An RWE Center of Excellence (CoE) can prevent duplication of data purchasing and reduces the risk of analyses producing different results. In comparison, a medical affairs or HEOR-led RWE function can improve the overall quality of RWE generation.
In companies where medical or HEOR lead RWE generation, medical leaders can identify customer questions to evaluate, and use their expertise to shape the methods used to analyze RWD. Medical leaders can also work upstream by providing insight into regulatory considerations and advocating for RWE use early in the product lifecycle. Medical leader expertise can add value that a consultancy-style Center of Excellence organizational model might lack.
Most attendees noted that their RWE capabilities are housed within their medical affairs or health economics and outcomes research (HEOR) functions. While some attendees identified the CoE model as their organizational goal, others felt that keeping RWE in medical affairs or HEOR enables them to shape RWE generation more effectively. Only a few large pharmaceutical companies have created an above-brand RWE Center of Excellence.
Regardless of the organizational model used, there are five elements every best-in-class RWE organization must have. However, most medical leaders told us they are still in the early stages of developing the following five elements of their RWE organization:
- Formalized processes for cross-functional alignment on RWE use: Regular discussions between R&D, HEOR, medical, regulatory, commercial allow teams to share how they are using RWE and promote increased use of RWE. However, most companies today (60% of medical leaders surveyed) lack a formalized process for cross-functional RWE engagement. Developing a cross-functional RWE strategy requires high-level vision and leadership buy-in for RWE, but increasing alignment can be as easy as monthly meetings to review RWE strategy and share RWE status updates.
- Streamlined processes for acquiring and maintaining real-world datasets: 80% of medical leaders surveyed do not have this capability at their organization today, and struggle to understand what data is available to them. While an RWE Center of Excellence may help companies overcome this challenge by streamlining data management at the enterprise level, few organizations have this model. As a result, medical leaders should look for other ways to routinely identify and access data for their teams or therapeutic areas.
- Pre-determined metrics for success (including, but not limited to, regulatory approvals or value-based contracts): No organizations (0% of medical leaders surveyed) have determined the right set of metrics to measure RWE’s value and impact. Today, RWE’s success is often measured by regulatory or commercial wins (e.g. label expansions, new approvals, new value-based contracts with payers). However, those wins are infrequent – and RWE can provide a broad range of value beyond such use cases. Medical leaders must identify ways to quantify the value of RWE, while recognizing the broad value it can provide in non-quantifiable circumstances (e.g. informing patient choice, demonstrating patient adherence).
- Field staff trained to communicate RWE with customers and anticipate sources of concern: Only 40% of medical leaders surveyed have field staff that understand and are equipped to discuss RWE today. Medical leaders must invest in training to help field teams understand the difference between RCTs and RWE, how different customers (beyond payers) use RWE, and how to identify unsolicited questions that aren’t answered through RCT.
- Frequent internal education and training sessions to raise awareness of RWE studies and capabilities: Only 20% of medical leaders surveyed have company-wide initiatives to educate colleagues about RWE. However, even small-scale efforts like RWE lunch-and-learns and RWE Q&A sessions can demonstrate the value of RWE to cross-functional colleagues and raise internal awareness.
For more research on real-world evidence check out our Real-World Evidence Resource Center.