What are Clinical Trials?

"Clinical Trials" is another name used for "research study". Most all drugs must first go through a process of testing and approval by the FDA before physicians are allowed to prescribe them. Volunteers are a very necessary component of this process because without their willingness to participate in drug studies, we would not have access to the medications that we have today. In addition, volunteers remain extremely important in future drug development in order to further science and our ability to find safer, more effective, or new treatments for various conditions.

The FDA has a system of testing that all drugs must go through after being tested on animals. This system consists of 4 phases, which you may read more about by clicking on the link in this sentence. After each study is completed, the data is submitted to the FDA for assessment. The FDA analyzes the data for safety and efficacy in order to decide if the drug can continue in the drug development process by advancing to the next phase or if all studies with the drug must stop.

Why participate?

Many people choose to participate in a clinical trial for one or several of the below reasons:

To help others/further science

• Whereas a current study may only be a stepping stone towards finding a treatment or cure for a condition, many volunteers find fulfillment in knowing that while they may not personally benefit from participation, future patients with the condition may benefit if a treatment/cure is eventually developed. Even the volunteer who participates in a trial in which he or she receives the placebo rather than the study drug is contributing important data to science.
• Studies frequently also need healthy volunteers to participate in order to advance science and therefore help others. Types of studies requiring healthy volunteers may be those in which the healthy patients serve as the "control group" being compared to a group with the specific condition. Another example in which healthy volunteers may be needed is a study that is focused on the prevention of a condition or disease.

To help the person's own condition or disease

• Many people may choose to volunteer in a particular study to help treat their own condition or disease. Some may have tried all available treatments on the market, and the study may offer access to a drug that is not yet available.
• Some studies may offer a drug that is currently on the market, but is being tested in a new delivery method (such as an oral pill rather than an injection).
• Volunteers may choose to participate in order to take a more active role in their own health care.
• Volunteers may also benefit from receiving expert medical care for the condition being studied, as he or she will be monitored very closely by a physician throughout the study.

How am I protected as a research participant?

If you are considering volunteering for a clinical trial, you may be wondering how you and your medical information collected during the study will be protected.

First you should know that your participation is voluntary and you may choose to participate or not participate in any study without it affecting the quality of care you receive from your physician who is conducting the research. In addition, study participants may choose to stop participating in a study at any time for any reason without penalty (while any data collected on the participant up to that point would be included in study results).

There are several systems in place in order to protect study volunteers and their medical information collected:

1. Informed Consent

Every study should have an informed consent, which is a document that describes your potential participation in a particular study. If you agree to participate, you will sign the last page and then be given a copy for your records. You should be provided with as much time as you would like in order to review this document, ask questions of study staff, and think about if you would like to participate or not.

The below items are typically included in this document in order that you may make an informed decision about study participation:

• purpose of the study, benefits, risks, requirements, study duration, compensation
• known side effects
• alternatives to participating
• participation is voluntary
• compensation in the event of injury
• withdrawal
• contact persons
• confidentiality/HIPAA statement

2. Study Staff

The physician conducting the research and all study staff will be monitoring your condition during the course of the study. They also protect the confidentiality of your research data, in addition to reporting and caring for any side effects you may experience.

3. Institutional Review Board

All studies must first receive approval by an Institutional Review Board (IRB) before the study can begin. The IRB is a supervising ethics committee that is composed of experts in the medical field in addition to community members.

The IRB's duties entail:

• Ensure the benefits of the study outweigh the risks
• Ensure there is no conflict of interest
• Ensure the research staff is credible
• Ensure the study will be conducted ethically
• Monitor the study for safety events

4. Sponsor/DSMB/FDA

The study sponsor (typically a pharmaceutical company), the Data Safety Monitoring Board of each study, and the Food and Drug Administration work together with the study staff to monitor each participant's safety in a study and to ensure the research is being carried out in an ethical manner.

Will participation cost me anything?

All studies pay for the medical services/testing required by that particular study, and therefore neither the volunteer nor his or her insurance is charged. The informed consent for each study should detail what will and will not be paid for (such as any injury resulting from participation, the cost of birth control if the study requires its use, etc.). Be sure to ask study staff if you have any questions.

Some studies offer a small reimbursement for the volunteer's time and travel expenses. Again, the informed consent for each study should describe if you will receive any payment during participation.

How can I get involved?

We welcome you to contact us with any questions concerning participation in one of our Current Studies as well as any future study we may have (479) 876-8205.

In addition, you may complete the Clinical Trials Interest Form on this website which we will use to determine the types of studies you may be interested in as well as if you would qualify for one of our current or upcoming studies.

Be a hero to someone and volunteer today!