The FDA designs its pilot program to encourage the use of Complex Innovative Trial Designs, particularly in areas with small patient populations or unmet needs to ensure greater collaboration during the design process of more novel and efficient clinical trials.
CIDs require upfront planning and communication with the regulatory bodies and rigor in preparation and execution, including addressing DMC requirements.
CIDs’ complexity comes from implementation of complex statistical methodology. In most cases these designs are simulation-guided, i.e. extensive simulations are needed to optimize the design parameters (sample size, number and timing of interim analyses, interim decision making, etc.) and to establish operating characteristics of the design (type-1 error and power).
Partner with our experts to deliver a CID that fits your needs.
Our expert statistical and clinical advisors provide:
300+
studies designed
130+
Innovative Designs including Adaptive and
30+ Bayesian
100+
interactions with health authorities (EMA, FDA, MHRA, GBA, PMDA) & strong experience in Regulatory Statistics
Integrated team of clinicians, regulatory consultants and statisticians
