Researchers at BCDSP have over 40 years of experience designing and conducting observational research in pharmacoepidemiology and disease epidemiology. We use electronic patient data collected in the United Kingdom and United States and rigorous epidemiological and statistical methods to produce real world evidence to support clinical, regulatory, and pharma decision making. Studies are conducted on a contract basis in collaboration with regulatory authorities or the pharmaceutical industry. 

BCDSP does not conduct or analyze data from clinical trials.

Study design, conduct, and analysis

We design and conduct studies of observational drug safety and disease epidemiology in UK, European, and US data sources. We provide expertise in organizing, analyzing, and interpreting data from large electronic medical databases from a variety of sources (e.g., claims records, electronic medical records, and registry data). Our researchers play a key role in ensuring studies are feasible and methodologically sound. We use established, rigorous epidemiological and statistical methods to address issues of bias and confounding, particularly those inherent in observational drug studies using real world data.

  • Expertise in UK, European, and US data sources
  • Study planning and protocol design, including Post Approval Safety Study (PASS), are performed in collaboration with clients
  • Methodological considerations include:
    • Appropriate definition of exposures and selection of comparison groups 
    • Study specific outcome definitions
    • Variable lengths of patient follow-up, time-varying exposures, and database specific idiosyncrasies and inconsistencies
    • Protopathic (reverse causality) bias, immortal time bias, confounding by indication, and other confounders 
    • Statistical analyses appropriate to each study question and data source
  • Capabilities cover an array of modern methods including logistic regression, Poisson regression, Cox proportional hazards, marginal structural models, Kaplan Meier modeling, and propensity score matching

Data sources

Our epidemiologists conduct studies in UK and US electronic health record and claims databases.

  • United Kingdom CPRD: BCDSP researchers are experts in the use of CPRD GOLD and Aurum and their linked inpatient, death and registry datasets
  • US claims: IBM MarketScan, IQVIA PharMetrics, Optum
  • US EHR: Department of Defense, Kaiser Permanente, Group Health Cooperative of Puget Sound
  • Coordinates studies in collaboration with multiple European data sources

Validation

Validation of data sources, exposures, outcomes and important confounders is vital to producing reliable research.

  • Each study conducted at BCDSP includes validation components with all available internal and external data sources
  • Conducts data source validation studies on new data sources

Publications, presentations, and reports

We are committed to publishing all research relevant to the medical and public health community. All manuscripts are written by BCDSP epidemiologists and our collaborators. We also write abstracts for submission to research conferences and provide content for conference presentations and posters. We write reports for regulators including PASS reports.

  • Committed to publishing all BCDSP research that is valuable to the medical and public health community
  • Detailed reports for internal company use
  • Manuscripts for submission to peer reviewed journals
  • Regulatory reports, including PASS
  • Abstracts for submission to research conferences and content for conference presentations and poster

Training opportunities

There are many opportunities at the BCDSP for masters and doctoral students, postdocs and other professionals to develop expertise in the use of large electronic medical data and appropriate pharmacoepidemiological methods. Examples of prior local and international student research projects can be found in the “Guided Student Studies” section on the Research Page.