Webinar on Biostatistics: E9(R1) Addendum…
[Industry Voice #11] Stayble Therapeutics…
OCT Clinical, an Eastern European contract research organization, has successfully completed the recruitment of 612 patients in a neurology study for a leading Indian pharmaceutical manufacturer. This is a multicenter, prospective, double-blind, randomized, parallel-group comparative study. The aim of the project is to determine the efficacy and safety of the drugs Ibuprofen + Chlorzoxazone (Dr Reddy's Laboratories Ltd., India) against a comparator in patients with acute nonspecific lower back pain.
Despite pandemic-driven uncertainty, the enrollment target was reached within an impressive seven months. With recruitment starting in June 2020, the last patient was successfully randomized in February 2021. The tested drugs have been studied at 28 research sites across several cities in Russia. The clinical study participants are men and women aged 18-55. With 612 study participants randomized out of 646 screened, the OCT Clinical team demonstrated an impressively low screen failure rate.
“Due to the Covid-19 situation, we have encountered some challenges, such as a number of research sites entering lockdown, which made us start looking for immediate replacements. But effective and thorough project management allowed us to recruit all patients in time and establish monitoring visits even during these uncertain times,” — Julia Stepanchuk, Project Manager at OCT Clinical.
“We are pleased with OCT Clinical’s ability to maintain motivation among their employees and meet our recruitment goals within agreed timelines, especially during these tough pandemic months,” — said Alexander Khaymenov, MD, Ph.D., Head of Clinical Research at Dr. Reddy’s Laboratories’ representative office in Russia.
In this project, OCT Clinical is responsible for a wide range of activities, including medical writing, project management, site selection, medical monitoring, data management and statistics, material logistics, and pharmacovigilance.