Real-world data (RWD), or clinical data derived outside of traditional clinical trials, and resulting real-world evidence (RWE) are increasingly being used to drive innovation across the healthcare industry. The impact of this data is being seen in everything from clinical development to regulatory decision-making to pricing and access to healthcare delivery. The excitement surrounding RWD is equally palpable and seen everywhere from scientific conferences to Silicon Valley’s VCs’ conference rooms. This trend looks to have a long trajectory as well, especially given the FDA’s recent focus on creating standards for and encouraging the use of RWE for regulatory decision-making (see here), and the proliferation of new technology platforms, such as Aetion and Roam Analytics, that make RWD more accessible to various industry professionals.
W2O recently entered into a licensing agreement for full access to medical claims, pharmacy claims and electronic health record data for over 300 million (anonymous) patients in the U.S. Because we take data privacy seriously, it’s important to note that this licensed data is completely de-identified and fully compliant with HIPAA privacy and security rules. When we combine claims and EHR data with other forms of non-traditional RWD that we use, such as social media data, mobile data and search/web data, we find incredible high-resolution views into the clinical landscape. This helps us and our clients better understand why what we see in the lab or in controlled experiments doesn’t always match reality in the real world (big reveal: not all patients and providers make optimal decisions based on the literature, and they are as susceptible to cognitive biases as you would see in any other industry). More importantly, this 360-degree view of the patient population and their care providers gives us much clearer direction on how we, as an agency, can help our clients improve clinical decision-making, patient access and health outcomes.
The commercial applications for RWD and RWE are more established than those for clinical development and regulatory decision-making, and some might even find it surprising that a marketing and communications agency, such as W2O, would use this data across its clients’ commercial activities. But, as former FDA Commissioner Scott Gottlieb has repeatedly discussed, RWD provides a crucial missing link between clinical trials and clinical care. By bridging that gap, we’re quickly modernizing how new therapies are brought to market. Specifically, we can now create models of the provider and patient populations that will most benefit from new therapies and procedures using RWD, rooted in clinical trial results, that is far more accurate and actionable than traditional market research could ever be. The fact that commercial, medical and scientific teams can all speak the same data language now is a sea change for medical marketers and communicators, who have just been propelled from a 20th century world of surveys and qualitative interviews to one that looks much more like consumer technology companies, which are successfully using the same first-party data for everything from product development to digital advertising.
We’re just beginning to scratch the surface of how RWD is useful across a broad range of medical and commercial activities. Following are a few ways we and our clients are using RWD today:
- Clinical trial design: Identifying patient markers in RWD that predict clinical response and adherence, and selecting appropriate outcome measures
- Clinical trial recruitment: Identifying eligible patient populations, particularly for rare diseases, more quickly so clinical trials are more cost-effective and new therapies can be brought to market more quickly
- Market intelligence: Understanding gaps between clinical trial efficacy and actual real-world effectiveness for long-existing therapies, including why patients don’t respond to therapies as expected and other issues that affect broad adoption or adherence
- Audience segmentation: Identifying groups of providers and patients that are high priorities from a communications and education perspective, given their clinical practices, social determinants and unique patient journeys
- Media planning: Using machine learning to predict clinical practices and preferences given providers’ medical education preferences and media consumption habits
- Pricing and access: Demonstrating the value and cost of new therapies and indications to the healthcare system
- Campaign optimization: Continuously testing whether our pre-launch and post-launch marketing activities are having a positive impact on clinical practices and patient outcomes
Again, we’re just beginning to realize the full potential of RWD applications for communications and marketing. But, even in these early days, it’s clear that we’re quickly advancing from a data dark-age in pharma marketing to one where we’re able to bring innovative new therapies to the market faster and more effectively.