What Does Clinical Trials Day Mean to You?

Full interview summary

In a recent video interview with Applied Clinical Trials, Sam Hinsley, statistics manager at Phastar, discussed the critical role statisticians play in clinical trial design and analysis, and why raising standards in early phase research is essential to improving the odds of getting effective treatments to patients. Speaking on the occasion of Clinical Trials Day, Hinsley opened on a personal note, sharing that she has type one diabetes and has seen firsthand the impact that clinical trials can have through new treatments and devices—a reminder, she noted, of why choosing to work in this field matters.

Hinsley argued that statisticians are fundamentally stewards of patient data, and that the responsibility to use that data properly—at every stage of development—requires both innovation and discipline. She emphasized that innovation in statistical methodology should always be purposeful, driven by a need for more accurate or more efficient answers rather than novelty for its own sake. As medicine grows more complex, from personalized therapies to rare disease contexts with limited data, she pointed to Bayesian approaches, adaptive designs, and the emerging role of AI as areas where statisticians must lead.

On collaboration, Hinsley was emphatic that cross-stakeholder input is not optional, particularly as trial designs grow more sophisticated. She drew on the example of immunotherapy, where the assumptions underlying traditional cytotoxic trial designs simply did not apply, to illustrate what can go wrong when methodological evolution outpaces shared understanding across disciplines.

Hinsley also spoke about the Early Phase ESIG, a special interest group she helped launch to bring together statisticians from academia and industry around the shared goal of raising standards in early phase research. With nearly 30 members, the group focuses on knowledge sharing and keeping pace with evolving guidance such as FDA's Project Optimus. She closed by underscoring why early phase decisions are so consequential—with only around 10% of drugs entering humans ultimately reaching approval, getting dose selection and design right at the outset can mean the difference between a drug that reaches patients and one that never makes it through.