Insights on Decentralized Trial Execution

Nearly two-thirds of healthcare experts plan to leverage decentralized clinical trials soon, according to a June 2020 GlobalData survey. COVID-19 has accelerated adoption, but sponsors say the decentralized model will transform how trials are executed for years to come. Dr. Michelle Longmire, Chief Executive Officer and founder of Medable, sits down with Moe Alsumidaie to discuss what it means for the future of life sciences.

Moe Alsumidaie: Canyou please provide an overview of the current decentralized clinical trial (DCT) landscape? What percentage of companies have already or you expect will fully embrace DCTs versus just piloting?

Dr. Michelle Longmire: Many life sciences companies, CROs, and sites are embracing

Dr. Michelle Longmire

decentralization of trials right now, mainly out of necessity to give access to patients in their homes as sites are closed from the pandemic. Even for open sites, organizations want to reduce exposure and ensure everyone has an opportunity to participate in research remotely. So there has been significant adoption of DCTs in our customer base. We grew revenues by more than 400%, year over year, including the addition of nine large pharma customers in the first half of 2020.The trend spans across sponsors and therapeutic areas as well as investigator-led studies.

The decentralized model works for the full gamut of the clinical life cycle – not just the core, evidence-generation phase. It starts with patient recruitment, screening, and consent before progressing to the full enrollment process, and then evidence-generation. Decentralization supports that entire process and whole patient journey. We prioritize the patient’s journey as we develop new technologies, as we think through what needs to be considered from an IRB perspective, and as we consider trials on a global scale while ensuring they are still applicable to individual countries, communities, and individuals.

MA: How has COVID-19 impacted DCTs? What does the landscape look like before and after COVID?

Dr. Longmire: Absolutely, there has been a massive adoption of DCTs since COVID hit – at least three times the volume that we saw before COVID. At Medable, we have partnered with the leader in virtual recruitment and screening to enable that process to be entirely virtual. We already see remarkable improvements in efficiency, even compared to pre-COVID screening practices in person. Sponsors are increasingly adopting decentralized methodologies very quickly. Plus, individual sites are growing more comfortable with incorporating telemedicine and remote consent procedures.

MA: What do you think is needed to help ensure that a DCT is successful?

Dr. Longmire:One of the most important things is to initially focus on areas where you have a high degree of feasibility, and where you’re looking at it from a risk-based perspective from the beginning. Trials are never risk-free, but certain things are going to be more valuable and less risky. For example, virtual screening increases patient access and reduces the risk of COVID contagion.

Consent is another ideal opportunity for decentralization, which also improves the patient experience. There’s a lot that can be managed remotely, and some actions that are better handled in person – like an invasive procedure. There is a push for some of those activities to be conducted in the home, but as a physician myself, I still see great benefit to having the full suite of access that a hospital affords.

It really comes down to scope. Start by doing a feasibility analysis focused on the benefit to risk, and then sponsors can narrow the application of DCT to the set of actions or processes that add value without adding risk. There are many things that DCTs will work for in nearly any indication across a trial’s lifecycle, from screening and enrollment to data collection.

MA: What results do you see in DCT implementation?

Dr. Longmire: DCTs can tackle four core challenges that clinical trials historically face.

The first is patient access. Virtual screening and remote eConsent can dramatically improve access to clinical trials. We’re seeing that these decentralized processes consistently enhance patient recruitment, and we’re developing a baseline dataset for comparison.

The second challenge DCTs help overcome is patient retention. Compared to traditional methods, we see significant improvements when we’re able to reduce site visits that are more focused on basics such as screening, enrollment, consent, and non-invasive evidence and data capture.

DCTs also help overcome issues with data quality, as you mentioned. At a minimum, we want to be meeting the standard for data quality. And in many settings and across various therapeutic areas, we can do that remotely. At Medable, we are starting to think about digital endpoints as a complement to traditional scales and measures. DCTs help with the development of new digital endpoints that are of the same, or better, quality than conventional endpoints. Digital endpoints also provide the opportunity to dial into more disease-based measures for diagnosis and severity.

The fourth main challenge DCTs tackle is efficiency. Traditional clinical trials take much time and come with very discrete processes, as different teams generally do recruitment and consent and evidence generation with diverse strategies and varying technologies. In contrast, we provide a process solution versus a point solution with one interface that drives streamlined workflows and provides seamless decentralized capabilities. This improves overall trial execution efficiency.

MA: How do you see clinical trials evolving in the future?

Dr. Longmire: We take the perspective of centering the process around the patient, so that’s where our view on processes like screening, recruitment, enrollment, and consent lean towards a decentralized approach since it is more comfortable, more convenient, and less costly for the patient. This is true for any therapeutic area.

The evidence-generation phase will break down according to two main parameters. One is the therapeutic area, and the other is the objective of the visit. So there will be some visits, regardless of the therapeutic area, that are fit to go virtual and others, where a physical assessment in-person is vital that won’t.

How a drug is administered may be a factor, too. Topical and oral administered medications can be done at home, but site visits or in-home nursing visits may still be required where a drug is administered intravenously. We will get to a place with disease-specific endpoints that are also aligned with patient outcomes, and that will be an opportunity for new digital measures, but there will continue to be some measures that are just best measured at a site.

I don’t see this as a failure because our objective isn’t to decentralize trials. We aim to make trials more effective, more efficient and ultimately get effective therapies to patients faster. DCTs are one approach, but disruptive technologies will emerge that will build upon the DCT model.

We must tackle clinical trial challenges by looking at how technology can facilitate access and increase retention, data, quality, and efficiency—and not stay married to one specific methodology.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.