ISR asked 30 formulary decision-makers from US-based Managed Care Organizations to indicate their level of concern with potential issues arising from randomized controlled trials for efficacy.

• Inappropriate comparator or dosing of comparator
• Small sample size
• Selective focus on a limited number of intended or unintended effects
• Homogeneous populations, trials may exclude patients from important subpopulations or those with relevant comorbidities
• Limited duration
• Focus on immediate or surrogate outcomes