A clinical trial is a research study to answer specific questions about vaccines, new therapies, or new ways of using already known treatments. Clinical trials (also called medical research or research studies) are used to determine whether new drugs or treatments are safe and effective. Carefully conducting clinical trials is the fastest and safest way to find treatments that work.
Ideas for clinical trials often come from the minds of medical researchers. Once researchers test new therapies or procedures in the laboratory and see promising results, they begin planning clinical trials. New therapies are tested on people after laboratory and animal studies show safe and promising results. All medications on the market have gone through several phases of extensive clinical trials before being released to the public. In fact, many medications used today are the product of years of in-depth research. Advanced Research Institute helps conduct the trials. We conduct phase 2, phase 3, and phase 4 clinical trials.
What are Clincal Trial Phases?
Clinical trials of experimental drugs proceed through four phases:
- In phase 1 clinical trials, researchers test a new 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 2 clinical trials, the 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 3 studies, the study drug or treatment is given to large groups of people (1000-3000) to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase 4 sudies are done after the drug / treatment has been approved and marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and side effects associated with lond-term use.
What protections are there for participants in clinical trials?
The government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and worth and potential benefits.
An IRB is an idependent committee of physicians, statisticians, community advocates, and others to ensure that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews research.
Do you currently or have you ever taken prescription or over the counter medication? Does someone in your family or someone you know take medication routinely?
These are two simple questions that get to the foundation of clinical research. If you answered “yes” to either of the above questions, then you or someone you know has benefited from clinical research. Each prescription and over the counter drug has to go through the research and development process prior to being approved by the FDA for use in the general public.
There are several benefits to participating in clinical research. Some of these benefits include:
- Taking an active role in your own health care.
- Gaining access to new treatments that are not available to the public.
- Obtaining expert medical care at leading health care facilities during the trial.
- Helping others by contributing to medical research.
If you are interested in receving more specific information about clinical trials we are conducting, please click here. One of our clinical research coordinators will contact you within two business days to answer any questions you may have.