If we talk about the definition of clinical research in simple words, then any research conducted on humans either sick or healthy is clinical research. In order to provide better patient care, this field focuses on developing new diagnostic methods, treatments, or medical devices, as well as improving knowledge about diseases.
What is Clinical Research?
Have you ever taken paracetamol medicine when you suffer from a high fever? Have you ever wondered how paracetamol was discovered and how was it tested on human beings or what dose is safe and effective for therapeutic purposes or at what dose the medicine could have toxic effects? The process of study of all these parameters on a limited number of people before being sold in the market is called clinical research.
But, before testing the drug on human beings, it is very important to follow ethical guidelines to protect the rights of human beings. A lot of clinical trials were performed in history which resulted in the exploitation of human beings which lead to permanent organ damage and those experiments were conducted without their permission. It is very important to take permission from the person on which we are going to test the drug before performing a clinical trial on them.
Clinical research was not so popular field in India but has gained a lot of popularity in the last 4-5 years. Clinical research is very important to study, the safety, benefits, and efficacy of a drug. It is now a revolutionary concept in the healthcare industry.
There are two major types of clinical studies;
- Observational studies (cohort study, epidemiology)
- Interventional studies or clinical trials
Observational studies: By studying the disease, we can better understand its evolution. These analyses are performed within the frame of the patients’ follow-up in the reference centers. Natural history studies are also included.
Interventional studies: Scientific studies provide information about the efficacy and safety of new medications, diagnostic devices, or treatments for illnesses. The process of turning a newly discovered molecule into a pharmaceutical or medical device requires the FDA’s approval.
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