With the acquisition of emovis, the Berlin-based, dedicated study site and award-winning pan-European homecare visits and DCT solution provider, FutureMeds became the first DCT site network in Europe. The company has already begun the process of enhancing DCT readiness throughout the entire network. Additionally, our emovis and FutureMeds teams are working towards creating a European DCT solution. It is expected to be finalised by September 2023.
Currently, there are only a few true one-stop-shop DCT sites, and, to our knowledge, there are no DCT site networks out there with high levels of DCT readiness across all their sites in Europe.
In fact, a recent study by the Tufts Center for the Study of Drug Development has shown that the adoption of any innovation supporting clinical trial execution typically takes six years for a single company and over 20 years for widespread adoption in the drug development industry. According to FutureMeds' estimates, most sites are still at least 3-6 years away from adapting DCT approaches, elements, technology, platforms, and processes. Initiation, evaluation, adaptation decisions, and full implementation cycles need to run their course at each organisation.
With the acquisition of emovis, integration of their homecare visit and DCT service, and boosting DCT readiness across the whole dedicated research site network, FutureMeds became the first European DCT Site Network.
"We're excited to drive meaningful momentum and results for our clients and patients. Speeding up the DCT adaptation process across the clinical trial industry in Europe can boost pharmaceutical R&D productivity, support and influence commercialisation strategies, and significantly enhance the patient experience, engagement and outcomes."
- Dr Radoslaw Janiak, CEO at FutureMeds
The company is now on track to unveil a European DCT solution in September that integrates the 'site and patient voice' and combines deep PI and site insights, innovative trial design experience, agile homecare solution, and operational excellence for driving R&D and improving patient experience.
“With emovis HomeCare Visits capabilities and by merging our expertise and capabilities, FutureMeds became the first European DCT Site Network providing HomeCare Visits services in 16 countries and a high level of DCT readiness across our network in 6 countries. Our Clinical Research Partners can expect effective strategic solutions out of the door, and we are very keen to improve them further together, to find answers faster, together and Deliver Tomorrow’s Medicine Today.”
- Iwona Tongbhoyai, Vice President of Operations at FutureMeds
Key building blocks of FutureMeds’ European DCT solution and offering
The team at emovis has over 11 years of experience delivering hybrid trials. Throughout these years, they have achieved deep domain expertise and built DCT solutions that are ahead of their competition.
One of the essential building blocks of emovis’ DCT framework is their DEN Innovation Prize-winning Homecare Visits (HCV) service, which emovis has been offering since 2012. Originally, this service was available only in a handful of key trial destination countries.
As the demand for home visits steadily increased in Europe, emovis extended their HCV service into 16 countries across the EU, plus the UK, and introduced other DCT elements to further support patients, sites, and clients.
By the time of the pandemic, emovis HomeCare Visits were among the most mature and high-quality solutions on the market. Nonetheless, the Homecare Visits team spent the last 3 years streamlining the service, optimising SOPs, upskilling the team, scouting countries where the service can be launched, establishing partnerships, and growing their vetted, certified nurse database with quality personnel.
Their dedicated homecare nurse database passed the 1,100 mark in early 2023, enabling the team to carry out larger-scale trials across 16 European countries relying on high-quality, vetted clinical trial-trained nurses.
Challenges Addressed by FutureMeds' European DCT Solution and Offering
"There are many European home care providers that lack the insights into how a site operates, leading to difficulties with site engagement. At emovis and FutureMeds, we understand the needs and requirements of sites, while also being a home care provider. Understanding the challenges of both worlds can be a significant advantage."
- Rebeca Gonzalez Vicedo - Director of Decentralized Clinical Trials
Justification of decentralised elements
With robust DCT and traditional readiness, and proven trial experience across the FutureMeds dedicated site network, sponsors and CROs will be more likely to engage our experts on a trial-by-trial basis. There is no one-size-fits-all DCT solution.
By consulting our experts, clients can tap into the insights of the Patient-Voice and Site-Voice and weigh up opportunities and assess anticipated risks associated with the implementation of decentralised elements in the protocol and how those should be mitigated.
This closer collaboration could also help clients make strides towards more modern strategic planning processes and site strategy frameworks that can effectively assess if novel services should be utilised.
