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“In the future there will be no difference between conventional and decentralized trials”: An Interview with Rebeca González Vicedo

We interviewed Rebeca Gonzáles Vicedo, the Director of our Decentralized Clinical Trials Department, to learn about her work.  Read this interview to find out about her interesting insights on Decentralized Clinical Trials (DCTs) and which unique perspectives emovis has combined to offer its comprehensive DCT service.

 

1. When and how did you join emovis? What did you do before that?

I joined emovis in January 2017 as a Project Manager for the Homecare Visits department. Before that I worked as consultant supporting small and medium enterprises from Spain with their internationalization strategy in Middle East. I also worked on a project basis for several companies, like when I worked for an exciting project in Nepal to support the development of a trade network among South Asian countries. I had always been interested in the healthcare sector, so when life brought me to Berlin and I learnt about emovis, I decided to give it a try and start my new adventure in the clinical trial world. I fell in love with clinical trials and the emovis team and I have been here ever since!

 

2. You were Director of Homecare Visits at emovis. Now you are Director for the newly founded Decentralized Clinical Trials (DCT) department. How did you get here?

In 2019 I started my role as Director of Homecare Visits. It was a very exciting period in which we grew a lot in terms of geographical expansion and team size. Together with my team we were involved in supporting over 100 hybrid trials with the Homecare services. Those expertise and experiences are a great basis to keep expanding into other elements of decentralized trials, and that is why in 2022 emovis decided to dedicate specific resources to support the expansion into DCTs, with me leading those efforts. As Director of Homecare Visits, I learnt a lot to prepare me for this role, especially about working with hybrid trials and the importance of aligning the expectations of all stakeholders through clear communication.

 

3. What exactly are DCTs? What services do emovis offer in the area of DCT?

A DCT is just a regular clinical trial that includes decentralized elements. emovis offers a host of services that include our Dedicated Study Site, Homecare Visits, a Virtual Study Site, Network & Support Investigators, and a network of local healthcare providers. Our services are growing and these DCT elements can be combined with one another. In this way we can customize our DCT services for the needs of each unique trial.

I would like to highlight that clinical trials can be decentralized to varying degrees. We offer fully conventional clinical trials using our Dedicated Study Site in Berlin. We also offer hybrid DCTs, and have been doing so for about 11 years, via our Homecare Visits Service and with our Dedicated Study Site. There is also the option of fully decentralized clinical trials. So, depending on the study, the trial can be customized to suit your and the patients needs. It’s important to reiterate that not all studies can be suitable for full decentralization and that is why our service are arranged in a sliding scale, where we can pick and choose elements from different degrees of decentralization.

 

4. Decentralized Clinical trials are expected to have many advantages - for patients, for the study site and for sponsors. Could you please explain this more in detail?

Of course. Including the right DCT element into a trial can make patient centricity a reality and have the potential to bring with it many more benefits compared to more conventional approaches. Some of these benefits include a significant improvement of the patient experience by reducing the burden associated with participation. A good example of this is reducing, or even eliminating, travel for the patient. DCTs may also enable an increase in patient diversity by opening participation to a broader patient population. That is because, when there are less barriers to participation, like travel for example, more people are incentivized to participate. Another benefit is reducing recruiting times. This again goes hand in hand with lowering or eliminating barrier for participation. One more upside DCTs could offer is decreasing dropout rates. This is usually a result of promoting better patient engagement but also a result of decreasing time and travel burdens. Lastly, another interesting benefit of DCTs, is contributing to better compliance (e.g., via reminders to complete online diaries). As you can imagine these are some of the most prominent benefits, but there are still quite a few more.

All in all, these benefits lead to faster completion of studies, therefore saving time and cost, and more importantly: Therapies reach those who urgently need them most.

 

5. In your opinion, what are the biggest challenges and what needs have to be paid special attention to when conducting DCTs?

There are several challenges when it comes to the implementation, but I would highlight lack of awareness around what DCTs are and the fear of change as a big challenge. It is essential to understand that DCTs are not a magic solution that will make every clinical trial better and more efficient. There is not one unique DCT solution that will fit every trial, but a toolbox of different decentralized elements that, if well-used, have the potential to make trials more flexible and efficient.

Engaging all stakeholders (patients, study sites, sponsors/CROs) in an early stage is key to design a trial that can yield the benefits of including the right decentralized element.

 

6. Do you see a shift in awareness about DCTs, especially since of COVID-19?

Yes, more attention is being paid to the topic and so many people are still confused about it and even afraid of DCTs. The reality is that DCTs have been happening for a long time already. We’ve been conducting DCTs in the form of hybrid trials for 11 years already. DCTs aren’t an “all or nothing” tool and there are many degrees of decentralization. Additionally, not every trial can or should be decentralized.

 

7. When you look into the future: How do you assess the development of decentralized services in clinical trials over the next few years?

With time, I see the use of decentralized elements as a standard, not meaning that all trials will be decentralized, but that the use of decentralized elements will be considered and adopted for those trials and patient populations for which it makes sense. So hopefully, In the future there will be no difference between conventional and decentralized trials, but we speak of clinical trials and use all available tools, including decentralized elements, to design trials that engage patients and can be run efficiently. 

Additionally, I hope that the development of the legal framework and regulations keeps up and allows for a coherent and less fragmented working environment within the European Union, but I am afraid that will take some time.

emovis will keep working on creating awareness around the DCT topic, and developing solutions that work for patients, sites, sponsors and CROs.

 

8. What would you say is the biggest strength of emovis when it comes to conducting DCTs?

I think our biggest strength lies in the perspective we have from both our Dedicated Study Site and our Homecare Visits Service. Running these services for many years has given us a lot of expertise, which has carried over in a powerful way when integrating them for DCTs. A lot of other sites may be unfamiliar with integration of other services that enable DCTs and other homecare providers might lack the site perspective. This is really where emovis can shine. 

 

9. What would you like to tell our readers at the end?

I would like our readers to learn more about all the interesting topic work on by reading our blog posts here. emovis is always working on fine tuning and enhancing existing DCT services according to the needs of Sponsors, CROs and patients. As you know, our mission is to further medical progress and we believe that DCTs play an important role in living up to this mission in the future

 

Thank you so much for your time today! This discussion about DCTs is really interesting and seems to be one that is always evolving. We hope our readers also enjoyed your insights on the topic and we welcome them to visit us here for more information about our DCT services.  Our next interview will continue, with none other than our CEO, Dr. med. Bettina Bergtholdt. We will continue part of our discussion around DCTs with her. Should you have any further questions please write us on feasibility@emovis.de.