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 trials 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.
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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 trials are one of the earliest stages and referred to as “first in human” trials. Generally, they involve studying a drug or treatment in a small group (20-100) of healthy volunteers. The point of this type of study is to determine if the drug or treatment is safe and to see if it has any side effects.
Phase II trials are also part of the early stage in the clinical trial process. They involve a larger group of participants, usually groups of 100-300 people. The goals of phase II trials are to determine if the drug or treatment is effective, what the best dose is, and to gather more information about safety and any adverse effects.
Phase III trials are a very important step in development of a new treatment or medical device. These studies involve much larger groups of people (300-3000). These studies are key to establish just how effective the new medicine, vaccine, or device is truly effective will be and therefore if it will be useful for doctors and patients to combat disease. This is done by comparing the new product with the “gold standard” or similar treatment currently being prescribed (i.e. medication) or used (i.e. heart valve) as part of the study. Safety and side effect information is collected as well.
Phase IV trials are the final phase also known as “post-marketing surveillance” or, less formally, a “confirmatory trial.” This type of study happens after the FDA has approved a new treatment or device for use to the public. Research staff will collect safety data and information about benefits of the new product to help determine how it can best help people.
Informed consent is a process to give you important information to consider before you agree to participate in a clinical research study. The study team will explain the study to you and answer any questions you have. You will also get an informed consent document that has all of the information about the study, including why it’s being done, what tests and procedures are involved, risks and benefits of participating, and contact information for the study staff. Please take time to make your decision.
To give informed consent, you should know that:
- You will be given detailed information about the research study.
- You are free to ask any questions that will help you understand the study.
- You will be asked to read, sign, and date the informed consent form after you have an understanding of the study and decide if you would like to participate. You do not have to complete this on the same day you receive the form.
- Taking part in this study is completely voluntary. If you do not want to take part in the study, there will be no penalty or loss of any benefits to which you are otherwise entitled.
- You may withdraw from the study at any time without penalty or loss of benefits to which you are otherwise entitled.
- You will be given a signed and dated copy of this consent form to keep.
- A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by US law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
At lot of the work we do at the WRAIR CTC involves developing vaccines to prevent many different diseases. Vaccines help your body to make the antibodies to protect against different diseases. Antibodies are made by your immune system when your immune system sees a germ (such as a virus or bacteria for example) for the first time. The next time your immune system sees the same germ it “remembers” the virus (or bacteria) and releases the previously-made antibodies that protect against the germ. This occurs naturally in people when they are infected with a germ, but the disease can make someone very sick or cause death. Vaccines work to help the body make the antibodies without the person actually having the disease. They send a message to the immune system to make the antibodies to a specific germ. If a vaccinated individual is then exposed to the actual germ, the protective antibodies are released into the blood and prevent the disease.
Actively recruiting studies can be found here.
If you want to enroll in a trial, you should get as much information as you can before you make your decision. You will receive written information about the study at your first visit to the clinic; questions are encouraged and welcomed. Below is a list of questions volunteers often ask study doctors and clinical trial staff:
- What is the study about and why is it important?
- What kinds of test of tests or treatments will I have during this study?
- What are the possible risks, side effects, and benefits if I participate in this study?
- What are my responsibilities?
- What will happen during the visits?
Clinical trials are an important part in the advancement of medicine and science. The primary goals of clinical research are to develop new medicines, vaccines, treatments, and devices to help cure disease. The only way to find out of a new medicine or vaccine is safe and effective is to test it out on people in clinical trials; volunteers are vital to the development of new, lifesaving treatments. Every new product has gone through years of rigorous testing in the lab and in animal models before it is approved to move forward for research involving people. All clinical studies are carefully reviewed Food and Drug Administration and other regulatory authorities before people may be recruited to participate. All studies at the WRAIR CTC are conducted under strict protocols that are approved by ethical and scientific review committees. Every trial is conducted by trained and qualified doctors, nurses, scientists, and other medical personnel and is independently monitored for to ensure volunteer safety as well as ethical and regulatory compliance for the duration of the study. You have the right to be fully informed of any possible risks related to study participation and ask questions about those risks and about how you will be protected. If you experience any side effects from participating in a clinical trial, you will received free medical care to treat the problem. You can be confident that the CTC staff considers your safety our number one priority and we will do everything we can to ensure it.
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We are committed to protecting the privacy and confidentiality of our volunteers to the fullest extent possible. All of our studies use 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 and we follow strict standards set forth by the Health Insurance Portability And Accountability Act of 1996 (HIPAA). Learn more about HIPAA protections here.
At any time during a study, if you feel you don’t want to participate or you are no longer able to, you don’t have to. You may withdraw your consent and leave the study. There is no consequence to you for this. The information collected during the study will still be kept confidential. The CTC staff may ask you to return to clinic for one or two more visits to check safety labs and to see how you are doing. This is done to make sure you stay healthy; there is no research information collected at these visits.
At your very first visit, you will get a full medical evaluation and have routine lab work done to check your health. Blood work is regularly monitored during the course of a study as part of ensuring your safety. Significant abnormalities will be reported to you immediately and you will receive counseling from a physician. Also, you have the satisfaction of being a vital part of medical research that may be of great benefit to people throughout the world.
We focus on many infectious diseases that cause great harm both to Soldiers and the public. Some of the diseases we are interested in include: Zika, Ebola, malaria, dengue, chikungunya, and HIV.
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. Just call our front desk at 301-319-9660.