Posted by on May 1, 2013 in Blog | 2 comments

Not with these trials.  Clinical trials are scientific studies conducted to discover improved ways to treat, prevent, diagnose or screen for diseases.

Clinical trials are either observational or interventional.  Observational trials are like longitudinal studies.  Interventional trials are the ones in which individuals are assigned to control or treatment regimes (described in this post).

Not only are there two types of clinical trials, but, to add to the confusion, they come in phases.

Phase I are the first small-scale test of a treatment to determine safety, correct dosage and side effects.

Phase II continues to study safety and side effects of the treatment with larger groups of individuals.

During Phase III, the experimental treatment is compared to standard treatment.  This is a larger study that can provide further information on safety and side effects.

Phase IV trials are conducted after the U.S. Food and Drug Administration (FDA) has approved the treatment for use.  Information is obtained on the long-term usage of the treatment.

The U.S. Food and Drug Administration is involved throughout the process.  Pharmaceutical and device manufacturers provide detailed documentation.  The production of treatments can be tabled during any of these phases if the treatment is ineffective, unsafe or has deleterious side effects.

So, like jury duty, clinical trials can be arduous…but they are a vital element for the progress of medicine and science.  “Raise your hand and repeat after me….”

(future posts will talk about the pros and cons of participating in clinical trials)