14.Jan.2013

OCT is awarded with an epidemiology trial in gastroenterology

OCT has been granted an extensive epidemiology study by one of our returning clients. The Sponsor is the Russian office of a large international pharmaceutical company. OCT has previously conducted six clinical trials for this client, and this will be lucky number seven. This study is aimed at estimating the incidence of abdominal pain syndrome in patients visiting gastroenterologists, and discovering which medications are commonly used for treatment of this medical condition in Russia.
OCT has been granted an extensive epidemiology study by one of our returning clients. The Sponsor is the Russian office of a large international pharmaceutical company. OCT has previously conducted six clinical trials for this client, and this will be lucky number seven. This study is aimed at estimating the incidence of abdominal pain syndrome in patients visiting gastroenterologists, and discovering which medications are commonly used for treatment of this medical condition in Russia.

OCT has never conducted such a challenging trial, but we are always ready for new and exciting endeavors which will extend our horizons. The study will cover over a 1000 investigators who will collect data from over 22,000 patients. Such a huge trial will require involvement of a professional clinical team to maintain contact with all the participating investigators and ensure high quality data collection. Communication and site management are the activities of the highest priority in this trial. Any miscommunication with a 1000 investigators might cause significant trial delays. Even signing study contracts with sites prior to the study becomes a challenge when a clinical team needs to contact 1000 investigators from all over Russia within 9 different time zones. Our experienced project manager has planned all the resources needed to be involved as well as all the pass-through costs prior to the budget finalization to make sure no organizational or financial circumstances can affect the trial timelines.

The study timelines is another challenge OCT will have to deal with. More than 22,000 patients will have to be enrolled within one month and data will need to be collected from over 1000 sites within one month. Another two months will be given to OCT to organize site payments and perform data clearance and data analysis. The full spectrum of data management services will be provided by OCT to our client.

This is the fifth clinical trial in gastroenterology OCT have conducted. Another two trials in this therapeutic area have been granted to OCT this month. Among successfully completed trials we have a trial in Crohn’s disease, liver disorder, eradication of H. pylory and a pediatric trial in intestinal colitis. The largest gastroenterology trial we conducted was the liver disorder trial with 600 patients enrolled in 32 sites within a year. As for post-marketing trials, OCT has completed as many as 7 such studies and we are quite sure we will meet the Sponsor’s expectations even in this challenging study.