Clinical Research: Phase 1 - Phase 4

5 Tips for Designing and Operationalizing Natural History Studies

Natural history studies document the natural course of a disease, starting just prior to its inception and progressing through its pre-symptomatic phase and different clinical stages until the patient is cured, chronically disabled, or deceased. These studies play a crucial role in drug development—especially for rare diseases. In addition to providing insights that advance discovery and shape clinical trial design, these studies can be used to deepen understanding of patient journeys, clarify the standard of care, identify disease-specific centers of excellence, and surface opportunities to improve outcomes. Natural history studies, however, require careful planning and built-in flexibility to accommodate changes that may be needed as new knowledge emerges. This is where Premier Research can help.

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