A research study or clinical trial is medical research that involves people just like you. People volunteer to participate in studies that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. Many research studies test a new treatment or medical device (i.e. pacemaker) to learn if the new treatment is better than the current treatment being used. Others test a drug against a placebo (sugar pill) to see if the drug helps. Most all clinical studies provide study related care and medication for free, plus compensation for time and travel while participating in the study.
A clinical trial is conducted according to strict guidelines that have been enacted by Congress and the FDA. The study is carried out by following a study protocol, which is developed and designed to safeguard the participants' health and answer specific questions about human health.
There are four types or phases of clinical trials:
Phase I: Is used to test an investigational product or medication in a small group of people (20-80) for the first time. It's purpose is to evaluate it's safety and identify any side effects.
Phase II: The investigational product or medication is tested in a larger group of people (100-300) to determine the proper dose, evaluate its effectiveness and further evaluate it's safety.
Phase III: The investigational product or medication is tested in large groups of people (1,000-3,000) to confirm its effectiveness and compare it with standard or equivalent treatments. Once Phase III is completed, a company can ask the FDA for approval to market the new medication.
Phase IV: Once approved by the FDA, the investigational product continues to be accessed for treatment risk, cost effectiveness, benefits, and optimal use. Researchers are constantly tracking the safety of new medications and looking for any possible side effects.
**For most medications it currently takes approximately 10 years to get a new medication from the laboratory to the pharmacy shelf.