Chris Pashos discusses the evolution of real-world evidence and argues that although more data sources are beneficial, their fitness-for-purpose remains crucial.
By Chris Pashos
New data sources
The real-world evidence (RWE) space has changed considerably since Genesis Research Group was established more than a decade ago. This revolution has been driven in part by the availability of more types of data, greater ability to link different data streams, and advancements in analytics, including greater use of artificial intelligence and machine learning.
With those advancements have come an increase in use cases, as RWE studies can now answer a more diverse set of questions, thereby enabling life sciences companies to better inform both their development and commercialization activities in a comprehensive and integrated manner. From primarily cost analyses using claims data, RWE generation has exploded with more types of data becoming more available, including regulatory grade electronic health records (EHR) data and clinical genomics data, as well as patient-reported outcomes and wearables data. In fact, it seems that each year there are new sources of data from which to gather insights to understand diseases, treatments, and outcomes, and to incorporate them into decision-making processes across the biopharmaceutical industry.
Since its inception in the arena of real-world evidence strategy, Genesis Research Group has observed and indeed participated in this evolution of real-world data (RWD) and RWE. Whereas the cost analyses using claims data were typically executed with and on behalf of health economics and outcomes research and market access departments within the life science companies, today different departments recognize the value of RWD to answer critical questions related to their specific responsibilities within the development and commercialization process of new treatments as well as diagnostic modalities. This has been driven both by greater recognition of how valuable RWE is in contributing to more efficiently designed clinical development and commercialization programs and specific studies, and by the external motivation provided by regulators, Health Technology Assessment (HTA) authorities, and medical health care providers, who are using RWE in their own decision-making.
Fitness-for-purpose
This increased number of use case types for RWE has fortunately led to greater emphasis on fitness for purpose of the different type of data and of the different data sources. Certain data, for example, may well be appropriate for supporting the commercial aspects involved in highlighting market opportunities, but unsuitable for strengthening the design of a clinical trial or providing supporting data on unmet need to an HTA. As specialists in the field, Genesis Research Group understands how to assess the strengths and limitations of a particular data source for a specific use case, and how to craft an RWE program that takes advantage of the respective strengths of different data, while mitigating their limitations. This allows Genesis Research Group to confidently partner with different departments in a biopharmaceutical company to help them meet their objectives across the product life cycle.
This strategic awareness of alternative data sources and recognition of fitness-for-purpose is strengthened by the Genesis Research Group data agnostic approach to RWE. When offering real-world evidence services, Genesis Research Group starts with the end in mind, identifying what data are needed, locating the best combination of data sources to meet objectives, and then advising our clients accordingly.
This way of working has been strengthened recently with the use of the innovative Genesis Research Group EVA platform (a subset of our Integrated Evidence Planning platforms). Standing for “evidence, value, access”, the EVA platform was primarily created to support a company determination of the comprehensive value of its product relative to others. Because that value – and the relevant supporting data – extend beyond RWE, EVA contains relevant evidence generated from clinical trials, as well as from RWE, and supports an integrated approach. In fact, this allows EVA to help in the planning and communication across departments of the product’s integrated evidence strategy. Through EVA, the product’s value can be communicated in a seamless, easy-to-understand way. As more evidence from clinical trials and real-world studies is accumulated – from global, regional, or country-specific sources, EVA is updated and provides a company-wide source of common knowledge to be communicated internally and, as appropriate, externally to key stakeholders, including HTAs, payers and medical providers.
In summary, RWE has become key to decision-making, both internally within life sciences companies and among the external stakeholders, including regulators, HTAs and payers, and the medical community. RWD needs to be fit-for-purpose to generate robust RWE that will be considered by those decision makers. Appropriately used RWD and rigorously generated RWE give life science companies the best opportunity to succeed in their clinical development and commercialization programs.
If you would like to find out more about Genesis Research Group’s real-world evidence services, please contact solutions@genesisrg.com.
BY: Chris Pashos, Board Member, Genesis Research Group
