Vaccine trials: Today at the World Vaccine Congress, Dr Ellen Vigdorth presented about the critical role of epidemiology, temporal requirements and local customs integration into design, planning and delivery for successful vaccine trials.
Historically, clinical trials in North America and Europe were very organized, according to Dr. Virgdorth. Now, as many studies have moved into the Southern hemisphere and Asia, there is a need to re-examine how trials proceed. Many investigators are comfortable conducting vaccination campaigns, but not conducting clinical trials and many trials are built around patient care centers that are not equipped for clinical trials so infrastructure needs development.
In the Northern Hemisphere, we are doing direct-to-patient recruitment. When we go into new areas of the world, you need community awareness campaign to ensure sensitivity to local culture.
In response to this need, Quintiles began a clinical research apprentice training program in South Africa in 2009 which is being implemented by a local youth development company.
Quintiles is also creating global SOPs, global processes, global tools/ applications and eTraining to facilitate standardization and learning in multi-country settings.
Check back here in a couple of days for the full presentation. Excellent presentation Ellen!