(119) Applying Parkinson's Disease (PD) Clinical Trial Eligibility Criteria to US Claims Data by Demographic Distribution

Publication Number: 450

Background: Worldwide, around 10 million people live with Parkinson’s disease (PD), including one million in the US alone. In clinical trials for PD, the majority of participants are white, non-Hispanic, and male, with under-representation of other ethnoracial and sex groups. The extent to which clinical trial inclusion and exclusion criteria affect the demographic characteristics of trial participants remains unclear.

Objectives: To estimate the percentage of PD patients in US claims data who would meet common eligibility criteria for PD clinical trials, by ethnoracial group and sex.

Methods: Out of 78,779,380 patients in the Optum deidentified Clinformatics® Data Mart Database (2004 – 2020), there were 212,491 patients with at least 2 diagnosis codes for PD and without any diagnosis codes for secondary parkinsonism or atypical Parkinson syndromes. Included patients were further reduced to those with 1 year of continuous enrollment during the study period (10/1/2019 to 9/30/2020) (N=61,312) and who were 50-85 years old, resulting in a base population of 48,393. Common inclusion/exclusion criteria were applied to this population and the percentages of eligible participants were calculated across ethnoracial and sex groups.

Results: Among 48,393 PD participants, 28,814 participants (60%) received dopaminergic therapy and did not have claims evidence for: stroke, unstable angina, myocardial infarction, chronic heart failure, chronic hepatic failure, chronic renal failure, or malignancies during the study period. The eligibility percentages were similar after applying the same inclusion/exclusion criteria among the different ethno-racial groups (white: 57%, African Americans: 57%, Asians: 64%, Hispanics: 62%, unknown/missing race/ethnicity: 64%; 58% for females and 61% for males).

Conclusions: The percentage of PD patients in the US claims data who meet common eligibility criteria for clinical trials were similar across different demographic groups, indicating that eligibility criteria are not the main reason for differential inclusion of white, non-Hispanic males in PD clinical trials. Other efforts for recruitment of PD patients are needed to ensure more equitable access to clinical trials across ethnoracial and sex groups. More research is needed using more representative data.