Clinical & Pharmacoepidemiology

Exponent’s staff of epidemiologists, statisticians, clinicians, and clinical toxicologists provides the expertise needed for the rigorous conduct and evaluation of clinical epidemiology and pharmacoepidemiology studies. Exponent staff have provided clinical epidemiology and pharmacoepidemiology consulting services on numerous projects, including the following:

  • Cardiovascular disease risk among women using dietary supplements
  • Liver failure risk among users of anticonvulsants
  • Clinical and economic impacts on asthma and COPD of a new respiratory bronchodilator
  • Effectiveness of adding omega-3 supplements to diet
  • Assessment of potential patient population size for proposed orphan drug application and filing of a Pediatric Investigation Plan
  • Epidemiologic evaluation of factors influencing patterns of care in chemotherapy treatment for common female cancers
  • Descriptive epidemiologic characterization of various childhood bone disorders for assessment of population in need of treatment for these rare childhood diseases
  • Epidemiologic characterizations of rare blood disorders in the general population
  • Meta-analysis of prognostic factors after liver resection in metastatic colorectal cancer
  • Risk of urothelial carcinoma with implanted medical devices.
  • Our epidemiologists and statisticians have published numerous peer-reviewed scientific papers on topics related to clinical epidemiology and pharmacoepidemiology, including drug therapies, medical devices, health care access and costs, pharmacovigilance and surveillance, meta-analysis, and methodological issues.
What is Clinical Epidemiology?

Clinical epidemiology evaluates the effects of particular treatments, patient factors, and healthcare provider characteristics on disease outcomes, and is essential to evidence-based medicine. This area of epidemiology includes research on disease prevention, screening, diagnosis, management, prognosis, and patient-centered outcomes.

What is Pharmacoepidemiology?

Pharmacoepidemiology involves the evaluation of the uses and effects of drugs and other pharmaceutical agents to alleviate or cure diseases in defined populations. The effects of interest of such agents, including drugs, biological agents, and medical devices, can include both adverse and beneficial effects. Pharmacoepidemiology can be used for comparative drug effectiveness and comparative drug safety research studies, which compare beneficial or adverse outcomes between two or more pharmaceutical agents used to treat the same medical condition.

Other areas of clinical epidemiology and pharmacoepidemiology include the design and analysis of clinical trials, meta-analysis of treatment effects, evaluation of spontaneous reports of adverse events, and pre- and post-marketing safety assessments using clinical trials data.

Clinical epidemiology and pharmacoepidemiology rely on the same study designs, analytical methods, and statistical modeling techniques as other branches of epidemiology. These fields also offer unique challenges in terms of controlling for confounding factors (especially underlying medical conditions), minimizing detection bias, addressing the limitations of health care databases, obtaining accurate assessment of drug exposure and use, and accounting for potential selection bias.

Objectives of Pharmacoepidemiology Safety Studies

The key objectives of pharmacoepidemiology safety studies are to identify the types and frequency of adverse events associated with a given agent and to determine reasons that may explain the adverse events. Relevant questions can include the following:

  • Are the events dose-related?
  • Does the pharmaceutical agent interact with other medications or substances to promote adverse events?
  • Are certain high-risk subpopulations or pertinent lifestyle factors related to the event?
  • Is the pharmaceutical agent being used in accordance with label instructions?

Observational pharmacoepidemiology studies provide "real world" assessments of potential short-term and long-term benefits and adverse drug events in populations with more diverse range of providers, patient health status and demographic characteristics and a longer follow-up period than in clinical trials, which evaluate initial drug efficacy and safety in highly selected patient populations.