Frontiers Health roundup panel discussion with key thought leaders on: How will digital solutions change the way clinical trials will be conducted in the future?

Digital decentralized clinical trial (DDCTs) solutions have become increasingly attractive and the investment into DDCT companies has tripled since the beginning of the pandemic. It is expected that from 2020 to 2026, the share of the total clinical trial market captured by DDCT providers in North America and Europe will increase from 2.8% to 21.3%.

At this years’ Frontiers Health event in Milan, Research2Guidance’s team together with key decision-makers from two innovative DCT companies, a novel DTx solution provider, and a leading Pharma company delved into digital decentralized market landscape and six main business models, the types of digital solutions and in what ways digital tools change how clinical trials are conducted, market trends & how can trial sponsors benefit from DDCTs solutions.

On November 12, 2021, Research2Guidance hosted a virtual Digital Decentralized Clinical Trials panel session at Frontiers Health with global top market players as guests that exchanged views and opinions on how will digital tools change the way clinical trials will be conducted in the future and explored the current status and trends of the DDCT market in North America and Europe.

The workshop-like discussion was stimulated by a short introduction from Ralf Jahns, MD of Research2Guidance and the session moderator, followed by key digital decentralized clinical trials market and main business models insights, as well as the ways innovative tools are used throughout the research process, all data-driven metrics and analyses from R2G’s latest report on “The Digital Decentralized Clinical Trial (DDCTs) Solutions Market 2018 – 2026” presented by Isabel Cassidy-Soto, Digital Health Consultant, Research2Guidance.

Cases and highly insightful market points were shared by

• Paul O’Donohoe, Senior Director, eCOA Product and Science, Medidata
• Katri Langel, Sr. Program Development, Europe, Curebase
• Stefka Lysk, Head of Clinical Development and Operations, M-sense Migräne by Newsenselab
• Karl-Ludwig Radek, Ass. Director, EMEA Strategic Account Lead, Janssen Pharmaceutical

that demonstrated unique business models and service offerings, as well as a sponsor trial view about DCT’s role, benefits and cons of DCT value proposition. The dynamic market picture was completed by an engaging discussion.

The digital decentralized clinical trials market is very interesting and dynamic. Decentralized trial designs leverage innovative tools, such as telehealth, mobile applications to allow for remote data collection and patient participation, in contrast to traditional trial designs involving a physical site for all activities.

Digital decentralized clinical trials solutions and services have experienced a boom due to the COVID-19 pandemic. DCT has made sponsors and market players rethink how clinical trials are designed and how they are executed. To be successful there is a need for collaboration between providers and pharma, as well as sponsors (different Pharma companies) to join their forces.

The market for decentralised clinical trials will grow by almost $8 billion (38.5% CAGR) from 2021 to 2026. The revenue from the DDCT market will reach $9.13 billion by 2026.

In her presentation, Isabel (Research2Guidance) touched upon several key points that set the scene for an inspiring conversation.

TRADITIONAL TRIALS PROBLEMS. RISE OF DECENTRALIZED CLINICAL TRIALS.

Some of the problems that R2G’s team have seen during the extensive DDCT market study were:

Recruitment – 80% of the clinical trials were either delayed or stopped because there was a challenge faced with the recruitment, such as, for example, not enough patients could be immediately recruited.

Retention – In the US 70% of patients live more than 2 hours away from the trial site. For patients with chronic conditions or facing some other social economic barriers, it can become a very large burden to actually participate in and make it to the trial site every single time. Because of that a large percentage of patients ultimately drop out from the trial which costs a lot of money to sponsors to replace them.

The above two points were supported by data presented by Paul (Medidata)
23% of patients are unhappy with site location, 30% drop out before the study ends, 4 out of 5 sites fail to enroll the target, and 30% of studies being cancelled due to lack of participation.

COVID-19 – The pandemic has changed the way clinical trials are being conducted. There is an increase, and there will continue to be an increase in the number of trials that are using some kind of decentralized technology or going virtual.

R2G market study and market module shows that in 2021 there were about 1000 trials that were using digital tools. In the next five to six years, the number will go all the way to six thousand.

WHERE VIRTUAL TOOLS HELP IN THE CLINICAL TRIALS.

The decentralized clinical trials tools can be used throughout the clinical trial process. Some of the steps in which novel tools are used are:

Study design – real world data is increasingly becoming more popular in deciding where to place physical sites, as well as to find, for example, patients around the world with different rare chronic diseases that could participate virtually in the trial.

Onboarding and patient engagement – two major areas where digital tools can assist. Telehealth, coaching via app, as well as patient notifications can help with seamless onboarding and better engagement, which leads to increased patient retention.

Data collection & management – wearables can collect real world data 24/7 remotely. Using mobile phones and apps instead of having to record the data on paper as it happens at the trial site, can improve the quality of the data and its management.

Looking at the market landscape, different companies are offering services at different parts of the clinical trial value chain. There are six archetypes that are currently active in the market and there are a lot of partnerships as well as acquisitions in the market. (For more information on business models, check out R2G’s DDCT market study).

