Fisher BioServices supports clinical trials in numerous ways, including acquiring and distributing clinical agents and the design and assembly of biospecimen collection kits. Recently, the staff members at the Clinical Agent and Specimen Repository (CASR), which Fisher BioServices operates for the National Institute of Allergy and Infectious Disease (NIAID) at the National Institutes of Health (NIH), were challenged to support a particularly unique clinical trial: The efficacy of fluconazole in the treatment of Valley Fever.
Valley Fever is a fungal infection caused by Coccidioides immitis, which is endemic to the desert soil of California, Arizona, and similar regions of South America. The majority of those infected with the fungus experience flu-like symptoms that quickly resolve. However, in a small subset of those infected, the fungus spreads to the skin, skeletal system, and the brain, causing debility and occasionally, death. Although it is classified as a rare disease based on the total number of cases nationwide, the illness is a substantial burden to the residents of Arizona and California.
At present, there is no established treatment protocol for Valley Fever, in either people or in dogs, which are three times more susceptible to the infection. Patients are typically given fluconazole, a triazole antifungal approved to treat Candidiasis, Cryptococcal and other fungal infections. However, the correct dosage and other parameters have not been established for treatment of Valley Fever, and the response rate, as well as the relapse rate, is highly variable.
The illness has been the primary concern of three organizations: the Coccidiomycosis Study Group of San Francisco [www.coccistudygroup.com]; the Valley Fever Americas Foundation in Bakersfield, California [www.valleyfever.com]; and the Valley Fever Center of Excellence at the University of Arizona in Phoenix. In 2013, the three groups came to the Centers for Disease Control and Prevention (CDC) and the NIH for help.
In response to their request, the NIH worked with multiple collaborators to design a phase IV clinical protocol to determine whether or not fluconazole is really effective in reducing the symptoms and severity of Valley Fever. The study will also help define parameters for early detection and test whether early treatment can reduce the severity of symptoms and possibly eliminate the development of the more chronic, debilitating forms of the illness.
The Challenge: Complex kit production and distribution to clinical sites
As the primary support team for NIAID infectious disease-related trials, Fisher BioServices’ CASR staff members were tasked with supplying fluconazole and matching placebo for use in the study, as well as for creating kits for biospecimen collection. In addition, the facility would receive, process, and then ship many of the patient specimens to specialized laboratories for analysis.
A primary challenge was the nature of the clinical sites. Patients were being recruited from community-based doctor’s offices and clinics, which are not traditionally involved with clinical trials and are often unfamiliar with their special requirements. For this reason, study leadership asked the CASR staff to design online training modules for using the web based Order-It clinical agent ordering system, to assist clinic staff in ordering clinical agents and supplies and complying with regulatory requirements.
Another challenge was managing the difficult balancing act between always having sufficient kit supplies and clinical agent inventory on hand, versus wasting these resources due to expiration dates. This is of course dictated by the rate of study subject enrollment. However, at the onset of many clinical studies there is no way of accurately estimating how many participants will enroll, or when. My team and I had to juggle 31 different collection kit components and clinical agents, each with its own expiration date. This situation then cascades down through a complex timetable for re-ordering components, setting up kit production runs, and generating the associated quality/regulatory documents.
To read more about the Fisher BioServices teams' solutions to these challenges, as well as the results, download your free copy of our Case Study Cooling Valley Fever: Unique Kits for a Unique Clinical Trial.