P232: Comparison of Clinical Trial Recruitment to Incidence and Prevalence of Disease in Certain Demographic Populations
Poster Presenter
Evon Okidi
Senior Data Scientist
Medidata Solutions, A Dassault Systemes Company United States
Objectives
We evaluated if clinical trials reflect epidemiological data by comparing the incidence for migraine, lung and breast cancers and prevalence for Alzheimer’s disease against the clinical trial demographic composition of New Jersey, New York, Connecticut, Maryland, and Massachusetts.
Method
We used a relative ratio (RR), proportion of trial patients divided by proportion of population with disease, to determine if trial recruitment was similar to demographic distribution. An RR greater than 1 indicates that trial recruitment was higher than the underlying disease distribution.
Results
For lung cancer, the RRs are lower for Black and Hispanic populations except in New York with the Black population RR 0.948 (95% CI; 0.879-1.022) and Maryland with a noticeably higher representation of the Hispanic population RR 2.699 (95% CI; 2.044-3.564). While New Jersey has comparable performance with most states in the representation of White and Hispanic populations with a relative ratio slightly below 1, the RR of 0.239 (95% CI; 0.217-0.263) for the Black population is the lowest amongst all states, indicating strong lack of representation. Within the analyzed races, the Asian population has the highest relative ratio for all states except Maryland.
Breast cancer analysis shows all race groups except the Black population in Connecticut with a RR of 1.217 (95% CI; 1.083-1.369), have a relative ratio below 1.
Comparison for Alzheimer’s showed that White patients are overrepresented in all states with RR > 1.4, but low representation of Black and Hispanic populations with RR <0.25 for all states.
Migraine trials had the widest variations for Black patients with CT having lowest RR of 0.367 (95% CI; 0.355-0.379) and New Jersey having the highest RR of 2.22 (95% CI; 2.15-2.29).
White populations across all states had RR around 1 and RRs for Asian populations were < 0.5 for all states.
Conclusion
Underrepresentation of demographic subgroups in clinical trials limits the generalizability of trial results, fails to differentiate the safety and efficacy of newly approved drugs between different populations, and hinders equitable access to investigational drugs. Our analysis set out to compare the clinical trial demographic representation across 5 comparable states. The disease indications selected were based on availability of data across all the states. We found underrepresentation of Black non-Hispanic despite having higher incidence of lung cancer compared to White non-Hispanic patients. Similarly, Black non-Hispanic Alzheimer’s disease participants were significantly under-represented across most states despite having 1.5-2 times higher likelihood of developing the disease compared to their White counterparts. There was a higher representation of Asian patients in lung cancer trials and higher representation of Black patients in migraine trials though the cohorts were smaller. Future research should evaluate barriers to proportional demographic representation in clinical trials and better understand differences in behavior across sites within the same geographic area and disease area specialists. These analyses would enable clinical trial participation that more accurately represents disease burden, and inform more effective recruitment efforts.
