Clinical trials can be categorized into different types based on what they are done for.
1. Treatment trials - These seek to find new treatment approaches or compare to identify the most effective treatment available.
2. Prevention trials - They are done to identify approaches to prevent a specific type of disease from developing in people not exposed to it previously.
3. Early detection/screening trials - They are done to find new ways to identify a specific disease/problem in people even before they develop symptoms.
4. Diagnostic trials - These are done to figure out how new tests or procedures can be used to identify a specific disease in suspected population.
5. Quality of life/ supportive care trials - These trials try to identify ways of improving the comfort and quality of life for people with a disease/problem.
The results of a clinical trial is of much significance. Irrespective of the number of subjects or data involved in a clinical trial, the outcome is usually one of the following four types (in case of treatment trial):
Positive trial ‐ Superior (new treatment is better than standard treatment)
Non‐inferior trial ‐ Equivalence (new treatment is equivalent to standard treatment)
Inconclusive trial ‐ Neither superior nor inferior (new treatment is not clearly better nor clearly worse than the standard treatment)
Negative trial ‐ Inferior (new treatment is worse than the standard treatment)
A clinical trial usually starts with a clear investigational plan and an IRB approval for the study. Some components to be considered in the investigational plan are:
– Clinical study protocol - Study, hypothesis and design; Primary and secondary endpoints; Inclusion/exclusion criteria; Sample size and statistical analysis. It is essential to have a clearly defined and firm study protocol that cannot be changed during the course of the study.
– Risk analysis
– Informed consent form
– Case report forms
– Investigator agreement
– Clinical sites (number of sites / investigators / IRBs)
– Bibliography
– Instructions for Use
– Clinical study duration
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