Schizophrenia

Background: Smooth Drug Development was involved in the organization of an international Phase III clinical trial of a drug used in stable state schizophrenia.

About a trial: An international clinical trial was organized by a Chinese sponsor. Our company was responsible for the study in the EU region, including clinical trial approval, site selection, import and export of study drug and biological samples, and clinical monitoring. The study involved 80 subjects at 16 sites enrolled over a period of 5 months.

Challenges: Conducting a study in such a complex nosology requires special attention to site selection. We included 16 centers with expertise in psychiatric trials in the region. The main difficulty with this study was the use of a paper-based CRF, which prevented rapid resolution of data cleaning requests and rapid database closure, so at the end of the study we assigned a large number of experienced monitors to the project to quickly resolve recent requests from the client's data management department. In addition, the project used a large number of scales and questionnaires, which placed a heavy burden on the sites, so we assigned additional coordinators to review the data at the sites. Pharmacokinetic analyses were performed in a central laboratory in Germany, and we obtained permission to export biological samples and controlled all logistics.

The results of this study have been accepted by the FDA and EMA. The drug has already been registered and launched in the US and European markets.