30 Sep 2021 | 01:45 PM GMT
Past Meeting

Measuring Efficacy and Safety of DTx

About this Meeting

While there is debate around whether DTx should be held to a higher or lower standard than traditional drugs, it is clear that in order for these solutions to be successfully adopted, prescribed and reimbursed, they have to meet the evidence requirements of the different stakeholders, regardless of what these demands are.  How can we measure DTx efficacy and safety so that they are validated with uniform rigor across settings? 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 with other senior leaders to discuss: 

  •  Best practices to measure efficacy and safety of DTx: RCTs design (sham DTx, comparators, participants diversity, etc) and the role of Real-World Evidence (RWE). 
  •  Strategic partnerships to generate DTx evidence. 
  •  How do the requirements change depending on the stakeholder and the characteristics of the DTx product? 
  •  What is the role of regulatory bodies in DTx validation?

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