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Abstract:
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Properly structured regulatory guidance can encourage the use of novel approaches, such as Bayesian paradigms and methodologies, which offer potential efficiencies and/or improved risk-based decision metrics. Regulatory innovations in the clinical trial space are bearing fruit and early phases of nonclinical development face limited barriers to the use of Bayesian methods. However, significant regulatory interaction in CMC spaces has the potential to limit the use of Bayesian methodologies that might otherwise lead to better decision making. CDRH/CBER successfully pioneered Bayesian guidance for medical devices to improve decision making and reduce sample sizes. This guidance was motivated in part by the iterative nature of device development, a characteristic common to CMC development. Similar regulatory guidance in the CMC space should facilitate proper adoption of Bayesian methods and the realization of their benefits to regulators, producers, and patients. Regulatory guidance impacts innovation. Regulatory silence, by omission, can also inhibit innovation. Regulatory leadership can encourage innovation by sponsors who might otherwise perceive regulatory resistance.
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