Anne-Marie Nagy, Ph.D., Executive Director, Strategic Development, Neuroscience, Premier Research
Todd Leathers, MBA, Executive Director, Strategic Development, Neuroscience, Premier Research
Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Diagnosis alone is tricky, given the often-delayed onset of symptoms, and optimizing study design, recruitment, event adjudication, and biomarker use complicates things further.
You can’t generate high-quality data without reliable diagnostics and accurate, meaningful phenotypic descriptions and evaluation outcomes. You also need to enroll the right patients and engage the best investigators and staff to minimize rater variability and comply with the often complex protocol requirements.
Systematic selection bias is another recurring concern in these trials, whose participants tend to skew disproportionately young and male, with too little representation by non-Caucasians.