Clinical Validation standards for DTx: current vs. desired

DTx products need to be clinically validated to get regulatory approval and reimbursement. Randomized Controlled Trial (RCT) is the gold standard when it comes to proving clinical efficacy and safety and currently 48% of PDT companies have already conducted RCTs for one or more of their products. But, even though RCTs seem to be a necessary starting point for innovators, DTx and drugs are different in nature and should probably not be validated by the same traditional standards. Hence, there is still need for improvement in the validation frameworks for DTx solutions. Join this informal conversation where we will discuss: