Services

Quantitation of the incidence

MedixGlobal has access to a vast network of real-world data sources. Our goal is to determine and quantify benefits, risks and outcomes of interventions through observational studies such as nested case-control or retrospective cohort studies to address unmet medical needs. We provide epidemiological and outcome data for observational research on the natural history of the disease; compare safety and effectiveness of medical treatments; design methodologically sound studies to meet project objectives and regulatory requirements; conduct/supervise analyses, and evaluate and report study results. We also have the ability to run studies on the use and effects of drugs in large numbers of people. Eventually, the main goal is to get a better quantitation of the incidence of known adverse and beneficial effects.

Potential contributions of Pharmacoepidemiology

A. Information that supplements the information available from premarketing studies, better quantitation of the incidence of known adverse and beneficial effects.

  • Higher precision
  • In patients not studied prior to marketing, e.g., the elderly, children, pregnant women
  • As modified by other drugs and other illnesses
  • Relative to other drugs used for the same indication

B. New types of information not available from premarketing studies

  • Discovery of previously undetected adverse and beneficial effects
    a. Uncommon effects
    b. Delayed effects
  • Patterns of drug utilization
  • The effects of drug overdoses
  • The economic implications of drug use

C. General contributions of Pharmacoepidemiology

  • Reassurances about drug safety
  • Fulfilment of ethical and legal obligations

Type of studies

Observational studies (retrospective cohort or nested case-control):

  • Without treatment allocation by chance, bias due to different baseline risks for disease in users and non-users of drugs cannot be ruled out completely – confounding by indication.
  • The potential for confounding is probably larger in observational studies assessing medications than in studies assessing lifestyle factors.

Example

Generally speaking, we compare groups of individuals who are alike in many ways but differ by a certain characteristic. For example, HCV-infected patients who got a specific treatment (like interferon-based therapy) and ones who did not receive IBT in terms of a particular outcome (such as rheumatoid arthritis (RA)). Data on the relevant events for each individual are collected from existing records and can be analysed to determine the relative risk of the cohort compared to the control group. We collect the form and time of exposure to a factor, and the time of any subsequent occurrence of the outcome.
The objectives of this study were to highlight the association between interferon-based therapy (IBT) and the risk of rheumatoid arthritis (RA) in patients infected with hepatitis C virus (HCV).