2.1 Data Collection
To obtain participation data for lung cancer phase III clinical trials, the publically available database, PubMed, was queried using the search terms ”((lung[Title] OR pulmonary[Title]) AND (phase 3[Title] OR phase III[Title])) NOT (review) AND (clinicaltrial[Filter] OR randomizedcontrolledtrial[Filter]) AND (fft[Filter])” on April 22nd, 2020. This search yielded 724 publications, from which 426 publications were analyzed as they met the following inclusion criteria:
The study was a Phase III Lung Cancer Clinical Trial
The study did not present data from a previous clinical trial already recorded in our database (to avoid duplicate recording of data)
The 426 publications were subsequently used to collect year of publication and demographic data relating to participants’ race and sex from the study’s demographic table to construct the database for the analysis (Figure 1). Most of the studies the search yielded were multinational studies, which was determined by reviewing the author affiliations of these publications. The review of publically available data could not classify them into discrete categories of U.S. vs other regions. This study was considered exempt for IRB review per institutional policies.
Figure 1. CONSORT diagram illustrating the study selection process.
For race, the number of White, Asian, African American, and Hispanic participants were recorded. The category “Other” was also used to include any participants that were listed as Other in the original study or did not belong to the White, Asian, African American, or Hispanic groups. The final category of “Unknown” was used to include any participants that were listed as Unknown in the publication. The number of participants in each category were then converted to the percent of the total participant pool each category represented and were then used to compare participation rates across studies. The studies that did not report demographic data on racial background were annotated as such. For sex, the total number of males and females was recorded. These values were subsequently used to calculate the percent of the participants’ pool that was male or female, and the studies that did not report demographic data regarding sex were annotated as such. The data collected was then used to determine the percent of studies that reported participant race or sex, differences in the rate of participation among racial groups and between sex, and how participation rates of have changed over time.