Summary of Responses: Factorial
Industry concerns
- drug interactions
- overlapping toxicities
- timely availability of drug supply
- ownership of IND and data
Community and FDA in favor of this approach
- industry concerns valid but not insurmountable
- factorial design can be modified
- randomized trial that participants are more likely to complete
- expenses for one trial shared by two or more companies
- blinding and provision of placebos easier