Download or read book Investing in Clinical Trials for Older Adults written by Woojung Lee and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Conducting clinical trials for older adults can address the long-standing issue of the underrepresentation of older adults and the lack of clinical evidence for them. Examining the challenges and the value of such trials could facilitate discussion among trial sponsors on the investment in and the prioritization of older adult-specific trials. This dissertation examines the risk of failure and the real-world value of older adult-specific clinical trials. In Chapter 1, we developed a model that predicts the risk of failure of older adult-specific cancer clinical trials, using trial-level factors. The best-performing machine learning model had an acceptable performance and included nine trial-level factors that can be measured using the trial protocol. The model can aid in the design and prioritization of future older adult-specific clinical trials. Future works examining the causal relationship between the important factors the trial failure can help develop strategies to reduce the risk of failure of cancer trials for older adults. In Chapter 2, we estimated the impact of cumulative evidence from older adult-specific trials on the prescribing patterns, using phase 3 clinical trials for post-lumpectomy irradiation in early-stage breast cancer (ESBC) as a case study. The difference-in-differences analysis showed that older adult-specific trial results led to a significant decrease in irradiation use over time among older adults and the rate of decrease was significantly accelerated by longer-term follow-up results. These findings confirm the potential of new evidence for older adults to make a substantial change in providers’ prescription patterns and the importance of evidence accumulation in driving their behavioral change. Chapter 3 builds on this analysis to quantify the downstream clinical and economic benefits of older adult-specific trial results, using a health-transition model. We found that the older adult-specific trial results on the post-lumpectomy irradiation in ESBC resulted in a substantial cost-saving in the US society, without significantly changing clinical outcomes. These results can inform the discussion around whether to invest in older adult-specific clinical trials. More case studies for trials with different types of results are warranted to have a more comprehensive understanding of how different types of older adult-specific trials generate value.