Epidemiology

The word has three components, from the Greek epi, upon; demos, the people; and logos, the study. These elements describe the fundamentals of what epidemiology is all about, the application of scientific principles to the understanding of health issues which are 'upon the people'. All pharmaceutical physicians need an understanding ofthe fundamentals of this field, in order to understand and harness the value that epidemiology, and epidemiologists, can bring to drug development and product surveillance programs. Epidemiology is taught in all schools of public health and, in varying depth and quality, in schools of medicine. Epidemiological techniques are used by many people who would not describe themselves as epidemiologists. Board certification in preventive medicine requires a Master's degree with a large epidemiology component, and further tough examinations.

Such epidemiology training emphasizes the science of the observational research methodology as the core approach of the field. However, emphasis is also given on building expertise in clin ical trials design and biostatistics. These disciplines require expertise and experience in the management of huge quantities of data and the attendant expertise in scientific computing/informatics. These are skills that find natural places in Phase III and Phase IV clinical study design and conduct within industry, and evaluation within the regulatory environment. However, it is in the understanding of the applications (and often more importantly the limitations) of the non-experimental/ observational method that the epidemiologist brings special value-added to the pharmaceutical sector.

It is important to remember that epidemiology represents another set of tactics to address the same underlying motive as others working in and with the development enterprise. Just as much as a molecular biologist or clinical pharmacologist, the epidemiologist is trying to find out which set of conditions causes a particular disease or benefit or adverse event. The additional perspective of the impact upon actual populations (the actual effectiveness) complements the emphasis upon the experimental subject (the efficacy) of much of clinical research. The epidemiologist is faced with the substantial challenge of observational approaches. Without the benefits (comforts) of randomization and blinding afforded by the experimental method, only rarely can the epidemiologist imitate the pharmacologist, who can premeditate an intervention in a confined population, and then prospectively observe its effect. However, even when constrained by the observational approach, the epidemiologist is like other scientists in that findings are in the context of comparison among various structured observational groups, differing in their known exposures or outcomes.

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