Call to action: Embedding RWD/E use across the enterprise
This year’s survey results suggest a continued evolution of RWD/E within the biopharma industry. There are several key principles that companies can pursue to further expand their RWE capabilities:
Set an enterprisewide strategy. Developing an enterprisewide strategy could help change how companies utilize RWD/E. For those organizations that already have a strategy in place, it should be revisited frequently, given how quickly this area is evolving.
Continue to invest. In our last survey, we saw that the companies that invested early were starting to see returns on those investments. With the pace at which technology is evolving, new sources of data, demand for talent, and continued investments also will be key to taking an organization’s RWE capability to the next level.
Integrate RWE into processes. While expanding the use of RWE across the organization, it is important to embed it in the relevant processes wherever possible, making it a standard part of the ways of working within the organization. IEP is a great example of embedding RWE into an asset’s evidence planning process.
Govern for the enterprise. This year’s survey results show organizations have defined processes for RWE study design and dissemination of results. However, embedding RWE use across the drug life cycle requires enterprise governance to ensure that stakeholders have frictionless access to data for the right purpose.
As AI-enabled RWE generation grows, it’ll become crucial to define governance to manage the ethical risks associated with AI use. Ensuring AI models are built with a thorough understanding of the disease and patient population being studied can improve the fairness of outputs and avoid biases toward certain subgroups. Algorithm validation should check training data to ensure its representativeness and correct biases that may reflect outputs. Human decision-makers should be given the discretion to override model decisions to promote ethical decision-making.
Be bold and agile. As RWE becomes a critical organizational capability, leaders should encourage teams to experiment with RWD/E to challenge orthodoxies within their companies. For instance, in R&D, leaders could encourage development teams to explore using RWD/E in drug development programs and present ideas at stage-gate meetings. Allowing teams to experiment, gain hands-on experience, learn, and iterate with RWD/E could create an environment that encourages innovation and sparks new ways of working.
As RWE becomes a key future capability, now is the time for organizations to consider steps to embed its use more extensively across the enterprise. Organizations that do so are likely to emerge as leaders and differentiate themselves as they win with RWE as an end-to-end capability.