Clinical Trial Process | A Thread🧵
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We have discussed the drug discovery process in a previous 🧵. In this 🧵 we will attempt to shed some light on the clinical trials process to enhance our understanding of the drug discovery process
Topics Covered :
1. What are clinical trials
2. Why are they conducted
3. Phase 0 Trials
4. Phase 1 Trials
5. Types of studies in Phase 1
6. Phase 2 Trials
7. Phase 3 Trials
8. Filing of NDA
9. Phase 4 Trials
10. Success rates
1. What are clinical trials ?
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Before doing a clinical trial, investigators conduct preclinical
research using human cell cultures or animal models. For example, they might test whether a new medication is toxic to a small sample of human cells in a laboratory.
2. Why are they conducted ?
Clinical trials are conducted to evaluate if a drug is safe for consumption by
human beings and if it is actually effective in curing or preventing a medical condition or disease. Keep in mind, this will be the first time that the drug will be tested on human beings.
3. Phase 0 trials
Phase 0 trials are also known as human micro-dosing study.