The pharmaceutical industry is witnessing significant developments in the integration of real-world data (RWD) and real-world evidence (RWE) into regulatory processes, as indicative trends shape future business practices. In December 2024, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) made a pivotal announcement with the creation of a new Centre for Real-World Evidence Innovation. This centre aims to enhance the usage of RWD and RWE in regulatory decision-making, which has become a focal point for pharmaceutical regulators in recent years.
As part of this initiative, the FDA has published various guidance documents addressing the use of real-world data during 2023 and 2024. These documents provide frameworks for pharmaceutical companies to better understand how to utilise RWD in their submissions, thereby seeking to facilitate a more efficient regulatory process. The European Medicines Agency (EMA) is concurrently engaged in efforts to promote the use of RWD and RWE in similar capacities, indicating a broader shift in the global regulatory landscape.
To gain insight into these evolving trends, Pharmaceutical Technology® engaged in a dialogue with Sujay Jadhav, the CEO of Verana Health. Jadhav highlighted a significant transformation in clinical research methodologies, stating, “We're seeing exponential changes in both of those particular components,” regarding RWD and RWE. He elaborated that external control arms are becoming increasingly mainstream within clinical trials, a shift largely influenced by the recent guidance from the FDA aimed at facilitating the incorporation of real-world data into the drug discovery process. He further noted, “This is an incredible source to help improve sort of efficiency and the quality of our research overall.”
Moreover, Jadhav identified predictive analytics and artificial intelligence (AI) as emerging trends poised to revolutionise the industry. He explained, “AI and these technologies, they can identify trends for data, [and lead to] informed decisions across the drug life cycle,” underscoring the potential of these advancements in predicting disease progression and enhancing patient recruitment and retention.
These transformations in RWD utilisation and AI integration are expected to influence not only regulatory practices but also the overall efficiency and effectiveness of pharmaceutical research and development efforts, setting a course for the future of the industry in the coming years.
Source: Noah Wire Services