Understanding Capacity Building at Vaccine Trial Sites
How can AIDS vaccine trials help build infrastructure and capacity in developing countries?
In order to determine whether an AIDS vaccine candidate is effective it must be tested in the populations that are most affected by the disease. Clinical trials have to take place in communities where there is a high enough incidence of HIV infection for researchers to determine positive benefits from the vaccine. This often requires running trials in developing countries, where there is the highest HIV/AIDS burden. It is also essential that vaccines be evaluated in the communities that need them the most.
Many organizations involved in AIDS vaccine research, including the Global HIV Vaccine Enterprise and the European & Developing Countries Clinical Trials Partnership (EDCTP), have recently published reports emphasizing the importance of developing both the physical infrastructure and the human resources at clinical trial sites in developing countries. This is the strategy used by organizations like Walter Reed Army Institute of Research, the US Centers for Disease Control and Prevention, and IAVI that have been running vaccine trials in Africa and Asia. The idea of building trial site capacity involves both establishing clinics and laboratories and training medical professionals. Both of these steps help ensure that the research site is sustainable over the long term and can be used for future clinical trials. Developing these sites also benefits the community by providing career opportunities for healthcare workers that can serve the community long after the trial ends or by attracting other medical services to the area, such as HIV treatment programs (see VAX February 2006 Primer on Understanding the Benefits and Risks of Participating in Clinical Research).
The first step in building an AIDS vaccine clinical trial site involves constructing the actual buildings that will serve as clinics and laboratories or modifying those that already exist. These facilities are then equipped with the instruments necessary to process laboratory samples obtained from volunteers during the trial and preparing these specimens for storage or shipment. Some sites may even develop sophisticated HIV immunology and virology laboratories that can analyze samples and process the data from the trial in the country where it takes place.
India recently started an AIDS vaccine trial sponsored by IAVI in partnership with the Indian Council of Medical Research and the National AIDS Control Organization at the Tuberculosis Research Center (TRC) in Chennai. The TRC, a newly-established center of excellence for the clinical evaluation of vaccines in the country, features a safety and immunology laboratory where all laboratory tests will be run.
Once the clinics and laboratories are established it is also important to build human capacity at AIDS vaccine trial sites. Sponsor organizations spend significant amounts of time hiring and training medical professionals in developing countries to handle the activities associated with the trial.
This occurs through a series of instructional workshops that cover all aspects of the clinical trial process, from screening and enrolling volunteers to collecting and analyzing data, and are based on a set of work practices developed specifically for each site. All trials are certified according to a set of international guidelines, known as Good Clinical Practice (GCP). Compliance with GCP guidelines ensures that the trial is run properly, that the rights and needs of the volunteers are protected, and that the data collected during the trial is of high quality.
Counselors and nurses are trained to work with potential volunteers and to administer the informed consent process (see VAX June 2005 Primer on Understanding Informed Consent). These individuals may also receive specialized training on enrolling women in AIDS vaccine trials and other gender-related issues.
For the staff working in the laboratories the training includes how to handle and process the laboratory samples and the procedures for data management. All tests run in the laboratories are verified by quality control processes to ensure that the results of the trial are meaningful.
The process of site development continues even after the trial has started. Many organizations continue working to enhance the site's ability to deliver HIV prevention and treatment services and to provide referrals to other clinics in the community. This can involve additional training sessions or meetings arranged with the staff from other AIDS vaccine clinical trial sites in order to learn from shared experiences.
Providing the site staff with such extensive training helps strengthen the human resources in that community. Once the trial is complete, these medical professionals can work in many other areas, including research, nursing, or in conducting other clinical trials.
Sustainable trial sites
Developing both the physical infrastructure and human capacity at a site are necessary steps for conducting an AIDS vaccine clinical trial in developing countries, but once established these sites can continue to function well beyond the end of the current trial. The staff's expertise in HIV could make the site suitable for other types of HIV prevention trials, including trials of microbicides, or for clinical research studies that contribute to the understanding of the HIV/AIDS epidemic in that country. These sites may also attract HIV treatment programs or other healthcare services that can continue adding benefit to the community. Keeping these sites active is also of great interest to organizations sponsoring AIDS vaccine trials, since many vaccine candidates will need to be evaluated in the future and these trials will require experienced sites and surrounding communities that have successfully conducted past trials.