Leveraging Real World Data (RWD) for Better Clinical Trials

Presenters: James T. LaPointe, Managing Director of Life Sciences & Healthcare, Cambridge Semantics and Jeffrey S. Barrett, Vice President for Translational Informatics, Sanofi Pharmaceutical Company

Originally recorded May 18, 2017

Well designed and well conducted clinical trials are essential for every successful biopharmaceutical company to prove the efficacy and safety of their investigative products. These trials are typically designed based on similar prior trials or Clinical Trial Simulations (CTS) using assumed patient demographic and health profiles. Trials designed using these techniques may not accurately reflect actual patient populations leading to trial recruitment difficulties, erroneous trial outcomes or unexpected post-approval therapy performance.

Electronic Medical Records (EMR) provide a tremendous opportunity for biopharmaceutical companies to leverage patient-centric, longitudinal Real World Data (RWD) or Real World Evidence (RWE) to better understand their therapy targets and provide fact-based CTS assumptions leading to better informed clinical trial designs. However, RWD are often difficult to harmonize with clinical trial data constructs and often exceed the scale of most advanced analytics platforms.

A new and novel approach, based on the Cambridge Semantics Anzo Smart Data Lake (ASDL) graph-based technology, was piloted to demonstrate the feasibility of leveraging RWD to inform CTS. The outcomes and methods of that pilot program are discussed during this webinar.

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