Skip to main navigation Skip to main content
Home
Menu
  • Join Our Mailing List
  • Contact Us
  • About
    • About BBCIC
      • BBCIC FAQs
    • Governance
      • Board of Managing Directors
      • Communications Committee
      • Planning Board
      • Science Committee
    • Partners
    • Contact
  • Research
    • Approach
    • Range of Research
    • Research Plan
    • Research Teams
    • Our Research
    • Publications & Presentations
  • News & Events
    • BBCIC Calendar
    • BBCIC News
    • Quarterly Newsletters
  • Resources
    • BBCIC Resources
    • FDA Guidance
    • Biosimilars Facts
  • Search
 
Enter your keyword(s)

Breadcrumb

  1. BBCIC
  2. Research
  3. Research Plan

Main navigation

  • About
    • About BBCIC
    • Governance
    • Partners
    • Contact
  • Research
    • Approach
    • Range of Research
    • Research Plan
    • Research Teams
    • Our Research
    • Publications & Presentations
  • News & Events
  • Resources
  • Search

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. 

Why BBCIC?
Learn more about BBCIC and what we do.
Download Our Fact Sheet
Join BBCIC
Help us monitor use, impact, safety, and clinical effectiveness of biologics including biosimilars.
Participate in BBCIC

Contact Us

Send a Message

Address

675 N Washington Street
Suite 220
Alexandria, VA 22314

Phone

703.684.2600

Menu

  • About
  • Research
  • News & Events
  • Resources
  • Search
BBCIC Logo
  • Antitrust
  • Privacy Policy
  • Disclaimer

© 2021 Biologics and Biosimilars Collective Intelligence Consortium (BBCIC)

  • About
    • About BBCIC
      • BBCIC FAQs
    • Governance
      • Board of Managing Directors
      • Communications Committee
      • Planning Board
      • Science Committee
    • Partners
    • Contact
  • Research
    • Approach
    • Range of Research
    • Research Plan
    • Research Teams
    • Our Research
    • Publications & Presentations
  • News & Events
    • BBCIC Calendar
    • BBCIC News
    • Quarterly Newsletters
  • Resources
    • BBCIC Resources
    • FDA Guidance
    • Biosimilars Facts
  • Search