Antitumor drug for blood cancer

Background: Smooth Drug Development was involved in a bioequivalence study organisation on patients of an antitumor drug for the treatment of myelodysplastic syndrome.

About the trial: During the project, our company was responsible for medical writing, registration strategy development, biostatistics, data management, project management and logistics. We also provided central monitoring, medical monitoring and pharmacovigilance services during the trial.

Challenges: Myelodysplastic syndrome can be categorized as an orphan disease, so we paid special attention to patients recruitment. In order for the project to be feasible, our scientifical department discussed in detail the criteria for inclusion and non-inclusion of patients. During patient recruitment, we actively engaged referral sites and patient communities. In addition, to keep patients interested in participating in this project, the Sponsor, on our recommendation, also provided the original drug for the subjects to be treated after participating in the study. This helped us finalize enrollment of 40 subjects in 6 months.