In recent years, real-world data (RWD) has started to show its true strength as a way to gain deeper, broader, and more actionable insight into patients and their outcomes.
Buy-in from clinical trial experts, data companies, healthcare providers, and regulators like the FDA has made it easier and more attractive to start integrating RWD, and the resulting real-world evidence (RWE), into the drug development process.
Pharmaceutical companies are also keenly interested in taking advantage of everything that RWD has to offer – and despite the organizational inertia often present in large, multi-national enterprises, many pharma stakeholders are quickly moving to embrace RWD’s untapped potential.
How do we know? We asked them.
In partnership with Impatient Health, COTA conducted in-depth, semi-structured interviews with 20 high-level executive leaders from some of the most innovative pharma companies in the world, including Pfizer, Roche, Novartis, Sanofi, and Bristol Myers Squibb.
Nearly all of the executives believe that RWD has a critical role to play in the clinical trial environment and offers a way to “transcend and inform” pharma’s traditional functions while providing additional evidence around gold-standard randomized controlled trials (RCTs).
“In many ways catalyzed by the FDA’s updated RWD guidance, today we are seeing an increasing focus on effectively integrating RWD into the evidence generated by clinical trials, but also in implementing clinical trial participant feedback into the design of studies to improve the patient experience,” the report states.
“It is clear that RWD is an important element in informing functional strategic objectives and, in some cases, a future proofing strategy, especially in the development of patient-centered solutions. Across the board, leveraging traditional and non-traditional RWD is considered an important priority in order to achieve functional objectives.”
Opportunities abound for the use of RWD
Pharma leaders are excited to start using novel data sources, such as EHRs, patient-reported data, claims, and device data, as a more central part of their decision-making.
RWD provides a more comprehensive look into a patient’s holistic reality outside the tightly controlled RCT environment. Companies are interested in capturing new elements, for example, including data around the social determinants of health (SDOH), to better understand the interaction between their therapeutic agents and their patients’ everyday lives. Doing so will enable a new type of precision medicine and allow providers and pharma partners to continually improve the patient experience.
As the industry develops these capabilities, stakeholders are simultaneously exploring the value of synthetic data to test functional hypotheses, the use of AI and machine learning to extract meaningful insights from real-world data sets, and the implementation of popular healthcare data standards to improve the flow of data across systems.
The challenges of integrating RWD into the pharma ecosystem
While the opportunities are clear to pharma companies, there will still be challenges before they can reach their goals.
A major gap in skill availability will be a primary obstacle, the leaders noted. Data scientists with the right experience in RWD are hard to find and will only become more difficult to attract as competition heats up among potential employers.
Infrastructure and interoperability are another concern. The healthcare system is currently not set up to allow for the free flow of large datasets between disparate systems, which might be problematic when trying to scale the RWD environment. In addition, pharma companies often lack the internal capabilities to ingest and analyze large volumes of data in a coordinated, standardized manner.
Lastly, not everyone in the pharmaceutical community yet understands and internalizes the importance of RWD and RWE for developing the next generation of therapies. Many leaders expressed frustration while championing the development of a data-driven culture, noting that it would take time and persistence to educate and engage their colleagues.
A bright future for RWD in the drug development pipeline
Even though there are challenges ahead, pharma companies are investing heavily in overcoming these obstacles.
To see success, companies will need to commit to fostering a data-driven culture throughout the enterprise with an emphasis on creating a standards-based single source of truth for their RWD activities.
By setting up a strong technical foundation and championing the business cases for RWD and RWE, companies will be able to innovate and explore as RWD becomes more deeply integrated into the clinical discovery process.
“Because we are in the early days of integrating RWD into new drug submissions, some leaders stated that this presented a good opportunity to begin testing and validating new processes and frameworks that will help drive insights from RWD across functions before RWD becomes instilled with poor practice,” the report concludes.
“There are good opportunities to start engaging in agenda-setting discussions with decision-makers, especially around informing industry-wide data standards. With the enhanced awareness of the importance of RWD, we will likely see an exponential increase in new technologies and innovations.”