The healthcare landscape continues to evolve towards a technology-enabled, data and outcomes driven environment, anxiously focused on the possibilities available through Real World Evidence (RWE). While RWE is not a new concept, its ability to influence decision making across healthcare has increased significantly with the greater availability and access to real world data (RWD) sources.
Creating a comprehensive RWE strategy is becoming a necessity for life science companies in order to not only organize and utilize the many RWD options available today, but also to build an evidence repository for engaging key stakeholders.
As well documented, the markets in which life science companies operate are dynamic. Numerous complexities exist in scientific, regulatory, patient-based, operational, market access, competitive and lifecycle realms that need to be accounted for in the development of a successful research and commercialization plan. It’s within this context that comprehensive RWE strategy should be developed to support the overall commercial objectives of a product. With RWE having the potential to change the course of both development and commercialization of life science products, it’s critical to undertake a comprehensive approach, starting early in the product lifecycle and revisiting at key milestones to ensure that the RWE requirements are updated at regular intervals. Adjusting to changes in the dynamic context in which life science products make their way to market is critical.
Building a comprehensive RWE strategy today requires an integrated cross functional team. Several disciplines across the life science enterprise are involved with either RWD or RWE directly or are needed for its successful deployment. The list includes Epidemiology, Feasibility, Data Analytics, Health Economics, Outcomes Research, Late Phase Operations, Market Access, Marketing, Patient Engagement, Regulatory and Medical Affairs as the primary functions (figure 1). Central to all of this is the core RWE team which many progressive life science companies have taken steps to define and build out. Utilizing this cross functional model combines expertise from each discipline and ensures a more complete overall perspective around the evolving requirements and value of RWE for each set of healthcare stakeholders: regulators, payers, patients, and providers.
Once the right integrated team is in place, the focus shifts to RWE strategy development. Critical to this process is first ensuring the commercial objectives for the product or broader portfolio under consideration are clearly understood by all members of the cross functional team. Best practices here suggest that by working through a set of key steps (figure 2), starting with the product’s commercial objectives, and then followed by a thorough situational assessment of the disease state and competitive landscape for relevant geographic markets, leads to the identification of the opportunities and challenges that will gate success. The next step is critical for planning how various RWE options can address the opportunities and challenges in a way that will deliver on the commercial objectives. And finally, armed with a comprehensive RWE strategy, it comes down to the most important step: execution of the plan through various traditional and innovative RWE study types.
Undertaking this approach can be daunting within life science organizations that are still in the early stages of defining their comprehensive RWE strategy. Working with partners who already support a fully integrated, multidisciplinary model can save time, money and effort during both strategy development and study execution phases leading to the best commercial outcomes.
Jim Carroll is vice president of Real World Evidence at ICON plc.