Measuring Efficacy and Safety of DTx

There are a broad number of DTx solutions, but in order to thrive and be successfully adopted, prescribed and reimbursed, it is essential to prove their efficacy and safety. How can we measure DTx efficacy and safety so that they are validated with uniform rigor across settings? Considering the challenges DTx companies are facing when it comes to performing RCTs (cost, time and constantly evolving softwares/devices), is RWE the best choice or is it a variation of gold standard RCTs? Although regulatory frameworks are going to evolve to adapt to new technologies, the inherent conservatism of regulatory processes will probably make this a long and tedious journey; what can the industry do to accelerate the changes needed?  Join this meeting to discuss with other thought leaders the best practices to measure efficacy and safety of DTx, how the requirements change depending on the stakeholder and the characteristics of the DTx product, and the role of regulatory bodies in DTx validation.