Abstract

EPIDEMIOLOGY STUDY OVERVIEW AND MITIGATION OF CDM CHALLENGES IN EPIDEMIOLOGICAL STUDIES

Shivaji Bote (SME-CDM)*, Dr. Jonathan Dsouza (SME – Patient Centricity) and Sharad Sharma (SME-CDM)

Abstract

Epidemiology involves the scientific study of disease/infection patterns among populations in time and space. The study of cholera in London and its relationship to water supply (John Snow 1855) is widely considered to be the first epidemiological study (Baker et al. 1999). Epidemiology studies provide concrete evidence linking exposure to the incidence of the disease/infection in a population. It can provide accurate estimates of the magnitude of risk related to a specific level of dose or exposure. Epidemiology studies can quantify probabilities that observed relationships took place by chance factors and also possess the potential to control for other risk factors or/and cofounders of the outcome illness being observed. Epidemiology studies used for the setting up of guidelines or evaluation must be of high quality. This will ensure confidence in the validity of the results. In this paper, we provide an overview of the impact of epidemiology trials, different types of epidemiology trial designs, its objectives, challenges of clinical data management in epidemiological studies and suggest effective solutions to ease data management activities.

Keywords: Epidemiology trials, Observational study, Interventional study, Clinical data management, Data collection.