Bardot: We have heard from sponsors that we have approved statistical analysis plans that include virtual patients. [On April 17] we have an MDICx webinar on the virtual patient, which includes two FDA speakers.

But what’s really great is we’ll be able to hear FDA’s interest in Bayesian [statistical] methods, we’ll be able to hear industry examples of retrospective analyses that worked for them, and we even have one of our speakers talking about how you brief an FDA-advisory panel if you’re going to use virtual patients.

Murray: We have now eight retrospective analyses that have been done where sponsors went back and looked at prior clinical trials and said 'If we were to incorporate this statistical model into our trial design, what would be the impact?' And now what we have is two statistical analysis plans … that have been submitted to FDA where FDA has accepted that plan as part of the clinical study, which means the opportunity is for a clinical trial to have fewer actual patients enrolled, but still all the power and the significance associated with a traditional trial.

And I think that is the opportunity, and that’s the value proposition that MDIC brings when we talk about the cost of innovation, gaining access to patients that are safe and effective, maintaining the rigor and confidence in the performance of the product but making it more effective and efficient.

Bardot: What MDIC has done – and the value proposition that MDIC provides to the ecosystem – is that we can help with the development of these methods, and we can help with how you operationalize and de-risk these methods. So by creating the mock submission, then by creating the retrospectives, we’re showing that there’s the proof in the pudding. We’re showing how the rubber hits the road so that when sponsors pick them up and use them prospectively, they can have higher confidence in how you use it and how it will be viewed.

And then what we, as an organization, want is for those sponsors to come back and tell us about their experiences, because that’s how we’ll be able to both improve the method and learn how the method’s actually working in practice. And that means that those sponsors have to share that with us.

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