ACT Brief: CTTI Risk Myth-Busting, Hidden ePRO Exclusion Criteria, and Patient-Centered Care Models

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part four of his interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discussed how CTTI tabletop exercises are myth-busting perceived risks around pragmatic trials and selective safety data collection. True progress requires genuine partnership across regulators, sponsors, providers, and patients to operationalize these approaches and overcome organizational resistance rooted in misconceptions rather than evidence.
• In a new contributed article, Rakshinda Mujeeb examined how screening for "tech-savvy, engaged" participants in ePRO-heavy trials creates a hidden, unexamined eligibility criterion that systematically excludes populations the drug is meant to treat. When protocols fail to design engagement into study execution through low-tech options, digital literacy support, and caregiver-tracked data, they diverge from real-world populations and produce efficacy data that doesn't reflect post-approval use patterns.
• In a Pharmaceutical Executive piece, Shaun Noorian, founder and CEO of Empower Pharmacy, argued that declining patient engagement across demographics reflects system design failures rather than patient behavior. Healthcare models built around institutional efficiency and standardized protocols fail to serve patients whose biology requires individualization, driving migration to care models that prioritize personalization over standardization.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.