Clinical Trials are research studies conducted in human volunteers under very strict regulations to test if new drugs, vaccines, or devices are safe and effective. New medical products are first tested in laboratories, and often with animals, before testing is ever allowed with people. Two government agencies, the Food and Drug Administration and the Office for Human Research Protections, control or review every aspect of clinical trials to make sure they are as safe as possible and produce the crucial information necessary about the new product. The CTC must also follow military regulations controlling medical research with human volunteers.

Most of our clinical trials involve testing the safety and effectiveness of experimental products in healthy volunteers. Usually that involves the volunteer taking a medicine, receiving a vaccine, or using a medical device and then being carefully followed up with examinations and laboratory tests. Sometimes, clinical trials involve using a product and then being challenged to see how effective the product actually is. One example of such a challenge would be to have a volunteer use an experimental insect repellent and then exposing them to hungry mosquitoes to see if the repellent worked.

Vaccines can be made from dead organisms (like the tetanus vaccine), a highly weakened organism (like the measles vaccine), or synthetic copies of critical parts of an organism (like the hepatitis B vaccine). Most vaccines have two main components - the part (or parts) of the organism that is expected to trigger a specific immune response against that organism and an “adjuvant,” which is a general stimulator of the immune system. Vaccines can be given by mouth, as a shot, or even as a patch on the skin. You will be given complete information about each vaccine in the volunteer briefing and on the consent form, and you can directly ask the investigator any other questions that you have.

We study diseases that generally are not found in the United States but cause great harm in other parts of the world. Some of the diseases that have been studied at the CTC are malaria, dengue fever, leishmaniasis, as well as certain types of viral hepatitis, infectious diarrheas, and meningitis.

Every new product approved for testing in humans has first gone through years of testing in the laboratory and often with animals. All of these studies are carefully reviewed by the Food and Drug Administration and other regulatory authorities before human testing may be considered. Research studies at the CTC are only conducted under strict protocols which have been approved by scientific and ethical review committees. Every trial is conducted by trained and qualified doctors, nurses, and scientists. Every trial is independently monitored for ethical and regulatory compliance, as well as volunteer safety, at every stage. All of these products are experimental and there is some risk with each one.

You have the right to be fully informed of those risks and ask questions about how you will be protected. You also can be confident that all of the staff working in the CTC consider your safety to be our number one priority and we will do everything we can to ensure it. If you do have any side effects from participating in a trial, you are entitled to free medical care to treat the problem.

You will receive a medical evaluation and laboratory work prior to participating in a clinical trial. Also, you have the satisfaction of being a crucial part of medical research that may be of great benefit to all people.

Financial compensation is frequently provided to volunteers in our studies for the time and effort of their participation.

Each study is different. In the past we have had studies that ranged from a single day to several years. On average, however, our studies last several months, and require multiple visits.

We are committed to protecting the privacy and confidentiality of our research participants to the fullest extent possible. All of our studies make use of multiple security precautions designed to maximize participant confidentiality, such as use of numbers rather than names and secure databases. Access to study records is limited to authorized personnel only.

Watch for our advertisements and give us a call or email us so that we can contact you with information about current trials that you may be eligible to participate in. If you are interested in participating in a study, we will then arrange for you to come to the CTC for a screening visit (see below for a description of a screening visit). Before you enroll in a study, you must be sure that you are able to come in to the CTC for all of the visits required for the study. The study cannot produce meaningful results if volunteers do not come in for the necessary visits. You will be given a schedule of when the visits will occur so you can make arrangements for your time and transportation, and we will be as flexible as possible when unexpected events arise.

If at any time during a study you feel you are unwilling or unable to continue, you may withdraw your consent and discontinue participation. The information collected during the study will continue to be maintained in a confidential manner. You may be asked to complete one or more safety visits, in which no research information is collected, to ensure your health.

There is no expense for treatment or being involved in a study other than your transportation to the clinic.

When you volunteer for a study, the first visit you will make is called a screening visit. In this visit, the study personnel will collect information that will determine if you are eligible to participate in the study. A typical screening visit will consist of the following, although the information collected can vary from study to study:

• Sign in at Front Desk
• Briefing
• Consent Form
• Comprehension Assessment
• Medical History
• Vital Signs
• Screening Physical, Basic
• Blood Draw and Urinalysis

To get on post you will need to present a gate guard with a valid government (state or federal) picture ID. Anyone traveling with you will also be required to present a valid ID. Preferred forms of ID include military ID cards and state issued driver's license. If you are driving to WRAIR, a valid registration is required for the vehicle. As security procedures are subject to change at short notice, it is a good idea to check with us before each visit to ensure requirements have not changed.

The Clinical Trials Center is part of the Walter Reed Army Institute of Research (WRAIR), located in Silver Spring, Maryland. The WRAIR campus is readily accessible by car, and is convenient to multiple forms of public transportation.

For maps, directions and other transportation questions, please call 301-319-9660.