FOR PCT TV (at Partnerships in Clinical Trials Europe in Nov 18), we spoke to Dr. Raphaela Schnurbus, Clinical Solutions & Business Development Director at CRO OPIS, to discuss how Virtual Trials and Real World Evidence could change the clinical trials of the future, and how the CRO landscape is evolving.
Are Virtual Trials a realistic approach for the future? What challenges still need to be overcome?
'Virtual trials are a huge challenge and have created a lot of interest recent, and they are an appealing solution to many aspects [of clinical trials].
Virtual trials mean that not only do we have a significant reduction to operational costs, overhead costs and travel costs, but we should ask ourselves the question what does it mean for the patient? The patient is at the center of our clinical trials and the patient needs to be safeguarded. In this case we know statistically that there is a higher retention and better compliance with patients because caregivers can go to the patient's home and provide drug supply, do sampling and collect initial data.
However, we need to take into account the risk for the patient too. As far as the data from the patient is concerned, we do not have on-site verification depending on the therapeutic indication of the disease so we need to see the whole context.So in certain disease areas it is not recommended.
The future will be significantly changed by virtual trials, but they are not replacing on-site managed trials, so I think there will be a mixed model.'
How important do you think Real World Evidence and within that, data integrity is?
'Real World Evidence is very trendy and I think I'll be quite reluctant in my answer because we really need to understand what it means. What is RWE? What does it meant to have real world data collection? RWE is traditionally happening more in late stage trials and the tendency is to bring it also to early phase development.
This means more and more digital trials, and data collection through mobile devices, ePROs and social networks; there are many innovative and new technology based models to collect all the data. This means we have more and more data and the challenge is what can we do with all this data. We need to learn to have a very scientific approach and methodology in the data analysis. We need the specialized resources; data manager and data scientists who can manage the collection and analysis of this huge amount of data.
It's also important to mention that there are differences in geographic areas; between the US and Europe. The data standardization and integration in the US are more advanced probably due to the fact that in Europe we have a lot of national regulations and national health systems and it is more difficult to bring the health leaders together for integration, standardization and harmonization of their approach.'
With such innovations coming in to clinical trials, how do you see the CRO landscape changing more generally?
'Due to the fact that all the assets within clinical trials are changing, so CROs are becoming more and more involved in the trials and we have an increasing tendency for pharma and drug developers outsourcing their trials. They're fully outsourcing their trials and not just going to one provider, but asking a bunch of providers to give them everything.
So you now have specialized companies and then the big companies getting bigger with huge acquisition processes ongoing; so probably at the end we will have fewer big players providing broader services. This means that the smaller providers and mid-size companies need to specialize or be able to compliment their service offerings through integration of other vendors. CROs are specializing in therapeutic areas - in dermatology, in paediatrics - or they combine.
A another new aspect that is needed - and CROs are already going in this direction - is to understand the whole drug development process. So we don't just say 'we will bring your drug through each phase, but we see the whole picture, the whole drug development environment and are able to integrate where services are needed. A really highly scientific approach is needed.'