The following success stories demonstrate how IDDI innovative Biostatistics and eClinical solutions are key in the successful conduct and outcome of your clinical trials.
Anti-cancer drug approved based on a surrogate endpoint
Surrogate endpoint for overall survival
We managed to prove, using data from a randomized trial comparing Ceplene + IL-2 to no maintenance treatment, that leukemia free survival was a good surrogate endpoint for overall survival in patients in complete remission (Haematologica 2011). We also showed through meta-analysis that IL-2 alone was not better than no maintenance treatment in this patient population (Blood 2011). These facts resulted in the approval of Ceplene (from Epicept, then taken over by MEDA).
Using Minimization for a Complex Trial Design
A multi-center phase II trial was conducted in just over 100 patients to compare metabolic changes in the prostate after administration of two treatments for locally advanced prostate cancer. The changes of interest were assessed by a biopsy taken at different randomized times and by magnetic resonance spectroscopy/magnetic resonance imaging (MRS/MRI) in about one third of randomly selected patients. In order to protect against chance imbalances, patients were additionally stratified by their level of prostate-specific antigen (PSA) at baseline. The methodology adopted to implement this complex trial design was minimization for the various randomized factors.