An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees

Conclusion:
The DMC guidance has had a net positive economic impact on the clinical trial enterprise. However, noneconomic factors need to be evaluated. ClinicalTrials.gov could be further leveraged to explore further noneconomic benefits and costs of DMCs.

Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Seltzer, J. Tags: Regulatory Science Source Type: research