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Talking simulated clinical trials with Ramon Hernandez, Sanofi

Ramon is head of RWE data and analytics. He works to turn the output of analytics models into business actions and ensure the best practice sharing of innovative techniques and projects.

At Sanofi how do you use Real World Data to complement evidence coming from clinical trials?

We are using RWD to inform randomised clinical trial (RCT) decisions related to patient subgroups and outcomes selection. Patient subpopulations gives us a deeper understanding of the sub-goups of a disease state and therefore, a population sample where you can better predict the evolution of the disease and treatment outcome.

Now in drug development, we are seeing RWD being used to replicate traditional patient randomisation in RCTs. In addition to reducing the number of patients required for clinical trials, the use of synthetic arms should make recruitment easier as patients have no fear of being placed on the placebo.

What are the limitations of using simulated clinical trials?

Principally, if you are using RWD for submission i.e. as a synthetic control arm, the access to data and the quality of the data will be a major roadblock. Whereas, if you’re using that data only to inform, or enhance, clinical trials you are not subject to those additional regulatory concerns.

In terms of innovation for collecting RWD do you see anything on the horizon that might supersede the current technologies such as wearables and apps?

These technologies have quickly become invaluable in informing trial design in the short and longer-term. I can only predict that we will have even more in the future to collect data in a continuous way and dramatically influence future clinical development.

How do you ensure true implementation of RWD at Sanofi?

We believe that using RWD to better understand patients subpopulations can produce efficiencies  in RCT development. This is expected with patients having a greater efficacy to the therapy and so endpoints can be achieved earlier but it needs to be proven in practice.

But to truly extract maximum value we must work with every single team and product, ensuring that they genuinely appreciate RWD as a source of evidence. But they, at the very least, must consider RWD as a source of evidence at every stage so that it is embedded into the clinical development plan.

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