PII-033 - EXPANDING THE USE OF REAL-WORLD DATA TO ANSWER CLINICAL PHARMACOLOGY QUESTIONS: DEVELOPMENT OF A USER-FRIENDLY DASHBOARD TO ASSESS PREVALENCE OF ORGAN IMPAIRMENT IN PATIENTS IN THE REAL-WORLD SETTING.

B. Vora¹, E. Velasquez¹, R. Zhang¹, K. Igras², S. James¹; ¹Genentech, ²7N Sp. z o. o..

Background: Renal and hepatic impairment are common comorbidities for patients diagnosed with cancer. Since organ impairment can directly affect the elimination of drugs, it is important to understand the extent of changes in clearance when renal and/or hepatic are the primary route(s) of elimination. However, these patients are often excluded from clinical trials and dedicated studies to evaluate the impact of organ impairment on drug exposure can be challenging to conduct due to the paucity of patients. Increasing accessibility to Real-World Data (RWD) for the evaluation of prevalence and incidence of organ impairment can greatly help in early decision making and planning of clinical pharmacology studies for certain diseases [1-3].

Methods: This study used the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database. Using this data, we developed an easy-to-use dashboard to assess prevalence of organ impairment. Users are able to create virtual cohorts that most accurately represent their clinical trial population of interest, following which the dashboard categorizes patients based on a predefined renal (Cockcroft & Gault) or hepatic (NCI ODWG) impairment criteria.

Results: This dashboard empowers study teams to easily get insights on the real-world prevalence and incidence of mild, moderate, and severe renal/hepatic impairment by increasing accessibility to RWD. Outputs include attribution tables and distribution figures which can be downloaded as PDF or HTML files. Code can also be generated and downloaded to allow replication of the analysis. Additionally, the dashboard has undergone some preliminary validation by replicating analyses performed in previously published work [1,2]. In addition, knowing the incidence of organ impairment in the real-world setting may also present opportunities to include a larger patient population than initially planned in the future clinical trial design.

Conclusion: This organ impairment dashboard puts real-world data and analyses at the fingertips of scientists without requiring any coding skills, allowing for widespread use and adoption of RWD, as well as optimizing clinical trials design and drug development decisions.