TRIAL DESIGN AND EVIDENCE: PANEL INTERVIEW

Expert panel interview with:

Nicola Wall, PhD

CEO at Afortiori Development

https://www.linkedin.com/in/nicola-wall-phd-42ab3814/

Greer Deal

Director at Global Regulatory Services and Med-Di-Dia Limited

https://www.linkedin.com/in/greerdeal/

Questions:

- What are some of the unique challenges re: clinical trial regulations that digital health companies face?

- When are RCTs appropriate for trials of digital health products/services and how do you calculate the minimum number of subjects? – what are the alternatives to RCTs for DH products/services?

- One of the strengths/weaknesses of digital health is patient engagement. How can you design a trial to demonstrate safety and efficacy when engagement is such a nebulous but important factor?

- When considering the duration for effective trial design what factors might impacts this for digital health products and services?

- If you are engaged in something truly novel that that regulators may not be familiar with, what advice would you share?

- Let’s think about evidence generated in various geographical locations or countries - How can an organisation effectively manage this and provide results which are accepted and compliant in various other markets? How does digital health influence this?

- What are the key ingredients and challenges for successful evidence generation from remote trials and in fact for all types of trials?