Clinical trial phases
clinical research phases
● Phase I of clinical trials usually studies new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
● Phase II of clinical trials studies test treatments that were found safe in phase I of clinical trials. However, phase II is conducted on a larger group of human subjects for monitoring any adverse effects.
● Phase III of clinical trials is conducted in different regions and countries and on larger populations. Phase III is the step conducted right before a new treatment or drug is approved.
● Phase IV of clinical trials is conducted after a country approves, but there is still a need for further testing efficacy in a larger population over a longer timeframe.
There are various guidelines outlined by different international and national organizations for ensuring careful design, review, and completion of the process. Clinical trials require approval before they can even begin. People of all ages, including children, can volunteer to participate in clinical trials. However, various guidelines direct the participation of people in clinical trials. These guidelines can relate to underlying health conditions, side effects from other drugs, and so on.