Dr. Stewart on the Impact of Delaying Approval on Overall Survival

September 24, 2015
David J. Stewart, MD

David J. Stewart, MD, head, Division of Medical Oncology, University of Ottawa/The Ottawa Hospital, discusses a study that investigated the impact of delaying approval on overall survival.

David J. Stewart, MD, head, Division of Medical Oncology, University of Ottawa/The Ottawa Hospital, discusses a study that investigated the impact of delaying approval on overall survival, presented at the 2015 World Conference on Lung Cancer.

He and his colleagues looked at randomized trials in different kinds of cancer, published between 2000 and 2015. They took the average improvement in life expectancy in those clinical trials and multiplied it by the number of people dying from that malignancy in North America and worldwide. Their objective was to calculate the number of life years that would be lost per year of delay in getting the drug approved.

In order to illustrate this, Stewart and his team looked at 21 drugs and 11 malignancies. After adding up the results, they discovered that over 2.5 million life years were lost per year of delay in getting the drug approved. This is one for every 12 seconds of delay worldwide and more than 20,000 life years lost in North America alone.