Table 5.

Initiatives for accelerating development of cancer prevention drugs

Biomarker, end point, and technology
    • Exploration of chemoprevention strategies based on understanding of genetic progression and biological processes associated with carcinogenesis
    • Efforts and policies to foster projects for development and validation of biomarkers in chemoprevention drug development and monitoring
    • Efforts/investment in risk-model creation, including data from new molecular methods, such as gene microarrays, proteomics, and nanotechnologies
    • Efforts/investment in precancer, IEN, both histologic and predysplastic as a significant part of the new NCI/NCGR Cancer Genome Project
Toxicology and regulatory guidance initiatives
    • Efforts/investment to develop new methods to evaluate and monitor toxicity, especially toxicities occurring with chronic administration of chemoprevention drugs
    • Development of regulatory guidance relevant to all aspects of chemoprevention drug development
    • Efforts/policies to gather postmarketing surveillance data of approved drugs
Structural changes to improve clinical trials
    • Augmentation of ongoing and future trials of molecularly targeted agents for cancer treatment by incorporating (nesting) studies to obtain data relevant to chemoprevention
    • Development of chemoprevention strategies to prevent cancer recurrence (i.e., using adjuvant settings)
    • Development of dedicated clinical research networks capable of translating knowledge of pathogenesis into meaningful clinical tests and interventions
Industry incentives
    • Exploration of strategies that would reduce the costs and hurdles for commercial development of chemoprevention drugs, including fostering industry collaboration on common problems, such as biomarkers, postmarketing toxicity data, new regulations on chemoprevention drugs, patent, and data package exclusivity
    • Encourage opportunities to accelerate progress in applied research and development of preventive vaccines
Multisector cooperation
    • Efforts/investment to establish PPPs with multiple government agencies, such as NIH/NCI, FDA, Centers for Medicare and Medicaid Services, and the pharmaceutical and biotech industries, as well as other stakeholders to foster team science, phase III trial prioritization, regulatory review, and education