BBCIC Range of Research

BBCIC research priorities fall into four primary categories as illustrated below. Research projects may utilize the BBCIC Distributed Research Network (DRN), where we have access to ~95 million patient lives in administrative claims, but we also consider projects that drive BBCIC DRN data capabilities and expand our existing resources.  Here we provide more detail describing projects that may fall within each category. 

Studies will be focused on biologic drugs, including, but not limited to, biosimilars or reference biologics for which a biosimilar is available or anticipated.  

 

 

  • Descriptive and Comparative studies should fall into one of three further subcategories: 

    • Clinical Safety and/or Effectiveness 

    • Treatment Patterns and Outcomes  

      • (e.g., assessing care pathways, population characterization, disease natural history) 

    • Treatment Guidelines  

      • (e.g., comparing outcomes among patients treated according to established guidelines vs those not treated according to guidelines, evaluating outcomes where there are multiple acceptable choices, etc.) 

  • Descriptive Analyses 

Often the first step towards conducting comparative studies, descriptive analyses are intended to answer questions around the available data (e.g., suitability of the data to conduct comparative/inferential analyses), to ensure feasibility for identifying relevant variables, and to describe the populations, exposures/product utilization, and outcomes of interest. 

  • Comparative Analyses 

Comparison of outcomes of interest; could compare outcomes between patients according to treatment cohort (e.g., patients receiving one product compared to those receiving other products across a therapeutic category). Studies could also address comparison of outcomes based on specific treatment or care pathways. 

  • Methods and Infrastructure 

Studies to address current gaps in research methodology relevant to observational research of biologic products, and to identify solutions to enhance the data capabilities of the BBCIC through enrichment of the existing Distributed Research Network (DRN) and identification and incorporation of new or alternative data sources. 

  • Exploratory Research 

Considering topic areas that are, or are expected to be, significant in healthcare (any stakeholder) based on anticipated scientific advances or changes to the management of populations with disease. This can include new treatment models, approaches and pathways that develop based on any aspect of the health care continuum.  

Priority Drug/Disease Areas (in no particular order) 

  • Inflammatory Conditions (e.g., rheumatology, gastroenterology, dermatology) 

  • Insulins 

  • Oncology (non-pediatric) – particularly in cases where there are multiple products or treatment regimens available 

  • Others may also be reviewed based on market demand or FDA approvals