Investigators face several technical, logistical, and cultural challenges when conducting vaccine trials in developing nations.
At the 2010 World Vaccine Congress in Lyon, France, Renee Moore, President of Corporate and Strategic Development, Encorium Germany, GmbH, discussed the challenges of performing clinical trials in emerging markets. Encorium is a global clinical research organization (CRO) with experience in conducting vaccine trials, having successfully managed more than 70 vaccine trials, involving more than 115,000 subjects at 621 international sites in 20 host countries.
Moore said that there are no real differences in the standards of clinical trials carried out in developed countries versus developing countries. Investigators in either setting “will not compromise the safety of study subjects” and are required to “adhere to the scientific precision of the protocol,” Moore said. However, vaccine trials are not like other clinical trials. “One of the major differences with vaccine trials, regardless of where they are performed, is the large subject cohorts that are recruited in a relatively low number of sites, in a short period of time. We all know that if something can go wrong it will go wrong, and that can be disastrous for a vaccine trial. The speed is too fast to make corrections according to a conventional monitoring schedule,” explained Moore. Other challenges encountered when conducting vaccine trials include the unique logistics with trial sites and with “cold chain,” the often at-risk patient population, rapid patient recruitment results that are required in order to anticipate and respond rapidly to any issues that may arise, and monitoring schedules that should be set up to mirror subject recruitment.
Vaccine trials in emerging markets are even more challenging, said Moore. The infrastructure in many participating countries is underdeveloped, “which can make it difficult for a CRO that needs to create capacity, forcing investigators to work under non-ideal conditions, which often requires time, flexibility, and creativity.” Management of the trial requires not only an expert in vaccine clinical trials, but also expertise in managing people from different cultures; for example, Moore said “it is important to understand the cultural sensitivity of hierarchy and manage working relationships with the principal investigator, who is often a key opinion leader.” There are also ethical considerations such as ensuring patients’ freedom to refuse to participate in a trial. Trial managers must also ensure that participation in a trial is not perceived as the sole option for assessing appropriate healthcare (the process may be impacted by social organization, family structure, languages, and literacy). Other issues which can have an effect on clinical trials in developing countries include limited material and human resources; limited access to healthcare for patients, impacting their ability to refuse participation; medical issues (eg, co-existing morbidities), the importance of children in infectious disease research; and various cultural factors (eg, identification of newborns, relative importance of children’s well-being, vulnerable populations like women and “street children”).