The Walter Reed Army Institute of Research (WRAIR), based in Silver Spring, Maryland, centers its’ research attention on diseases that cause misery and suffering throughout much of the developing world not to mention pose material risks to U.S. military members abroad. As globally focused, targets for this unique investigational site include malaria, dengue, yellow fever, Ebola, leishmaniasis as well as viral hepatitis, infectious diarrheas and meningitis to name some examples.

Reporting for On Tap Magazine, Keith Loria recently introduced Washington DC metro readers to this venerable military-based research institution. Loria introduces the reader to Lt. Col. Melinda Hamer, MD, an emergency medical doctor by training and dedicated infectious disease investigator, who serves as director of WRAIR’s Clinical Trials Center (CTC). TrialSite News offers a breakdown of WRAIR for our audience.

Few Places like Walter Reed in the World

Ms. Hamer joined the WRAIR CTC in 2017, noting, “This is a unique place to be and there are really few places like it in the world.” Hamer continued “In addition to discovering and manufacturing new vaccines and drugs, we are able to conduct clinical research to assess candidates that have potential to combat some of the world’s most deadly pathogens. We like to say we address diseases from Anthrax to Zika.”

When was the Clinical Trials Center (CTC) Established?

Although WRAIR has a long history of conducting clinical trials, the CTC was born in 1992 to conduct highly regulated clinical trials to evaluate the safety of vaccine products as well as better understand how they work in combatting targeted diseases.

What kinds of Milestone Clinical Trials has WRAIR participated in?

WRAIR has had a significant influence worldwide thanks to its research operation. For example, it conducted trials supporting the approval of a therapy to treat Japanese encephalitis virus. This was helpful in protecting U.S. soldiers deployed in the Southeast Asian region—the vaccine is also commercially available. WRAIR clinical trials have contributed to approvals of several anti-malaria drugs—in fact all of the various malaria drugs in use today by the U.S. military “were touched in some way by researchers at WRAIR.

Moreover, upon the 2014-15 Ebola outbreak, WRAIR was selected as the first investigational site in the world to test the Ebola vaccine current in use to stop the current outbreak reports Lt. Col. Hamer.

CTC Director’s Role at WRAIR

Lt. Col. Hamer’s role as CTC Director really represents a rare honor to not only serve the country but also contribute to global research often targeting the poorest populations in need of immediate medical help. Hamer must ensure that clinical research is conducted safely and ethically for all involved. She helms a team of two dozen or so clinical research professionals including three doctors and eight research coordinators. Emphasizing the team-based nature of clinical research, roles and responsibilities must be filled with those that have the prerequisite experience, expertise and know-how—not to mention education and training—for the serious effort that clinical trials represent.

Planning, Organization and Discipline

Clinical trials require intensive planning and the more global and complex, all the more so. Tremendous amounts of planning go into a clinical trial and at WRAIR they conduct many trials simultaneously. Lt. Col. Hamer noted to On Tap Magazine’s Keith Loria that when managing a clinical trial portfolio, she must “constantly” conduct meetings with all the stakeholders and participants involved from study sponsors to the different roles involved with a given study—such as regulatory compliance.

Clinical Trial Portfolio at WRAIR CTC

At any given time, WRAIR is conducting 5 to 10 clinical trials at the WRAIR CTC. They are initiating new studies in 2020 and have completed at least 140 clinical trials.

Background

Walter Reed Army Institute of Research is the largest biomedical research facility administered by the United States Department of Defense (DoD). The venerable research institute is a subordinate unit of the U.S. Army Medical Research and Development Command (USAMRDC), based at nearby Fort Detrick, Maryland. It was named after Major Walter Reed, MD (1851-1902), the Army physician who, in 1901, led the team that confirmed the theory that yellow fever is transmitted by a particular mosquito species, rather than by direct contact.    

WRAIR hosts two Centers of Excellence for Military Psychiatry and Neuroscience and for Infectious Disease Research.

WRAIR CTC

WRAIR CTC has a proud history, since 1992, of conducting over 140 clinical trials, and has influenced the development of a number of vaccines and drugs currently on the market today. They conduct primarily FDA Phase 1 and 2 clinical trials of vaccine and drug products. They have also helped develop and conduct a type of clinical trial known as a Controlled Human Malaria Challenge (CHMI) model, which has become the gold standard in the field of malaria research.

Their current research is evaluating vaccines to fight malaria, Ebola, Zika, Marburg, dengue, HIV, and other infectious diseases. The CTC has focused capabilities which can pivot to high-priority Department of Defense and national security needs. On average, we conduct between 5 and 10 new studies per year.

Call to Action: Interested in participating in research at WRAIR CTC? See the link.

Source: On Tap Magazine

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