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.