients
Discuss how SMART on FHIR can bring more patients and patient data to research and improve availability of research data to patients