Compared with the demographics of lung cancer in the United States, the elderly, minorities, and women remain vastly under-represented in lung cancer clinical trials. These results were presented at the 14thWorld Conference on Lung Cancer.
Clinical trials are the process through which medications ultimately become approved by the Food and Drug Administration (FDA) in the United States. Clinical trials provide necessary information about drug safety, efficacy, and optimal dose and schedule of treatment.
Research has suggested that for some medications, treatment effects vary by age, ethnicity, or gender. If certain subgroups of the population are under-represented in clinical trials, however, it may be difficult to determine whether this is the case.
Researchers from the U.S. FDA recently compiled data to review the demographics of lung cancer in the U.S. and the corresponding representation of these demographics in clinical trials within the past decade for non-small cell lung cancer.
- 75% of patients diagnosed with lung cancer in the U.S. are 65 years or older, whereas only 36% of patients in lung cancer trials were of this age group.
- 58% of lung cancer patients in the U.S. are men and 42% are women; however, only 32% of lung cancer trial patients were women.
- African-Americans develop lung cancer at a higher rate than Caucasians, but this group represented only 2% or less of lung cancer trial participants.
Dr. Shakun Malik, the principle investigator of the study and a medical officer at the FDA stated that “Our results suggest that the trial population used for approval of drugs do not represent well the U.S. population who may receive the marketed agent.”
Reference: Malik S, et al. Poor Representation of Women, Older Age groups and Minorities in US Approval Trials for Non-Small Cell Lung Cancer: FDA Review. Presented at the 14th World Conference on Lung Cancer. Amsterdam, Netherlands. July 3-7, 2011. Abstract O44.06.