Throughout the Covid-19 pandemic, decentralised clinical trials have become ever more prevalent in the clinical research field, and their uptake has surged.
In a November survey of clinical trial professionals conducted by Oracle Health Sciences, 76% of respondents said the pandemic has accelerated adoption of decentralised trial models, while 38% reported that more than half of their trials had already been decentralised. Amid Covid-19 and the resulting lockdown restrictions, removing the need for trial participants to attend central trial sites has been an important means of keeping trial programmes afloat, and the digital technologies that make this possible have applications far beyond the pandemic.
Ahead of the Outsourcing Clinical Trials West Coast virtual conference, Clinical Trials Arena spoke to IQVIA senior vice president and chief digital officer Nagaraja ‘Sri’ Srivatsan about decentralised trials’ role in the quick development of vaccines and how they are transforming how trials engage with patients.
Kezia Parkins: What have been the main lessons learned from dealing with the Covid-19 pandemic when it comes to clinical trials?
Nagaraja Srivatsan: The Covid vaccine trials fell into three components — patient recruitment, patient engagement and packaging data for regulatory submissions.
We learned that patient recruitment is both an art and a science. We had a lot of great volunteers, but we had to ensure that the population set that we recruited was diverse to ensure that the vaccine works for everyone. Additionally, we had to ensure that we recruited the right patients with the right profile to the right site. We harnessed a lot of technology, data, insights and analytics to figure this out.
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On the patient engagement side, we learned a lot of best practices. First was the use of digital technology to conduct trials at such a huge scale. Many of these trials needed over 40-45,000 patients to be recruited and managed so the use of digital technology was imperative to support the scale, speed and velocity of the trials.
Using technology while working with a diverse population set, we found that you need to give a high human touch. Nowadays, everybody has iPhones but with technology, you can’t expect things to always run smoothly and some patients may need assistance to use the tools. Therefore you need a call centre to help. We also have what we call a study concierge on sites so that they can help sites with patient management. I call this digital plus human working in unison.
Once you have accumulated all the different data that is when data surveillance comes in. This looks at everything from how often a patient filled out a diary, to which sites are compliant with study protocol. It’s looking at those endpoints needed for the study and ensure that they are collected. When there are gaps in the data, technology and human follow-ups are leveraged to help fill in the gaps in the data.
The Covid-19 trials taught us that you need to have the digital technology first otherwise you can’t scale and engage a huge patient set over several countries. But technology alone is not enough – you need the right processes and personnel to support the sites.
KP: What digital technologies have helped to advance decentralised clinical trials?
NS: With Covid and other disease areas, we relied on this new model we call decentralised or hybrid trials, which means that the protocol can have some visits at the site and some visits at home or remotely.
For recruitment, we use artificial intelligence and machine learning because we are looking to recruit a diverse patient population and we need to target them efficiently.
Once we have matched a patient for a trial, we need to get their permission or consent. We now use digital technology like e-consent to get patients to digitally review and consent to participate in the trial.
We then need to engage the patient and provide them with the digital tools and mechanisms for them to participate. In addition to telepresence where we use digital mechanisms to virtually connect with the patient, we use other mechanisms like — notifications, email, and digital applications to gather data from patients such as diaries. Diaries are very important components because they tell us what patients are doing and feeling and this enables us to collect endpoint data and monitor patient progression in the trials.
Finally, we use connected devices or wearables to test for things like antibodies and patient oxygenation level. These can be set up in a patient’s home where they can take the measurement. That data then goes to the cloud and back to us.
Now that we have all of that valuable data from test samples, diary data, and patient engagement we need to know who is and isn’t engaged or which patients are missing doses for example. So we go back to an infrastructure of big data, analytics and AI. Once we have these insights we can then intervene where needed and that’s the full loop – collect, analyse and intervene.
KP: What are the main considerations for scaling up decentralised clinical trials from early clinical studies to larger, more complex late-phase trials?
NS: This model can work across all trial phases to scale. There is no barrier to starting small and then ramping up.
Previously, life sciences companies – who are quite risk-averse – had been hesitant with concerns about data and virtual and decentralized models. After Covid I don’t think that concern is as high, everybody now understands you’re capturing good quality data when you engage the patients proactively which can ensure that we get high-quality data that can be used for submission to regulators.
Sponsors and even regulators are now looking at this and saying, this is the new normal, and that we shouldn’t go back to the previous way.
KP: What are the challenges of hybrid trials and integrating clinical data from multiple sources, both digital and physical sites?
NS: A big challenge is working to reduce the burden for both the patient and the site — two stakeholders that are very burdened in a hybrid model as data is interspersed between the two.
For patients, reducing the burden is easier because they have an app or portal to use as an engagement platform. Whatever they enter is visible to everybody. It doesn’t matter if they’re at the site or at home. Everything is in one place to communicate their data and needs.
Reducing site burden is more difficult because they need to integrate data from the patient as well as the data collected on-site. That’s why the integration and interoperability of the technologies are very critical.
Sites are also burdened by setting things up and following up with patients. If there are 60 people who did not fill out their diary, the sites who uphold the patient relationship will need to call and check-in. But without data and data surveillance, they’re flying blind. So this is why the data surveillance is very critical.
KP: After a year of Covid-19 and carrying out trials under these conditions, do you think that the clinical setting will come out the other side with more efficient and flexible processes for the future?
NS: The uptake of decentralized clinical trials has definitely been accelerated by Covid but I firmly believe that now they are becoming the new normal and have made us challenge our risk profiles and made us more efficient.
We’ve learned a lot and can now see that decentralised trials are the way to go because you can get better engagement, more and better data and increased patient satisfaction. I think this is the way of the future and that it will make the processes more efficient. All the regulatory authorities and industry groups, whether it’s FDA [US Food and Drug Administration] or EMA [European Medicines Agency], are looking at this area and talking about how this could become mainstream.