BBCIC 2019-2020 Research Plan

BBCIC’s research plans and protocols are posted on ClinicalTrials.gov after they are approved by our Science Committee and Planning Board.

BBCIC’s 2019-2020 research plan covers:

Comparative effectiveness research (CER) that aims to generate real-world information from observational data on the comparative safety and effectiveness between biosimilars and their reference biologics. BBCIC’s research protocols will characterize patient populations, exposures, outcomes, and treatment patterns, as well as identify differences based on treatment regimen. Biosimilar utilization is increasing and BBCIC will begin our research for each biosimilar product as sufficient exposure is captured in the BBCIC distributed research network (DRN).

Descriptive analysis studies are a precursor to actual observational research studies and establish indicators that can be measured by characterizing patient populations, identifying exposures and outcomes, and evaluating patterns of use and clinical risk factors that may influence patient response.

Data and standards workgroups address known or newly identified methodologic challenges and gaps in existing data sources and develop solutions to support future CER work. BBCIC convened four workgroups in 2017 and 2018 and expects publications in 2019 highlighting their efforts. Monitoring queries are conducted routinely across the BBCIC DRN to identify biosimilar and reference biologic utilization patterns as well as define the baseline and demographic characteristics of the populations of interest. BBCIC is taking advantage of the consortium’s uniquely large data network by conducting these routine data queries.