Abstract IA008: How to move a preventative agent from design into approval


 Cancer prevention is a global public health challenge that requires a multidisciplinary approach including biology, epidemiology, medicine, nutrition, education, clinical trials and public policy. An intent-to-treat analysis of a randomized controlled trial differs from that in the observational setting, therefore, it is important to understand the underlying disease process and aspects of the intervention through research. The genetic heterogeneity of some cancers strongly support an enhanced focus on prevention as a strategy in high-risk individuals. Important factors when developing preventative cancer agents include the time course of the intervention, dose and duration of exposure needed to effect risk reduction, trial endpoints, durability of the impact of intervention, and methodological problems in implementing and interpreting randomized trials to evaluate prevention strategies. The clinical development of cancer prevention therapeutics has many challenges, including the long duration necessary to conduct trials, the lack of adherence to therapy, and unanswered questions on the best endpoint remain. The government, whether it be local, state or national, plays a vital role in regulation and education. The history of chemoprevention regulatory approvals has taught us that these programs are important in the fight against cancer. The Food and Drug Administration has identified barriers to clinical trial participation and challenges in surrogate endpoints, although with a multidisciplinary approach including communication with industry, are extremely positive about the future direction of chemoprevention research.
 Citation Format: Danielle Krol. How to move a preventative agent from design into approval [abstract]. In: Proceedings of the Second Biennial NCI Meeting: Translational Advances in Cancer Prevention Agent Development (TACPAD); 2022 Sep 7-9. Philadelphia (PA): AACR; Can Prev Res 2022;15(12 Suppl_2): Abstract nr IA008.