Author's Note:
The author is a business system analyst primarily analyze clinical trials data. From the knowledge he gained from his professional experience and reading various articles, he is in the process of collating information related to clinical trials and publish them in this blog. This blog will be helpful to understand core functional concepts of clinical trials and perform in depth data analysis. Users can click on Next link available at the bottom of every page to navigate to subsequent pages.
Introduction to Medical Research:
As Clinical Trials are part of Medical Research let us first understand about Medical Research and how it is classified.
Medical research involves research in a wide range of fields, such as biology, chemistry, pharmacology and toxicology with the goal of developing new medicines or medical procedures or improving the application of those already available.
In general, Medical Research can be categorized into Primary and Secondary research. Primary research involves conducting studies and collecting raw data that is then analyzed and evaluated in secondary research.
Classification of Medical Research is shown in below diagram:
As we see in the above diagram, Clinical Research is a component of medical and health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness, and promoting health..
Clinical Research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. Clinical Research is different from lab research. Lab research generally do not involve people although, it helps us learn which new ideas may help people.
Every drug, device, tool, diagnostic test, technique and technology used in medicine today was once tested in volunteers who took part in clinical research studies.
Clinical Research is further classified as
As per Dr. W.E. Deming, father of Quality Management, studies can be classified into two types:
- Enumerative Study
- Analytical Study
An Enumerative Study proceeds by investigation of the material in a Frame. A Frame is a list of physical units of some kind, identifiable by serial number, any or all of which may be selected and investigated. In Enumerative study, action will be taken on the material in the Frame to be studied… The aim of a statistical study in an Enumerative problem is descriptive — how many or how much? The aim is not to find out why there are so many, or why there is so much, but merely to quantify the material in the Frame.
An Analytical Study is one in which action will be taken on the process or cause-system that produced the Frame studied, with the intent being to improve practice in the future. Here interest centers in future product, not in the material studied.
As we see above, Clinical Trials comes under Analytical studies umbrella.
Next: What is a Clinical Trial
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