What is Clinical Research

Research studies occur all over the world. They occur in various setting such as community and university clinics/hospitals, doctors’ offices, and veterans and military hospitals. 

A new drug or device may take up to 8-10 years to get approved by the Food and Drug Administration (FDA) for use by patients. 

There are usually 4 phases in research. Pre-clinical testing, which takes 3-4 years, is usually done on animals to explore the safety and potential benefit of a new product. After this phase is completed, a company may submit the results to the FDA. The company must provide all information obtained during the pre-clinical testing and must define how they propose to complete a study based on that information. 

If the FDA approves the pre-clinical results and the companies plan for research, a Phase I trial can begin. This Phase involves 20-100 healthy volunteers. This phase assesses safety of the new product in humans and determines the dose to be used in future trials. This phase may take up to 1 year. 

Phase II would begin if the information collected in the Phase I trial gets approval to continue from the FDA. This phase includes 100-300 volunteers and determines safety and effectiveness of the new product. Typically in this phase, one group of volunteers will get the new product and one group will get a placebo, or sugar pill, medication. This phase may take up to 2 years. 

Phase III is 1000-3000 volunteers. This phase evaluates effectiveness, benefits, and possible side effects and compares the new product to current treatments. This phase takes several years. After Phase III studies, a company can request marketing approval from the FDA. 

There are also post-marketing studies, which are Phase IV. These trials will test volunteers not previously used, such as children or the elderly. These studies evaluate the long term effectiveness, the impact on quality of life and cost effectiveness compared to other available treatments.

All research doctors are called Principal Investigators. The doctors and their staff are monitored by the drug companies during a study to make sure that they are following proper procedures. 

Each study has strict guidelines for volunteers to be considered to participate. The study staff follows the protocol, or guideline for the study.

Being a volunteer in a study is free of cost to the volunteer. Volunteers may be compensated for their time. All study procedures (i.e. EKG’s, blood work, Physical examinations and breathing tests) are included in the study.

Researchers are governed by GCP, or good clinical practices. GCP is an international standard to:

· protect human rights in a research study

· ensure the safety and effectiveness of new products

· provides a definition of the role and responsibility of drug companies, doctors and research staff in the running of research studies

A volunteers safety is the number one concern.