HealthCore looks forward to the potential, positive impact that real-world evidence may have on regulatory decision making and therapeutics development within the U.S.

We believe pragmatic trials will be a large part of the future of outcomes research – to understanding life science products in real-world settings, evaluating comparative effectiveness and helping to improve patient care.

Pragmatic clinical trials provide the optimal environment to address a broad spectrum of real-world issues, and generate evidence synergistic and complementary to RCTs. For clinicians, pragmatic trials generate evidence that enables better-informed decision making.

Under certain circumstances, opening up the design options in the pre-approval phases of drug development to include Pragmatic Clinical Trials (PCT’s) has the potential to greatly enrich and complement the findings from traditional RCT’s and, earlier in the drug approval process, broaden the generation of evidence more relevant to treated patients.

Large-scale alliance collaborations present a massive opportunity for stakeholders to work together to inform the decisions that have the power to make healthcare safer, lower cost, and higher quality.