Historically, patients enrolled in clinical trials are generally younger, healthier and less demographically diverse than patients in the real world which makes it challenging to extrapolate the results of a clinical trial to the broader patient population. Furthermore, only a small percentage of cancer patients ever participate in clinical trials. To address these challenges, the FDA in recent years has taken steps to address and encourage diversity in clinical trials. Additionally, sponsors have also started to explore alternate, more flexible trial designs such as decentralized or virtual trials.
Real-world data (RWD) and real-world evidence (RWE) can provide insight on how treatments are actually working in underrepresented populations. It can help researchers understand how therapies are applied in patient care, and evaluate their performance in populations that may not have been represented in the initial trials and in a post approval setting.
During this webinar, panelists will discuss:
- Inclusive trial design
- Clinical trial recruitment and communication with would-be participants
- Eliminating barriers with decentralized clinical trials
- Regulatory guidance
- Using RWE to assess whether RCT findings apply to patients in the real world
- Surfacing new insights about diverse populations through RWD