Clinical testing

Revision as of 19:52, 16 August 2015 by Frodo (talk | contribs) (asdf)
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to navigation Jump to search

Clinical testing or clinical trials is the long and expensive process of investigating whether a drug candidate is suitable to become a drug.

In the US, this process is supervised and regulated by the Food and Drug Administration (FDA).

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions. Before clinical trials can begin, the compound is registered as an investigational new drug (IND) with the FDA.

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Successful completion of Phase III results in a new drug application (NDA) which can be marketed (and, importantly, sold).

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

In practice, Phase IV trials are rarely followed through because they are often not mandatory. Special rules apply to orphan drug trials.,2015&intervention_names-match=domperidone