Clinical Research is another emerging field of Life science. The word Clinical trial means “evaluation of new drug”. There are different stages in Drug discovery which are listed as below:
- Drug Target Identification and Validation (Target is a biological molecule which plays an important role in the genesis or development of an illness)
- Developing Leads from Hits, Lead Optimization and Development ('Hit' is a chemical compound that shows activity in primary screen and 'Lead' is a compound with confirmed activity that warrants development)
- Drug Development Process: This process includes- Chemistry and synthesis of drug molecules, In vitro and animal model efficacy, Defining the appropriate dose, Defining the right animal models, In vivo dosage, Pre- clinical drug development stage, Nonclinical drug development stage, Clinical drug development stage, Manufacturing & Filing an Investigational new drug Application
In the above mentioned drug development process, the Clinical drug development stage i.e., the clinical trials is an expensive processes which involve 4 phases
· Phase 1 Safety and Tolerance Study - (20 to 30 healthy volunteers are involved in the study to check for safety & dosage)
· Phase 2 Efficacy Studies - (100 to 300 patient volunteers are involved to check for efficacy & side effects)
· Phase 3 Definitive Safety and Efficacy Studies - (1000 to 5000 patient volunteers are involved for monitoring reactions to long term drug use)
· Phase 4 studies – (are done once the drug has received market approval)
It takes about 15 years and $800 million dollars for researchers to find out a single drug but the cost of conducting the clinical research in India would be quite lesser because India provides number of well trained life science graduates & other required facilities at a lower cost.
