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30 Jun 2021 | 02:30 PM GMT

Clinical Validation standards for DTx: current vs. desired

Anchored by:

Miron Derchansky
Managing Director
BLACKLETTER GROUP
Koen Kas
Founder and CEO
HEALTHSKOUTS

Participants:

Koen Kas Founder and CEOHealthskouts
Koen Kas
Founder and CEOHealthskouts
Miron Derchansky Managing DirectorBlackletter Group
Miron Derchansky
Managing DirectorBlackletter Group
Dr. Nick (Nemanja) Kovacev Head of Healthcare and Life Sciences PracticeHTEC Group
Dr. Nick (Nemanja) Kovacev
Head of Healthcare and Life Sciences PracticeHTEC Group
Garret Coady CEOBlueBridge Technologies
Garret Coady
CEOBlueBridge Technologies
George Platings Director of Business DevelopmentuMotif
George Platings
Director of Business DevelopmentuMotif
JM
john mattison CMIOACP
JM
john mattison
CMIOACP
Jordan Silberman Dir of Clinical Analytics & ResearchElevance Health
Jordan Silberman
Dir of Clinical Analytics & ResearchElevance Health
Lorenna Feliz Santos CEODiaM Life Inc
Lorenna Feliz Santos
CEODiaM Life Inc
SG
Stephen Gilbert Clinical Evaluation DirectorAda Health
SG
Stephen Gilbert
Clinical Evaluation DirectorAda Health
TP
Thomas Paisant Head of Medical PartnershipsGuty
TP
Thomas Paisant
Head of Medical PartnershipsGuty

About this Meeting

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:

  • Current validation standards: useful frameworks and best practices guides (e.g Nice framework in the UK), role of RCTs vs. other studies (e.g observational, RWE, etc), and how validation requirements change depending on the product (e.g low-risk DTx, therapeutic areas with few available solutions, etc).  
  •  Desired validation standards: regulatory and reimbursement frameworks will evolve to adapt to new technologies;  what does the future of DTx validation standards look like? Role of alternative methods like RWE, observational studies, peer-to-peer revision, etc.