Lung cancer is the leading cause of cancer death in the US and the second most common type of cancer among both men and women. Smoking is directly related to 90% of lung cancer in men and 80% in women, causing more than one in five deaths. Since 1964, the Surgeon General’s Warning on tobacco products has produced a 50% drop in smoking, illustrating the power and reach of this messaging. Clinical trial awareness could benefit from this type of support. With only 3% of adults with cancer participating in clinical trials, many more are needed to advance treatment options.
Link 1: New York Times article on the need to increase clinical trial awareness and education to advance oncology research and treatment options.
Link 2: Meta-analysis and review of studies to determine barriers to oncology clinical trial participation.
Link 3: Lung cancer incidence rates and association with smoking.
Initially, the Surgeon General must agree to modify the warning label. The Surgeon General, Vivek Murthy, is co-founder and chairman of TrialNetworks, a system designed to improve the quality and efficiency of clinical trials, so he understands the importance of creating greater clinical trial awareness. Due to recent rulings surrounding the Tobacco Control Act of 2009, the FDA must develop new warning labels, so the time is opportune to add clinical trial messaging. There will likely be push back from the Tobacco Industry; however, media can capitalize on this process, which will result in greater exposure and awareness of clinical trials.
We aim to increase the percentage of adult cancer patients participating in clinical trials from 3% to >6% in the first year following modification of the warning label as described. We anticipate that all major media outlets will report on this change given the political situation surrounding tobacco use. In a recent Gallup poll, 55% of Americans reported receiving information about events from television, allowing for an anticipated reach of 175.4 million. If only 2% of those individuals visit the website, 3.5 million will explore clinical trial opportunities, allowing for cancer patients to be matched to clinical trial opportunities.
http://www.gallup.com/poll/163412/americans-main-source-news.aspx
Our proposed solution will maintain clinical trial awareness through continued and consistent messaging found on all tobacco products sold in the United States. In 2011, over 293 billion cigarettes were purchased, allowing for a substantial reach to potential patients. The website listed on the labels will need to be maintained to provide information on all current clinical trials and patient matching services will need to be staffed appropriately.
http://www.cdc.gov/tobacco/data_statistics/fact_sheets/economics/econ_facts/
The proposed addition to the Surgeon’s General Warning will be included in the new warning labels being developed as a result of the Tobacco Control Act of 2009 and will be approved during this process. No additional legal or regulatory approvals will be necessary. Any clinical trials advertised on
www.cancer.org/clinicaltrials (or an alternative website) must receive central IRB approval prior to display.
Traditional patient recruitment initiatives aim to identify niche populations to enroll into specific studies and focus on identifying protocol-eligible patients within physician offices and surrounding communities. Our approach is the antithesis: to increase accrual of oncology clinical trials, we aim to dramatically increase awareness of opportunities by targeting the behavior associated with the leading cause of cancer death in the United States. As this approach is truly innovative, we ascertain that this project will attract substantive media attention to generate an increase in trial awareness and participation among both smokers and non-smokers and will not be limited to lung cancer.
