Real World Evidence in Clinical Trials

Even when we look at some of our smaller biotech clients, it's helping them see what the future looks like through developing an integrated evidence plan so that they can almost have a blueprint for where they're going and how to think about their product development.

My name is Matthew Gordon. My role at Parexel is the vice president of real world evidence strategy.

When you look at how medicines and treatments are approved throughout the world, we look at how it's actually being used. So clinical trials test medicines to see if it's safe and effective. We look to see is it really useful, is it really safe? Is there value to what you're using, how you're treating patients?

Depending on how you're actually leveraging or using real world evidence, it will have a direct impact to the operational strategy, how you would use it, how it might be accepted by regulatory agencies or different stakeholders, whether that's payers, healthcare providers, you name it. Those that are stakeholders within the field leveraging real world evidence, you have to make sure that it's very fit for purpose.

Evidence generation is not like you're really generating data. You're taking data that's already in the marketplace. So, you're looking at how patients have already been treated. You're using that to understand how physicians have been treating these patients. So early on in the development as you're thinking about a new product and you're thinking about a protocol and who's the potential patient population that's going to be, you know, most at benefit for this. Real world evidence helps you target that more effectively.

Real world evidence really is front and foremost for the patient and what we're what we're saying, we're reporting on, is really based on how that patient has lived and how that patient has been treated.

Real world evidence allows us to see what is the impact of those decisions, what are some of the socio-economic impacts on patients in a in a real setting so that we can actually try and treat patients more effectively.