2021: The Year of Real-World Data

On almost every front, 2020 was a year of seismic change. The pandemic upended our realities and routines, requiring us to experiment and adapt in ways that will have long-lasting, if not permanent, effects. The pandemic has specifically accelerated the pace of innovation in the realm of real-world data, fueling a number of trends that we expect will carry on and pick up steam post-COVID:

1. More collaboration leads to faster innovation

In surprising and often heartening ways, the pandemic broke down silos, sparked new conversations, and demanded a more open and intentional focus on data-sharing across the industry. The COVID-19 Evidence Accelerator, an FDA-backed initiative COTA has actively contributed to, was a shining example of how the pooling of RWD across a broadened community of researchers and data holders can speed learning cycles and advance discovery and treatment.

2. Increased opportunity for real-world data to improve patient outcomes

With in-person care and clinical trials disrupted, RWD stepped in to bridge the gap and prove its value in complementing trial-based research. As Novartis’s head of data and digital Bruno Villetelle summarized in a recent COTA podcast, RWD offers traditional drug development programs the critical opportunity to “accelerate timelines, reduce clinical trial costs, and increase the probability of success.”

3. An uptick in demand for observational studies

As we’ve seen with COVID-19 vaccine development, the urgency of the pandemic has compressed research timelines, leaning more than ever on RWD and observational studies to speed the generation of medical insights. For example, RWD has been called upon to evaluate and validate clinical trial findings and provide a deeper understanding of how various risk factors affect outcomes for COVID patients. Such RWD studies are of particular importance for refining our knowledge of the complex interplay of COVID-19 and cancer as we work to get cancer detection and treatment back on track in the months and years ahead.

4. Addressing diversity and inclusion issues in clinical trials

Finally, the events of the past year – from the pandemic’s tragic inequities to the Black Lives Matter protests – have inspired a deep reckoning with issues of diversity and representation in clinical research. As called out in the FDA’s new guidelines for making clinical trials more equitable, RWD offers an important tool to examine, expose, and correct inherent biases in past and current research.

With these and other tailwinds at our backs, we at COTA begin 2021 with a shared commitment to learn from the successes and failures of the past year, a renewed sense of purpose, and a determination to fully harness the power and potential of real-world data to improve lives.