During a speech at Cleveland clinic to some of the industry's leading decision makers he proposed his peers in establishing a health care "Information Revolution."
"The use of prescription medicines always will be a matter of balancing benefits and risks," Taurel said. "Fortunately, systems are now within our grasp to more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use."
Although traditional drug trials will continue to test new hypotheses about medicines after they have reached the market, Taurel outlined how a well-functioning health IT system could serve not only to frame hypothesis for so-called "Phase IV" clinical research, but also become the practical equivalent of massive, real-world trials.
The system would be able to collect detailed data from day-to-day medical practices and feed insights quickly, seamlessly and cheaper to doctors, regulators, and drug manufacturers.
Taurel also explained that intent of the newly enacted FDA Amendments Act of 2007 is to promote much wider involvement of health plans, academic medical centers and other sponsors in Phase IV research.
"The time is ripe for FDA, the health care industry, and the medical community to collaborate on a reform of our nation's pharmacovigilance system," said Taurel. "Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly."
Taurel noted that to fully realize a better drug safety system would require the large-scale implementation of Electronic Medical Records (EMRs) - patient-specific repositories of clinical information on diagnoses, treatments, and outcomes. Healthcare analysts said the information could be properly "blinded" to ensure patient privacy. The information database outlined could also include genetic information as in order to tailor therapies to patient groups that work effectively.
