Bioequivalence study in oncology patients

Background: Our company organized a bioequivalence study of an anticancer drug in oncology patients.

About a trial: Smooth Drug Development was responsible for CRF development and data management, involvement of a bioanalytical laboratory, selection and monitoring of sites with experience in oncology and the necessary equipment, pharmacovigilance and medical monitoring, development of the final report.

Challenges: For the study, we opened 8 sites in the region, which recruited 48 subjects in 4 months. The sites were experienced in oncology research and approved for bioequivalence studies. For this study, we needed to select sites with the ability to admit patients, experience in collecting and processing pharmokinetic samples, and equipment for freezing blood. To meet the protocol requirement that all subjects receive the same diet, we provided prepared meals with the same calories intake at all sites. In addition, to motivate patients to participate in this study, we offered to provide the client with a drug to treat patients, which facilitated patient recruitment