Accelerating Clinical Trials Through Access to Real-World Patient Data

The pharmaceutical and life sciences industry needs to accelerate clinical research to reduce overall R&D costs while delivering innovative treatments.¹ However, virtually all pharmaceutical manufacturers and contract research organizations (CROs) recognize that accessing the needed quantity and quality of real-world patient data is a fundamental barrier to reaching this goal. Escalating costs and delays in clinical trials for new drugs and treatments remains the norm.

Easier access to and sharing of real-world data across healthcare organizations, communities, and countries is the solution. But how do you move an industry conditioned to working with highly structured, consolidated data repositories into the unstructured, decentralized, and often chaotic realm of real-world clinical data?

The answer is to provide the clinical trials ecosystem with a foundational health informatics platform that enables researchers to access and use real-world data from hospitals and other healthcare providers. Such a platform and complementary solutions are needed to navigate and normalize the various federated networks being put in place. With a health informatics platform, clinical researchers can more quickly evaluate protocol feasibility, identify and recruit viable patient candidates for trials, and track patients enrolled in clinical trials. Once a drug or treatment is on the market, the platform enables efficient and accurate health surveillance and observational studies using real-world data originating from many different sources.
 

^{1 “Integrating New Approaches for Clinical Development: Translational Research and Relative Effectiveness,” by Jean-Pierre Lehner, Robert S. Epstein, and Tehseen Salimi. Journal of Comparative Effectiveness Research, Vol. 1, Issue 1s, 2012.}