"Somewhere, something incredible is waiting to be known. The only way to find is research and clinical trials"
At Nims Super-specialty Hospital & NIMS Medical College (National Institute of Medical Sciences) research Researchers conduct clinical trials to try to learn if an experimental new drug works and is safe in humans in order for it to be approved. Clinical trials may also study a medical device or a medical procedure. A number of clinical trials are being conducted on a regular basis in Nims Super-specialty Hospital & NIMS Medical College (National Institute of Medical Sciences) Research.
It takes a lot of research to develop a new drug treatment. Clinical trials are done in several steps, also called “phases”. Each phase has a specific purpose. The phases are designed to answer certain questions about the experimental drug being tested while aiming to keep the participants in each trial as safe as possible.
Researchers study experimental drugs in a lab before studying in humans. This type of research study is called a "pre-clinical trial". The goal is to collect information about the experimental drugs. Then researchers ask the government and other independent groups for permission to begin a clinical trial in humans. Pre-clinical trials are required before the experimental drug can be studied in humans.
Phase 1 clinical trials are the first step after the pre-clinical trials. The Phase 1 clinical trials are usually the first time a new experimental drug is studied in humans. A Phase 1 clinical trial tests the drug in a small group of people (usually 15-100 participants). Researchers design Phase 1 clinical trials to learn:
*What the experimental drug's serious adverse effects are
*To find a dose that can be given
*How the experimental drug is absorbed and processed in the body
Phase 2 clinical trials are done to learn how well the experimental drug is working in people who have a disease or condition. There are usually 100-500 participants. Researchers design Phase 2 clinical trials to:
*Learn if the experimental drug may work in people who have a certain disease or condition
*Continue to learn about which dose of the experimental drug works
If the results of Phase 1 and Phase 2 clinical trials are positive, the experimental drug is studied in a larger number of participants with the disease or condition. There are usually 1000-5000 participants. Researchers design Phase 3 clinical trials to:
*Confirm the medical adverse effects and the results seen in earlier phases
*To learn how well the experimental drug works compared to another drug or compared to a placebo
This is also referred to as post marketing surveillance and as the name suggests, it is conducted after the drug is already marketed and available to the general public. The main objective of the phase 4 trial is to check the drug's performance in real life scenarios, to study the long-term risks and benefits of using the drug and to discover any rare side effects. In a phase 4 trial, any rare or long-term effects of the drug can be observed in a much larger population of patients and over a much longer period of time. If safety surveillance does indeed reveal concerns about the drug, it may be withdrawn from the market and no longer made available on prescription.