Patients, as well as physicians, are increasingly looking to enrol into clinical trials that use a precision medicine approach, one in which biomarkers (tumour profiling), not simply diagnoses guide enrolment. Such trials offer the promise of faster drug development as well as an individualized treatment. In addition to enrolment criteria, precision medicine trials differ from CT in their design, which includes far fewer subjects, and may not include a placebo or standard care comparison group. The following concepts will be discussed using specific trials examples. Adaptive trial designs, precision parameters, biomarkers and trial management.
Chairperson: Paul Cohen, Director Scientific Affairs, Biointelect