Why Four Regulatory Scenarios Could De-Risk Selective Safety Data Collection

Full interview summary

In a recent video interview with Applied Clinical Trials, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discussed the collaborative work underway with FDA and CTTI to explore selective safety data collection as a model for de-risking and modernizing clinical trial design. He opened by highlighting four regulatory scenarios developed across different therapy areas and asset maturity levels, describing them as a blueprint that sponsors can use to identify where this approach might fit within their own portfolios and engage the agency with greater confidence and the right cross-functional representation.

DiCicco pointed to concrete evidence supporting the approach, citing a CTTI white paper that found reductions of 50 to 75% in the number of visits and assessments across three programs using selective safety data collection, with no corresponding loss in data quality. He emphasized that this is not zero safety data collection, but a selective approach applied specifically to mature assets with robust existing safety and efficacy data, where the risk of missing a meaningful signal is low.

He connected the approach directly to the broader push toward decentralized and pragmatic trial designs, arguing that the real value lies not in running a single pragmatic or decentralized trial successfully, but in building the scalability to repeat that success across a sponsor's portfolio. DiCicco also stressed that meaningful progress requires alignment not just between regulators and sponsors, but across a broader ecosystem that includes healthcare practitioners and patient communities, pointing to the ICH E6(R3) update's emphasis on quality by design and stakeholder engagement as a structural opportunity to formalize that collaboration.

He closed with an optimistic outlook on where selective safety data collection could lead, framing it as an entry point into a broader practice of simplification that could ease the operational burden of pragmatic and decentralized trials more broadly, while also helping address a shrinking investigator pool by making trial participation more accessible and sustainable for sites.