Ethics Committee and PI resistance to DCTs
As regulatory bodies clarify guidance and recommendations and provide national provisions for specific decentralised clinical trial elements, the industry is increasingly looking into the preferences and acceptance of DCT elements such as home visit solutions. Traditionally, ethics committees and PIs had reservations about third-party solutions as the guidances weren't clear enough.
Homecare Visits also faced these challenges throughout its over 10 years of history. The team addressed this by working closely with PIs and tightening recruitment criteria based on PI and study-specific requirements and rigorous training.
To further improve the acceptance of Homecare Visits, as part of FutureMeds, the service can be offered through our sites' existing infrastructure. The latter can also cater to increased safety monitoring that typically requires in-person (on-site) visits.
Trial participant challenges
One of the major challenges of DCTs is insufficient rapport and relationship-building with participants. Clinical trial engagement, retention, and IMP adherence are heavily connected to person-to-person interaction in certain indications.
In-person visits may also be important for assessing whether patients are suitable for a clinical trial and could also help volunteers to decide whether to participate.
Homecare Visits, combined with FutureMeds' other DCT solutions, such as FutureMeds Go mobile units, can bring trials to the patients without removing the positive impact of in-person interactions between the investigator team and the participants.
Opportunities Unlocked by FutureMeds' Upcoming European DCT Solution
The European DCT solution aims to reduce the data collection burden on patients while ensuring data that is closer to real-world settings and providing a more complete data picture to sponsors and CROs by utilising home/telemedicine visits.
These DCT approaches can be particularly suitable for trials with chronic diseases, rare diseases, immobile participants, self-administrable IMP, lower safety risk profile, and confirmatory trials, where Homecare Visits can ensure proper oversight and detection of safety events.
By including Homecare Visits and other DCT elements in trials, sponsors and CROs can:
Build and maintain relationships with trial participants
Increase geographical reach
Access patient populations that would otherwise not be able to participate for a variety of reasons.
Increase diversity and inclusion
Recruit a larger number of suitable patients
Achieve higher participation rate, trial compliance and Investigational Medicinal Product adherence
Increase participant retention rate through our extensive customer service
Why FutureMeds Chose to Increase DCT Readiness across the Site Network
Despite the initial excitement and rapid adoption of DCT elements and tools during the COVID-19 pandemic, recent trials have shown a decline in DCT elements compared to the level during the pandemic. At FutureMeds, we argue that this is a positive sign. It means that organisations, both small and large, across the industry, have started to delve deeper into DCTs and examine what DCTs mean from an operational, ethical, regulatory, data hygiene, financial, feasibility, trial design, and site selection standpoint.
As clinical trial sites play a crucial role in the decentralisation process, the site landscape will continue to evolve through investment in DCT services like home health and direct-to-patient investigational products, and supporting technologies such as eConsent, ePRO, telemedicine platforms, and wearables.
However, this rapid evolution creates new site selection challenges for sponsors and CROs. Due to various factors, sites’ DCT readiness, experience, and capabilities can vary significantly, even within the same site network.
Without the ability to identify sites with the right experience, capabilities, and willingness to conduct DCTs, studies could become time-consuming, costly and, in a worst-case scenario, prone to failure. Additionally, sponsors could miss out on partnering with sites that are a good fit for the specific trial.
By fast-tracking the adaptation process, levelling up, and boosting DCT readiness across the entire dedicated research site network, FutureMeds aims to lead the way and help clients overcome DCT challenges and speed up R&D across Europe.
emovis has been a reliable, versatile service provider for phase Ib-IV clinical trials since its establishment in 2001. As one of the best study sites in Germany, emovis has recruited more than 9,000 patients in over 250 studies in 120 indications across 14 therapeutic areas.
In 2012, emovis launched the Homecare Visits (HCV) service, an innovative solution to improve the patient experience. Now present in 16 European countries and with over 1,100 dedicated homecare nurses in their database, Homecare Visits (HCV) is one of the cornerstones of emovis' DCT framework and offerings.
FutureMeds is a fast-growing independent Dedicated Research Site Network with high DCT readiness supporting pharmaceutical companies, Sponsors and CROs and contributing to research to find effective treatments and medications for all patients who need them.
FutureMeds’ Dedicated Research Site teams strive to accelerate study timelines, streamline processes, lower costs and improve data quality to help accelerate patient access to new treatments.
Through acquisitions and a strategic focus on patient experience, FutureMeds has developed qualified patient pools across Europe that enable faster patient enrolment and strong retention and help generate more accurate results.
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