HOW DDCT AFFECT PATIENTS & PROVIDERS.

Today, there are between 300 – 500 vendors selling a DDCT solution in North America and Europe. Contract research organizations are dominating the overall clinical trials landscape and a lot of them are interested in adding digital tools. Larger players will continue to dominate the market and partner or acquire companies to run their digital clinical trials.

Many of the DCT companies claim to provide 6 major benefits to the overall clinical trial: Improved patient recruitment, Improved data quality and quantity, Improved patient and HCP retention, Improved patient adherence to treatment or medication, Increase in patient diversity and patient centricity & Reduction in time and costs. (To dive deeper into each benefit, please read our latest article with “Proposed Benefits of DDCTs“)

KEY TAKEAWAYS FROM THE PANEL DISCUSSION WITH OUR THOUGHT LEADERS

• Technology vendors are the innovators. There is a need for more collaboration between vendors and Pharma companies in the DCT space.
• At present, there is a lot of hype around DCT. There is also a growing interest from investors.
• Sponsors need evidence that DCT are as good as traditional trials. Today, there is no such evidence – the head-to-head comparison is missing.
• There is a need to raise awareness around DCT and educate the sites, as well as the internal stakeholders within the sponsors.
• Sites see more research opportunities created by DCT. CROs acquire more platforms or use such to run digital clinical trials.
• It is important to introduce new models to sites and to work together with sites.
• In the future we might need less patients per trial because we are able to collect more data per patient. Using wearables provides us with 24/7 real-world data flow that captures different insights.
• Sheer complexity of the trials – from a scientific point of view trials have become more complicated looking to answer all the research questions. In addition, trials are becoming more complex because new trial partners have come onboard.
• There is a diversity in clinical trials, but they are not diverse enough. A lot more needs to be done in this direction.
• Digital therapeutics and digital trials are the perfect marriage. DTx companies have a huge potential to drive the digital studies market.
• The pandemic has accelerated trends we were already seeing in the clinical research space, driving the increased use of technology-mediated engagement with patients.
• When it comes to virtual trials there should be a seamless process. The patient should not use several different interfaces.
• Rise of empowered and educated patients – there is no typical patient within the clinical trial space. For example, a patient can be highly educated, or a patient can be very engaged with his/her disease or a patient that is interested in the commercial product.
• Medidata shapes its technology to better support patients’ journey. Introducing the trial, onboarding, data collection via wearable & sensors, analysis of the data, etc. The company is capable and has run totally virtual clinical trials.
• With Curebase approach a lot of people in rural areas can be reached to participate in studies, or doctors can more easily participate in the clinical trials or as mentioned find and retain patients with rare diseases longer in the studies.
• M-sense Migräne by Newsenselab and their own virtual clinical trial has proven that it is possible to successfully design a DCT process to recruit and engage with thousands of patients. During the pandemic out of 2000 patients, 1660 have started with the baseline which takes 28 days. 1/3 of the patients stayed in the baseline and 2/3 of patients are out of the trial but want to continue with the usage of the intervention. This fact is very impressive on its own!
• Technology is getting better, more available, and cheaper. It is becoming more and more a key part in our lives; thus, it will be used more and more within the clinical space.
• The US is leading in terms of innovation & investment. Most of the novel ways to conduct trials happen in the US first and then they come to Europe. Regulation is a big barrier in Europe.
• In 5 years, most trials will be at least hybrid. Trial sponsors will have to use digital tools to recruit and engage those millions of patients enrolled into clinical trials.

What will the future be like? After the pandemic are we going back to the old ways of conducting clinical trials?

One of the remarkable things we saw in the pandemic is how quickly regulators have responded to the situation. We have also seen that the technology is ready, and it can be used to create patient-centric solutions to run clinical trials, better engagement and improved data flow, quality and quantity.

In her presentation, Katri (Curebase) shared with us an interesting view on the “Next evolution of DCT’s“ – Real-world settings, Digital endpoints, New models for sites, BYOP & Community providers.

DCT will create more research opportunities to be offered or a chance for a patient to participate in more clinical trials. It is all about bringing clinical trials where patients are, no matter whether a patient is at home, on a holiday, in the supermarket, etc. DCT can assist in that, making the trial more patient friendly and this will also significantly support patient retention.

One aspect that DCT and clinical trials stakeholders should still think about is when different trial sets are merged. What if one clinical trial has two trial settings – one hybrid trial setting where the patient can choose whether they want to come on site or stay at home and then one has the conventional trial setting where everything happens the old-fashioned way. In the hybrid trial, for example, one is using a wearable whereas in the conventional trial one is not using a wearable. Can the data generated through those settings be really pulled? It really depends.

When we look at the future, in the majority of cases it is not going to be an all or nothing thing – 100% virtual or traditional. For more than two decades virtualization has been run, and at present the market is more and more excited about bringing innovative technology together. All DCT market stakeholders are trying to improve the patient experience but also trying to improve the quality of the data.

At R2G, we welcome any opportunity to discuss and exchange opinions and ideas about the DDCT market. Share your thoughts with us in the comment below or get in touch with Stela Nikolova: [email protected]