The Baltimore Research and Education Foundation is proud to play a role in enhancing the lives of Veterans who have bravely served our country through transformative biomedical research and education.

BREF works with Veterans and physicians who are part of the VA Maryland Health Care System, Hershel Woody Williams VA Medical Center in Huntington West Virginia, Louis A Johnson VA Medical Center in Clarksburg West Virginia, and the Hampton VA Medical Center in Hampton Virginia.

Veterans volunteer for clinical trials for various reasons. Many do it for altruistic reasons to improve medical care for veterans, families and the general public. Some have serious or life-threatening illnesses, and a clinical trial allows them to access cutting-edge therapies not yet widely available. Click the “Active Clinical Trials” button below to go to our Research page for a list of trials currently being administered by BREF at the VA medical centers we serve.

WHO SPONSORS CLINICAL TRIALS AND WHY?

Clinical trials can be sponsored by biomedical and pharmaceutical companies, research foundations, or government agencies such as the National Institutes of Health or the Department of Defense. Sponsors conduct clinical trials for many reasons. Often they are studying the benefits of a new drug, treatment, or medical device to improve disease, illness, or disability. Sometimes clinical trials may be investigating the use of a currently available medical treatment for an alternative or broader use.

WHO PROTECTS YOUR RIGHTS?

In the US, all clinical trials require approval of an Institutional Review Board (IRB). The IRB serves as the patient’s advocate and makes sure all appropriate assurances are in place to protect the rights and privacy of patients participating in clinical trials. The IRB reviews all study methods to ensure the scientific design minimizes risk and that documentation provided to the participants accurately inform them of the nature of the study. Additionally, the IRB will monitor the study throughout it’s life cycle.

WHAT IS INFORMED CONSENT?

Informed Consent is a document provided to study participants, written in layman’s terms, that provides information about expected effects of the study, risks involved, treatment plans, and rights of the participant. When receiving informed consent, the patient is also given the opportunity to ask questions and discuss concerns with study personnel. Participants should not sign the Informed Consent form until all questions have been answered satisfactorily. Once signed, the Informed Consent serves as documentation to the IRB and the FDA that the participant understands what the study is about and that they have been informed of potential risks, they understand their treatment options, and that they have the right to leave the study at any time.

WHAT ARE THE RISKS?

Before the testing of a new drug on humans can be conducted, the study sponsor will have done extensive laboratory and animal testing on toxicity and dosage tolerance. Once approved to move into human testing, studies are designed in three phases.

• Phase I studies assess the safety and potential side effects of a new medical treatment in humans. Although these treatments have been tested in the lab and animal studies, side effects in people can’t be known until Phase I studies are performed.

• Phase II studies are performed to see if a new medical treatment works for a particular disease or illness. Often Phase II clinical trials look to see if people receiving the new treatment have improved outcomes or live longer than those with the same diagnosis who did not receive the treatment.

• Phase III trials are performed to determine if a new medical treatment is more effective or better than the current standard treatment. These trials often include a large number of patients and may be conducted at many locations across the country or even the world at the same time. Placebos may be used in Phase III clinical trials but are not usually given alone if there is a current treatment available that works.

WILL YOU GET THE PLACEBO OR THE NEW DRUG?

Many Phase II and III trials include a placebo. Patients are typically chosen randomly to participate in either the drug group or the placebo group, so it’s important to understand when choosing to enroll in a study that if you are hoping to get access to a new treatment you may or may not actually receive the experimental drug. Often your doctor won’t even know if you are receiving the trial drug or the placebo until the study ends. Sometimes a patient who was randomly assigned to the placebo group for part of the study, will at some point be offered the new treatment being studied as well.

OTHER CONSIDERATIONS

There are several pluses and minuses to participating in a clinical trail. Here are a few additional things to consider.

• While safety and minimizing side effects is of utmost importance in clinical trials, no treatment or procedure - even one already in common use - is without risk.

• Participation may involve extra time and effort (e.g. additional trips to VA).

• There may be additional medical procedures (e.g. blood draws) required.

• You may have to be taken off other medications during the study.

• After a trial ends you may not be able to continue to have access to the drug until/if it gets approved by the FDA.

VA HEALTH CARE

www.oefoif.va.gov

This website serves as an excellent introduction to getting health care through the Department of Veterans Affairs. This link is specifically designed for returning OEF / OIF veterans.

REAL WARRIORS

www.realwarriors.net/

Promoting the processes of building resilience, facilitating recovery, and supporting reintegration of returning service members, Veterans and their families.

DEFENSE CENTERS OF EXCELLENCE FOR PSYCHOLOGICAL HEALTH AND TRAUMATIC BRAIN INJURY

www.dcoe.health.mil/

Whether you are an active duty, National Guard or Reserve warrior, or one of our nation’s Veterans, DCoE can assist you in finding the answers to your questions about psychological health and traumatic brain injury.

NATIONAL CENTER FOR PTSD

www.ptsd.va.gov/

Advancing the clinical care and social welfare of America's Veterans through research, education, and training in the science, diagnosis, and treatment of PTSD and stress-related disorders.

MILITARY ONE SOURCE

www.militaryonesource.com/

A 24/7 resource for military members, spouses and families

VET CENTERS

www.vetcenter.va.gov/

U.S. Department of Veterans Affairs Vet Centers provide readjustment counseling and outreach services to all Veterans who have served in any combat zone. Services are also available for their family members for military related issues. All services are provided at no cost to the Veteran or the family.

FOR WOMEN VETERANS

www.publichealth.va.gov/womenshealth/about.asp

Information on health care services available to women Veterans, including comprehensive primary care as well as specialty care such as reproductive services, rehabilitation, mental health, and treatment for military sexual trauma. You can also find answers to some of the most frequently asked questions about women Veterans health care.

UNIFORMED SERVICES JUSTICE & ADVOCAY GROUP (USJAG)

www.usjag.org

For veterans and soldiers with OTH and BCD discharges linked to combat stress, USJAG offers advocacy and direct services.

LGBT VETERNS

Each VA facility has a local LGBT Veteran Care Coordinator (VCC) who is appointed by their facility leadership. The VCC is responsible for promoting best practices for serving LGBT Veterans and connecting LGBT Veterans to services.

baltimore, MD: www.maryland.va.gov/services/lgbt

Clarksburg, wv: www.clarksburg.va.gov/services/lgbt

Hampton, VA: www.hampton.va.gov/services/lgbt

huntington, VA: www.huntington.va.gov/services/lgbt

CAREGIVER SUPPORT SERVICES

VA offers a number of services that can provide you with the support that's right for you. Whether you and the Veteran you care for could use some help at home or you just need someone to listen, we're here to support you. Follow the link to learn more about the variety of services available to Family Caregivers.

baltimore: www.maryland.va.gov/services/caregiver

Clarksburg, wv: www.clarksburg.va.gov/services/caregiver

Hampton, VA: www.hampton.va.gov/services/caregiver

huntington, VA: www.huntington.va.gov/services/caregiver

NATIONAL INSTITUTES OF HEALTH

www.nih.gov

The National Institutes of Health website provides current information and resources relating to many aspects of health and disease.