Episode 6: Real-World Data in Clinical Trials: Overcoming Challenges to Realize Value

Sunil Agarwal is the Principal and Head of Clinical Excellence Practice at Axtria. He leads digital transformation and improvement programs for top pharma companies. Jasmeet and Sunil discuss how patients can be served better by including real-world data in clinical trials and research. Real-world data is not a replacement for traditional trials, but it is helping drive the future evolution and innovation in our industry. The goal is to save lives and provide better patient outcomes. Don’t miss this thought-provoking episode.

In This Episode, We Cover:

• [2:50] Sunil explains the challenges with randomized control trials and why we need to leverage real-world data 
• [4:48] Sunil expands on how collecting environmental location or contextual data could lead to insights such as the correlation between activity and health changes
• [6:00] Sunil gives examples of cases using real-world data
• [9:16] Sunil outlines challenges faced, for example, the quality of the data collected
• [12:06] ​​Sunil expands on the regulatory considerations for using real-world data in clinical trials 
• [14:43] Sunil shares a couple of the innovations and unique approaches that he is bringing to customers

Key Takeaways:

• There is a lot of potential to effectively use all types of real-world data for clinical trials, even though it has its own set of challenges, such as data quality, privacy, and bias, and there is an emerging need for data-driven and digital solutions to utilize real-world data and minimize its limitations.
• There is a wider availability and increasing acceptability of real-world data among global regulatory bodies when companies follow key regulatory considerations.
• To ensure successful and cost-effective use of real-world data for clinical trials, companies need a set of capabilities and some enablers, which include data science and engineering, domain expertise, ethical considerations, and support from regulatory agencies.