OCT is opening additional 7 sites for a study in acute bronchitis. The study has been active at OCT since 2011. Since then we have enrolled up to 110 patients at 7 sites. The client decided to open additional sites in Russia to meet their enrollment targets of 600 patients with acute bronchitis worldwide. OCT is conducting site selection and site initiation visits at the moment. OCT choice of sites is based on our prior experience with the sites.
The study is conducted in children with acute bronchitis. Study drug is a unique herbal combination extensively tested for effectiveness supporting the lower respiratory system. The drug is already used in Russia, Europe and the USA. This is a randomized, double blinded, double controlled multicenter study with active control in groups. The study is conducted in patients aged 2-6 years. This is a pediatrics study. OCT has good clinical research experience in pediatric studies in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria. OCT successfully utilizes its network of investigators experienced in pediatric clinical trials representing all pediatric sub-specialties. OCT team has several pediatricians, who can share their experience with clinical team. OCT have a huge database of investigational sites and key opinion leaders in CEE countries where we run pediatric clinical trials. We have experience in evaluation of sites and their appropriateness for pediatric clinical trials. We perform pediatric trainings to the team assigned to the trial. Russia, Ukraine, Belarus, Latvia, Lithuania, Bulgaria are one of the top enrolling countries into pediatric trials. We have performed trials in various pediatric indications:
This is our second trial with the client. We plan to meet client requirements in this study and enroll all patients within 2012.
Conducting research with children is inherently more difficult than with adults. Pediatric patients also offer drug companies a much smaller market and potential economic return. Clinicians often treat children with drugs that have been approved for use with adults but have not been studied with children, even though the drugs may have different risk-benefit profiles for pediatric patients. Recognizing a shortage in knowledge of how medications affect children, a lot of initiatives were created to force pharmaceutical companies perform clinical trials in children.