This article will discuss the process and roadmap needed for optimizing clinical study and trial and review why and how are the Trials being performed.
Clinical study is a research which involves human volunteers, also called as participants, with an intention to add to the medical knowledge.
Mainly there are two types of clinical studies, namely: Clinical Trial (aka Interventional Study) and Observational Study.
Clinical studies are the experimental studies to determine a better treatment of a particular disease. They are designed to answer specific scientific questions like:
- What side effects do the drug have?
- Does it reverses or stops the disease for which it is designed to heal?
- Are the outcomes effective than existing treatments?
- Can it be given along with the drug which is already being given for the same disease?
The answer to every question above must come in the form of scientific data and not in the form of opinions or the impressions of the scientists, doctors or patients involved with the studies.
The results can be enclosed by many factors and can be affected by bias. It is to be made sure this does not happen.
Clinical Trials are clinical studies for exploring a medical strategy, devices or a treatment, which is safe as well as effective for humans.
Also called as interventional study, clinical trial is a clinical study where participants are assigned to receive one or more inventions or sometimes no inventions at all, for the researchers to evaluate intervention's effect on health related outcomes. For certain illness in humans or a particular group of people, these studies help to find out which medical approach will work better to their cure.
What is a Clinical Trial Intended for?
The main purpose of performing a clinical trial is nothing but a research and so strict scientific standards are followed . These standards are required to be maintained for the protection of patients and generate study results which are reliable.
How are the Clinical Trial Approved?
Before starting a Clinical Trial, the protocol or the plant of the trial is approved by an independent and unbiased group of researchers who are not going to e involved in the trials, which is called an independent scientific review.
The trial protocol is reviewed by National Research Ethics Service, which is a Research Ethics Committee. The aim is to be concerned with the rights, safety, dignity and well-being of the patients taking part in trials. This committee is made up of 7 and 18 volunteers.
The researchers are bound with the protocol they proposed at the beginning of the trial. they cannot change the protocol without approval from ethics committee. They have to report to the ethics committee in case of any happening of serious side effects in-between trial. The committee receive reports at the end of clinical trial.
How is the Clinical Trial Performed?
The process of a clinical trial begins in the laboratory. The scientists develop and test the ideas regarding the tests. Clinical trials are performed as a part of one of the final stages of a lengthy and carefully performed research procedure.
If the basic idea of clinical research is worth promising, animal testing is performed as the next step.
- Why are animals used for clinical testing?
Using animals for clinical tests is because there is a need to find out what happens to a living body. Replacing animals with any other alternative method of testing samples is not yet discovered. As the basic cell formations of animals are similar and human's body performs same tasks of movement, breathing, hearing, digestion, sight and reproduction, it is likely to perform tests on them rather experimenting them on humans first. Before testing ideas on humans, animals such as rats are used for sampling.
- What does the animal testing indicate?
It shows that how the biomedical approach will affect a living body and whether it is harmful or not.
However, it may be possible that the approaches working well in labs or on animals are not necessary to show exact results in case of humans. Hence, it is required to perform tests on humans.
As a safety measure, clinical trials are performed on a small group of people on initial stage and it is found out whether it affects or harms humans or not. The later phases of clinical trials involve larger amount of humans on which the study is focused.
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