The new drug had been assumed to have at least the same efficacy as the existing drug for patients with sore throat due to upper respiratory tract infection. Therefore, this trial had a confirmatory objective. The secondary objective of this study was to evaluate the safety of a single dose of the investigational drug compared to the same dose of the drug in existing form.
The total sample size of 440 randomized patients was required for the study. It was expected that it would take 18 months (two cold seasons) to recruit the required number of patients. OCT managed to finish the enrollment within less than 12 months. Moreover, almost 400 patients were recruited by the end of the first cold season (from December 2014 to February 2015). Usually, such a rapid enrollment rate are associated with quality-related risks and delays in data collection. With its pre-developed strategy allowing for quality control of investigators’ activities and adequate data recording schedule, OCT eliminated these risks completely. A total of 15 investigational sites were initiated for the trial with approximately 27 patients enrolled per site. Drop-out rate was about 3%.
OCT has very good experience in respiratory infection clinical trials of various phases. Due to this fact, OCT team managed to achieve a 30% reduction in enrollment duration and improved the overall efficiency of the trial. It was a full-service project for OCT which was responsible for every activity, from the preparation of medical documents, selection of investigational sites and project management to data management and preparation of a final report.