Fig. 3
Life cycle of the ProBio platform trial. After written informed consent, the biomarker subgroup combination of the patient is determined and used for randomization to either the control group (standard of care) or one of the experimental arms. Outcome data are updated monthly throughout the trial and will be used to calculate the probabilities of superiority for the active arms over the control group for each biomarker signature of interest. Based on the selected threshold, a decision to continue enrollment or to terminate (for futility or superiority) each treatment-biomarker signature will be made. As treatment-biomarker signatures leave the platform, new treatments can possibly entry in the study. The outcome data is also used to update the randomization probabilities within the biomarker subgroup combinations. Graduating treatment-biomarker signatures will enter a confirmatory trial to validate the hypotheses generated from the platform