Pharmaceutical Industry and
The developers and innovators
of a drug need to do clinical development. The clinical
development of a drug encloses discovery, development, pre-clinical research, clinical
research, regulatory review, and post-market safety monitoring.
Researchers and Healthcare
professionals conduct clinical research trials and clinical
studies on a group of people who volunteer to take part in clinical trials to test medical
interventions, including drugs, cells and other biological products, surgical procedures,
radiological procedures, devices, behavioral treatments and preventive care. After clinical
trials, the drugs are approved by the national regulatory authorities, like the US Food and
Drug Administration (FDA), the European Medicines Agency (EMA) and the Australian
Therapeutic Goods Administration (TGA), after completing all the required stages of clinical
There are four phases in a clinical trial:
- Phase I studies: Usually test new drugs for the first time in a
small group of people to
evaluate a safe dosage range and identify side effects.
- Phase II studies: Test treatments that are safe in phase I but now
need a larger group
of human subjects to monitor for any adverse effects.
- Phase III studies: This phase is conducted on larger populations
in different regions
and countries and is often the step right before a new treatment is approved.
- Phase IV studies: Take place after country approval, and there is
a need for further
testing in a wide population over a longer timeframe.