PP02-26: Diversity in Phase I/II/III Lung Cancer Clinical Trials: A Systematic Literature Review of Patient Racial Demographics
Rutgers University United States
Lung cancer is the second most prevalent cancer among both genders with 201,229 new cases for 2016. Of those cases, approximately 40,650 (18.6%) represent individuals from minority backgrounds. Our aim is to analyze the current racial demographics in the lung cancer clinical trial landscape.
PubMed literature review was conducted from 2015 to 2018. 12 published phase I/II/III clinical studies were reviewed to examine the racial demographics of 7701 patients who continued to receive popular checkpoint inhibitor immunotherapy treatment. Keywords include oncology, diversity, and inclusion.
A total of 12 clinical studies were evaluated to investigate racial demographics as it relates to adequate minority representation in lung cancer trials. The combined average demographic breakdown of these 12 clinical trials according to bio-research-defined race was the following: 74.6% of patients were Caucasian, 16.0% of patients were Asian, 1.8% of patients were Black/African-American, 2.2% patients were other, and 4.6% patients were unknown. None of the 12 studies disclosed the number of Hispanic patients enrolled, and only two studies disclosed the number of Native American patients included. Clinical trial “E”, had a racial demographic enrollee group similar to that of what may be seen in the real-world. In this trial, there were 66.7% Caucasians, 19.0% Asians, 9.5% Black/African-American and 4.6% Other.
In most of the clinical trials reviewed, Caucasian had the highest number of enrollees compared to any other racial group. This may be due to issues related to recruitment, site location and patient’s fear, to name a few. The latter numbers were not spread evenly across each clinical trial and were only indicative of one trials that came close to representing the national percentages of lung cancer cases by race. The majority of trials fell short with the lowest reported race-demographics being, 66.7% Caucasian, 2.2% Asian, 0.7% Black/African-American, 0.2% Native American and 1.1% Other.
The 12 clinical trials reviewed indicate a lack of racial and ethnic diversity for patients enrolled in lung cancer clinical trials. 11 out of 12 (92%) trials falls below the 2016 patient demographics. Potential strategies surround eliminating the existing barriers of protocol design, investigator/physician networks, and patient awareness. Analysis of online FDA available documents and other organization guidelines also note these as potential barriers. The inclusion of diverse patient populations can be helpful to better reflect the efficacy and safety of a therapeutic agent in specific racial groups, in order to maximize pharmacotherapy outcomes.