Research & Education

Impact of Time to Drug Approval on Potential Years of Life Lost: The Compelling Need for Improved Trial and Regulatory Efficiency

September 7, 2015

WCLC 2015

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Becky Bunn
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Impact of Time to Drug Approval on Potential Years of Life Lost: The Compelling Need for Improved Trial and Regulatory Efficiency

DENVER, Colo. — Every hour lost to the cancer drug regulatory process costs 29 life-years lost in the U.S. and 260 life-years worldwide, according to research presented today at 16th World Conference on Lung Cancer (WCLC) hosted by the International Association of the Study of Lung Cancer (IASLC).

Dr. David Stewart, Head, Division of Medical Oncology, University of Ottawa/The Ottawa Hospital, presented data on how the regulatory process of new therapies slows progress by increasing drug developments costs and by producing speed bumps that delay approval of useful drugs. This process also increases resources required to document that other agents are ineffective.

Stewart and his team assessed cancer therapies undergoing phase III trials between 2001 and 2015. To be included, trials had to document statistically significant improvement in overall survival. Adjuvant trials and trials in uncommon malignancies were excluded. To determine the number of life-years potentially lost per year required for drug approval, Stewart multiplied the improvement in median survival in years by the estimated number of patients (North American and worldwide) dying annually from the relevant malignancy.

When the combined impact of all tumor sites and drugs are considered together, there were 29 life-years lost in North America per hour of delay in therapy approval (1 for every 2 minutes of delay) and 260 life-years lost worldwide per hour of delay (1 for every 14 seconds of delay).

Stewart hopes his research will call attention to the adverse impact regulatory delays create. 

“Clearly, the survival gains associated with the foregoing drugs are only modest,” Stewart said. ”However, there would be a large negative impact associated with approval delays even if factors such as co-morbidities, performance status, ability to pay, etc., limit the number of patients treated to a fraction of the total dying from a specific malignancy.”

Stewart stressed that there are numerous opportunities to improve efficiency of cancer drug approval without sacrificing safety or data integrity. “These numbers do not take into account impact of drugs non-evaluable due to cross-over or missing survival data, drugs that were prematurely abandoned, drugs still undergoing investigation, or approaches for non-malignant lethal diseases,” Stewart said.


About the WCLC:

The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting more than 7,000 researchers, physicians and specialists from more than 100 countries. The conference goal is to increase awareness and collaboration so that the latest developments in lung cancer can be understood and implemented throughout the world. Falling under the theme of “Fighting Lung Cancer,” the conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For the first time, IASLC has invited survivors to attend the conference free of charge. For more information on the 2015 WCLC, visit:

About the IASLC:

The International Association for the Study of Lung Cancer (IASLC) is the only global organization specifically dedicated to the study of lung cancer. Founded in 1974, the association's membership includes nearly 4,000 lung cancer specialists in 80 countries. For more information, visit: