Understanding the Natural History of Disease

UBC helps design and implement natural history of disease studies

Understanding the Natural History of Disease

In-depth study and understanding of the disease or condition for which a drug or biologic is being developed is essential to the scientific foundation of any clinical development program.  That’s why incorporating a natural history of disease study to evaluate patients who have been diagnosed with a specific condition or disease is well worth manufacturers’ time and effort.

A natural history study is a way to:

  • Track the course of a disease over time
  • Identify demographic, genetic, environmental, and other variables that correlate with disease and outcomes in the absence of treatment
  • Document changes in severity over time, occurrence of concomitant conditions, usual treatment patterns, and survival

In addition, understanding the natural history of disease can help anticipate adverse effects as well as help identify milestones when therapy can have the most impact.

Annette Stemhagen provides a helpful overview of this topic in her article, Understanding the Natural History of Disease – a Fundamental Strategy During Drug Development and Beyond, available now online at PharmaPhorum.