Pharmaceutical Industry and Clinical Trials

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 trials.

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.