Next Phase of Genetic Counseling in Clinical Trials: Derek Ansel, MS, CGC

WATCH TIME: 3 minutes

"It takes a village to run a clinical trial—and I can’t think of a better profession than genetic counselors to fill the gaps across every stage of research."

The field of clinical genetics has rapidly expanded beyond diagnostic testing, now influencing the design, execution, and interpretation of modern clinical trials. As neurology and rare disease research increasingly adopt genetically defined endpoints and biomarker-based study designs, the role of genetic counselors (GCs) has evolved from patient-facing educators to integral contributors across the entire research continuum. Their expertise in genetics, communication, and ethical decision-making offers unique value to trial operations, especially as precision medicine becomes central to drug development.

This transformation comes at a time when the clinical research ecosystem is under immense pressure: trials are becoming more complex, more expensive, and more patient-specific. As such, GCs are being called upon to support data analysis, regulatory submissions, and even early-stage trial strategy, particularly in neurology and rare genetic disorders, where approximately 80% of cases have a genetic etiology. The expanding intersection between clinical genetics and therapeutic development has created new opportunities for GCs to influence how trials are designed, run, and interpreted.

At the 44th National Society of Genetic Counselors (NSGC) Annual Conference, held November 6-10, 2025, in Seattle, Washington, Derek Ansel, MS, CGC, presented on “The Next Phase: The Evolving Role of Genetic Counselors in Clinical Trials and Research.” Ansel, vice president of rare disease strategy at Worldwide Clinical Trials, spoke with NeurologyLive® about the key themes from his session, and how GCs can apply their skills beyond traditional clinical settings. Throughout the conversation, he spoke on interpreting complex biomarker data, improving collaboration, and the ways GCs can bridge the gap between science, ethics, and patient care.

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