Digital Decentralized Clinical Trials (DDCT): How will digital solutions change the way clinical trials are conducted in the future?

The Digital Decentralized Clinical Trials solutions arising as a result of the Covid-19 pandemic have attracted more and more investment from companies. Because of this, the entire clinical trial landscape is changing, revolutionizing the world in which they are conducted.

A recent round table held to inspect and discuss the current state and trends of the DDCT market in the US and EU included moderator Ralf Jahns, Managing Director at Research2Guidance; Isabel Cassidy-Soto, Consultant at Research2Guidance, Stefka Lysk, Head of Clinical Development at Newsenselab Operations, Paul O’Donohoe, Senior Director, eCOA Product and Science, Medidata , Katri Langel, Senior Program Development Europe at Curebase, and Karl-Ludwig Radek, Associate Director, EMEA Strategic Account Lead at Janssen Pharmaceutical.

Isabel began by highlighting the main problems with traditional clinical trials, namely that 80% are stopped due to recruitment issues, 70% of patients live at least two hours away from the trial site, and 30% of patients drop out, with $6,533 being the average cost of replacing them.

Obviously with DDCTs, all of this would change, leading to an exponential improvement in patient management, and thus, the whole clinical trial system. The study shows that in North America and the European Union, there will be an exponential increase in the use of virtual technology between 2020 and 2026 as it takes over every step and process of the clinical trial.

The use of virtual trials will bring six main benefits, such as faster patient recruitment thanks to big data, better quality of data collected, better patient retention, improved patient adherence rates, increased patient diversity, and reduction of time and costs.

Katri then demonstrated the overall 17-year Decentralized Trial history and how the differences between the US and EU markets allow, or rather, limit, the different stages, perspectives, and capabilities in the evolution and digitisation of clinical trials. However, there will also be limits to what can be expected from this transformation, what the roles of pharmaceutical companies will be in the evolving market, and above all, what parts of clinical trials can be conducted virtually. The panel confidently foresaw the real-world settings, digital endpoints, and new models for sites, BYOP, and community providers.

Next, Paul addressed the topic of Big Data in relation to media and how it may impact the current and future landscape from the viewpoint of Medidata, which provides a platform for the entire lifecycle of clinical trials from start to finish. He also showed the panel how the number of countries involved in phase III research has doubled, with a 60% increase in the number of research sites involved, and 86% more data collected to support the end points, yet simultaneously, 23% of patients dissatisfied with the site location, resulting in 30% of them abandoning the trial before the end of the study. Of course, this was before Covid-19.

In addition, the period from March 2019 to March 2020 generated a 65% drop in patient engagement. Consequently, Medidata’s aim is to maintain some level of engagement continuity and data capture from patients. For this reason, their goal is to have more heterogeneous vs. “typical” patients, literally changing the patient journey while obtaining more qualitative information.

What enabled the evolution of DDCT was a combination of:

– Increasing complexity of trials

– Forced functionality of the pandemic

– Empowered and informed patients

– Availability of technology

Nevertheless, this does not mean that the goal has been reached. On the contrary…we are only at the beginning and must remember that the right approach will always vary according to the specifics of each firm. More collaboration between technology providers and the pharmaceutical sector will be needed, starting with internal education and awareness that can subsequently be taken outside. There is still a long way to go.

Karl proceeded to explain how these elements are being discussed and how sponsors are all making the same demands, resulting in the need to rethink how clinical trials are designed, how they are carried out, and how stakeholders can join forces to achieve the same goal.

Finally, Stefka Lysk presented a key study on the development and process of providing an easy-to-use application for migraine sufferers, the results of which are not yet available. For now, there are a lot of incredible prospects for the future, particularly in Germany, which offers different opportunities.

What will happen post-pandemic cannot be said yet, but it has certainly already led to an acceleration of the trends seen in previous decades, albeit much more slowly. It will certainly lead to a greater awareness of data usage in a more qualitative way and hopefully also to a streamlining of the regulatory processes that limit and differentiate markets. Companies will also play an increasingly important role as sponsors, as they can become service providers for apps and web-based solutions.

Author: Alessia De Metrio, Account Assistant at Healthware International

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