BENEFITS OF BEING A RESEARCH VOLUNTEER

The benefits of study participation may include:
Study-related exams at no cost
Study medication (possibly placebo)
Reimbursement for time and travel expenses for most studies
Contributing to the development of new therapies and learning more about a medical condition and treatment options

FACTS ABOUT BEING A RESEARCH VOLUNTEER

Our network of outstanding board-certified physicians investigators and professional research coordinators are committed to providing superior service to our patients. (About our Doctors)

Participation is confidential. We do not share personal patient information from our database with any outside individuals or companies (HIPPA and Privacy Policy).

Subject safety and well being is a key concern. An accurate and complete medical history is required to ensure safety as well as to determine if the person is an appropriate study match. (Volunteer Eligibility)

Length of participation varies. Some studies may last 4 weeks while others can last up to 3 years. Participation in clinical trials is limited to one study at a time with at least 30 days between each study.

Study opportunities may vary each week. You may not qualify for a particular currently enrolling study. However, the following week there may be a similar study (or in the future) with different eligibility criteria. (CURRENTLY ENROLLING STUDIES)

The use of placebo (inactive substance) in trials. Not all studies have a placebo control group. In some studies all subjects receive active medication. Some studies elevate medications that are already FDA approved, while others are still in the latter phases of testing. Our clinic is not a standard Phase I facility, as most of our studies are in the latter phase of testing.

VOLUNTEER ELIGIBILITY

Participation in a clinical trial is based on inclusion/exclusion criteria. Some studies require a person to have a specific condition with specific symptoms, while others are for healthy individuals interested in preventative care.

PHASES OF MEDICAL RESEARCH

Medical research or clinical trials are divided into a few different phases. Each phase has a different focus, but all work towards the goal of finding a new or improved treatment. These phases include:

Phase 1 Clinical Studies
In Phase 1, a new drug or treatment is tested on a small group of people -- usually about 20 to 80. The new treatment has already been tested for safety in the lab and in animals, and has shown to have good potential for helping people. It has also been submitted to a government regulatory agency and approved for use in human testing.

The purpose of this phase is to find out if the treatment is safe for humans, and if so, how much should be given and how. Those who participate in this phase are watched very closely (usually requires overnight stays), and the researchers record and study any side effects that happen after taking the study drug.

Phase 2 Research Studies
In Phase 2, a larger group of people receives the drug or treatment. There can also be a placebo group that does not receive the new treatment. The main purpose of this phase is to find out whether or not the new treatment is actually effective in treating the patient's disease or medical condition. The safety of the drug or treatment continues to be studied in this phase, and any side effects are carefully reviewed.

Phase 3 Studies
A large group of people are involved in Phase 3 studies. Those who participate in Phase 3 are usually randomly assigned to different groups. In one group, up to a few thousand people will receive the new treatment.

Another group receives the standard treatment for the same medical condition, or receives a placebo. This is called the "control" group. The side effects and treatment success in people receiving the new treatment are compared to those in the control group. This helps the researches know if the new treatment is really safer and more effective.

During this phase, researchers will continue to collect information about side effects, and also study how often the condition returns and the effects of the treatment on the patient's quality and length of life.

After Phase 3 studies are completed, a medicine can be submitted to the government for final approval.

Phase 4 Research Studies
Once a new treatment has been approved, there may be additional clinical studies performed. These are called Phase 4 studies. These studies are conducted for a number of reasons. One of these is to find out how effective the treatment is in different groups of people -- such as those of the same race or age group. Another is to see if the treatment can be more effective if administered in a different fashion. For example, a pill can be changed to a topical cream for a more direct approach to muscle/joint pain. Information is also gathered about long-term effects of the treatment.

IRB PROTECTIONS

Each clinical trial is approved for suitability by an Institutional Review Board (IRB) comprised of professionals from the fields of medicine, religion, law, and education. The IRB’s function serves to protect the safety and rights of volunteers in clinical trials.

HIPAA REGULATIONS

New privacy regulations ensure privacy protections for patients by protecting medical records and other individually identifiable health information, whether it is on paper, in computers or communicated orally. To learn more, visit www.hipaa.org.