Indication Determination and Patients Stratification

  • Stage of Clinical trials determines the “Go” or “NO Go” decision for an investigating new drug during the whole process of new drug R&D projects. In this stage, which indication(s) is (are) the best choice, and what kind of bio-marker(s) is (are) suitable for guiding patients inclusion or exclusion, are two crucial questions to be figured out.


Stage of Clinical trials

 

  • Traditional way is to launch a basket trial to enroll all potential patients with selected indication(s) to see which is/are the best for further phases of trial, while in selected population(s), using umbrella trial to determine possible bio-marker(s) for patient stratification. However, these actions will be costly in clinical stage, and would mess up the ongoing project if it failed to be done. Therefore, LIDE has developed a platform that enables the basket + umbrella trial to be performed in pre-clinical stage to identify such indication(s) and/or patient stratification(s).
    The basket + umbrella trial