Frequently Asked Questions

What are clinical trials?

Clinical trials are an important step in the process of medical research as an effort to find ways to prevent or treat different diseases. They may involve vaccines, medicines, or medical devices and rely on people like you to help. At the WRAIR CTC, we focus primarily on vaccines and medications.

Clinical trial studies are conducted in volunteers under very strict regulations and guidance from the Food and Drug Administration and the Office for Human Research Protections to ensure the trial is safe with the least possible risk to volunteers. At the CTC, we also must follow military regulations regarding human research.

Learn more about: The FDA's drug review process and Human research protections.

What are the phases of clinical trials?

Every clinical trial goes through different phases from start to finish. It can sometimes help to think about the types of trials as early (Phases I and II) and late stages (Phases III and IV).

Phase I: "First in human" trials usually involve 20–100 healthy volunteers to assess safety and side effects.

Phase II: Trials involving 100–300 participants evaluate the treatment’s effectiveness, determine the best dosage, and gather additional safety information.

Phase III: Larger studies (300–3000 participants) compare the new treatment with standard ones to verify its effectiveness and further assess safety.

Phase IV: Post-marketing studies that monitor long-term safety and benefits after the treatment is approved by the FDA.

What is informed consent?

Informed consent is a process that provides you with all the important information about a clinical trial before you decide to participate. You will review study details, ask questions, and receive a document explaining the study’s purpose, procedures, risks, benefits, and contact information. If you agree to participate, both you and a study staff member will sign the form, and you will keep a copy for your records. Participation is completely voluntary, and you can withdraw at any time without penalty.

What are vaccines?

Much of the work at the WRAIR CTC involves developing vaccines to prevent various diseases. Vaccines help your body produce antibodies that protect against infections. Normally, your immune system creates antibodies when it first encounters a germ, but vaccines stimulate antibody production without causing the disease. If you are later exposed to the germ, your body is prepared to fight it off.

How do I get involved?

Actively recruiting studies can be found here.

What questions should I ask if I'm eligible to participate?

If you are considering enrolling in a clinical trial, here are some questions you might ask:

• What is the study about and why is it important?
• What kinds of tests or treatments will I undergo?
• What are the potential risks, side effects, and benefits of participating?
• What are my responsibilities during the study?
• What will happen during the study visits?

Will I be safe?

Clinical trials are crucial for advancing medicine. Before involving human participants, every new treatment undergoes extensive lab and animal testing. All studies at the WRAIR CTC follow strict protocols approved by the FDA and ethical review committees, and are monitored by qualified professionals. If any side effects occur, you will receive free medical care.

Learn more about: The FDA's drug review process and Human research protections.

Will my confidentiality be protected?

We are committed to protecting the privacy and confidentiality of our volunteers. Study records use participant numbers rather than names and are stored in secure databases accessible only to authorized personnel. We follow strict HIPAA standards to ensure your information remains private. Learn more about HIPAA protections.

What if I enroll but change my mind later?

Each study has its own set of tests and questionnaires that you will complete during your participation. In the lab, you may have access to a lounge area with cable TV, a DVD player, board games, and you may bring personal activities like books or games. However, electronic devices such as phones or laptops will be securely stored during your session. Unless there is an emergency, you will not be able to contact friends or family while in the lab—so please notify your loved ones beforehand.

What’s the benefit to volunteering for clinical research?

At your initial visit, you receive a comprehensive medical evaluation and routine lab work, with any significant issues addressed immediately by a physician. In addition to thorough health monitoring, you contribute to important research that may lead to breakthrough treatments and improved public health.

What kinds of diseases do you study?

We study various infectious diseases that affect both Soldiers and the public. Our research focuses on diseases such as Zika, Ebola, malaria, dengue, chikungunya, and HIV.

How do I get onto the military base?

To enter the military base, you must present a valid government-issued (state or federal) photo ID at the gate. Anyone accompanying you must also have a valid ID. Preferred forms include military IDs or state-issued driver's licenses. If you are driving to WRAIR, a valid vehicle registration is required. Since security procedures may change, please call our front desk at 301-319-9660 before your visit to verify current requirements.