The strategic application of real-world data (RWD) is emerging as a critical factor in averting the collapse of early-phase oncology trials, particularly in the rapidly expanding non-small cell lung cancer (NSCLC) treatment landscape. With the NSCLC market projected to grow by over 40% by the end of the decade, competition for patients in clinical trials is intensifying, making efficient trial design and execution paramount.
Overcoming Recruitment Hurdles in NSCLC Trials
Ophelia Chan of GlobalData highlighted at the 11th Annual Clinical Trials in Oncology conference in Munich that Phase I and II trials face the greatest challenges in patient recruitment. An analysis of the current oncology trial landscape reveals approximately 4400 ongoing NSCLC trials, with an additional 27 drugs in the pre-registration phase. While Japan and China have the highest NSCLC diagnosis rates, the majority of trials are conducted in the US, potentially creating opportunities in underserved regions like Japan, the UK, and Italy.
Chan emphasized that low recruitment rates were a primary driver of NSCLC trial failures in 2019. "There could be possible gaps in our patient access or engagement programmes which could be addressed through a targeted outreach programme or through decentralised trials," she stated. This suggests that a more patient-centric approach, leveraging RWD to identify and engage potential participants, is essential for improving trial success rates.
Biomarker-Driven Enrollment and Decentralized Trials
Targeting patients with specific biomarkers can significantly streamline enrollment processes, increase overall efficacy rates, and shorten trial durations. Biomarkers can also aid in identifying susceptibility to specific adverse events, enabling more targeted patient monitoring. This precision medicine approach, guided by RWD, can optimize trial design and improve patient outcomes.
Furthermore, the adoption of decentralized trials is crucial for reducing patient burden and maintaining engagement. By minimizing the need for frequent site visits and incorporating remote monitoring technologies, decentralized trials can improve patient retention and data quality. This approach is particularly relevant in NSCLC, where patients may face significant challenges in accessing traditional trial sites.
Regional Opportunities in NSCLC Trials
Chan noted that most ongoing and planned NSCLC trials are currently in Phase I/II, with the US and China leading in recruitment and planning. In contrast, Italy, the UK, and Japan have fewer trials, indicating potentially less competition for patients. This regional disparity presents an opportunity for sponsors to consider conducting trials in these underserved markets, where recruitment may be more efficient.
By combining the strategic use of RWD, biomarker-driven enrollment, and decentralized trial designs, sponsors can overcome recruitment challenges, improve trial efficiency, and ultimately accelerate the development of new therapies for NSCLC.
