From in-person trials to DCTs and back again: Why has implementation of remote trials been so challenging?

Evidation Fireside Chat with Joyce Nortey, Senior Director of Clinical Operations

In recent years, the clinical world has witnessed a seismic shift towards decentralized clinical trials (DCTs), much in part due to the COVID-19 pandemic. DCTs have emerged as a powerful alternative to traditional clinical trials, allowing for greater accessibility and convenience for participants. Evidation, a pioneer in this space, has been conducting DCTs for almost 10 years, even prior to the pandemic.?

Individuals on Evidation’s Clinical Services team, in particular, are leading the charge to make DCTs more accessible and inclusive. We sat down with Joyce Nortey, Senior Director of Clinical Operations, to discuss the potential of DCTs to benefit all clinical trial stakeholders (e.g., participants, clinical trial staff, and sponsors) and some of the obstacles keeping companies from realizing that potential.

Get to know Joyce

During her undergraduate degree majoring in psychology with an emphasis on psychopathology, Joyce worked as a research assistant for an NIH-sponsored study on child obesity. After graduation, she moved into social work, helping support street/shelter-dwelling families experiencing homelessness, before returning to clinical research within drug development. During her first year in the industry, she completed a Clinical Research and Conduct and Management Certificate from UC Berkeley Extension. Joyce attended the University of San Francisco to complete a Masters of Public Health and Masters of Science in Behavioral Health with a focus on involving the participant voice in the clinical drug development cycle.?

Across her career, she has worked with Phase 1-3 drug and medical device development spanning central nervous system, cardiovascular disease, oncology, chronic pain, and immunotherapy studies. She joined Evidation 4.5 years ago to focus on innovative solutions, following a variety of positions focused on participant-centric recruitment and retention within clinical research, clinical program management, and medical affairs. At Evidation, her path to the Senior Director of Clinical Operations took her through being a team of one spearheading Evidation’s strategic involvement and operationalization of GCP-regulated clinical research using Evidation’s well-established consumer-facing platform.

Although most of the industry recognizes the benefits of DCTs to make research more accessible, convenient, inclusive, and representative of real life conditions, the adoption of this model seems to have slowed. You just returned from a conference for clinical operations — could you share some of what you learned about the challenges to implementing DCTs at the conference?

One of the really interesting sessions I attended, called “The Rise and Fall of Decentralized Trials,” highlighted some of the challenges. In it, the discussion centered around how all study stakeholders, including sites, sponsors, and participants did not want to be involved in DCTs. Some in the industry say that we need to go back to traditional in-person studies because they're cheaper and we just don’t know how to do DCTs well.?

However, others, including myself, argue that DCTs weren’t implemented correctly during COVID. Sites and participants weren’t adequately educated nor presented with training or options around the potential for implementing DCTs. Devices might have been provided by the study, and participants didn’t know how to use them or already had their own and did not want to manage a second one. In addition, there have been too many systems to piece all portions of the clinical study together, which all require separate logins from the study staff as well as the participants. In fact, I’ve heard site complaints about having to log in to seven or eight different platforms to access the eConsent program, send and review surveys to participant devices, pay participants, etc.?

I support the argument that we need to re-evaluate the implementation and hybridization of DCTs rather than set them aside completely because they do have the proven potential to increase access to clinical studies for a larger portion of the population, improving our ability to obtain more representative findings.

Why do you think there’s been such a pendulum swing from conducting trials completely decentralized back to completely in person?

With the push for DCTs during the COVID pandemic, I think everything just happened too quickly, the industry wasn’t ready, and DCTs were executed without actually thinking of it as a different model. In-person trials were essentially just “digitized” by adding devices or online assessments. Now, as people are taking a breath, they’re starting to question the sustainability of that approach.?

Also, the industry still wants to do things fast — we know we need to educate, involve, and train participants and sites, but that can be a lengthy process. We don’t want seven or eight different platforms, but quickly finding and vetting a vendor who can provide a single platform that does everything is challenging. It seems much simpler to choose specialty vendors for each function; however, the risk is that they are not mature enough to support a broad range of trials, and the integrations between systems can be complicated or just not work at all.

It's also very rare that sponsors and study staff are only working on one trial at a time, and having to keep track of each system for each particular task (e.g., study plans, GCP-related documentation, participant assessments) is cumbersome. From the participant standpoint, it is inconvenient to understand and navigate various interfaces without training, while being sick, or while just dealing with life. When study participation becomes a chore, retention rates are lower, withdrawal rates can be higher, and the rates and likeliness of future participation in clinical studies are placed at risk.

To help address some of the challenges while retaining more convenient remote elements, there’s also been discussion within the industry of adopting a hybrid approach to clinical trials, in which there are both remote and in-person elements. What’s your take on this strategy?

Absolutely. I think the hybridization of clinical trials should receive a closer look, especially for specific indications that require in-person assessments. For instance, MRIs for an oncology lesion study typically need to be conducted in person, but some survey-based assessments could be completed remotely. One of the benefits of a hybrid model is mixing site visits; home visits by a phlebotomist, for example, going to a participant’s home; and fully remote digital assessments. In the end, hybridization will be an important strategy for clinical research but will require more planning and thinking outside the box of how we have typically approached research.

What are some of the best practices that you’re aware of or would recommend for implementing DCTs?

I think best practices for DCTs could be broken into two main categories: (1) adopting a participant-centric approach and (2) designing and using purpose-built technology.

Participant-centricity is my favorite thing — it was actually the topic of my thesis. To do it well, it’s important to consider it at the earliest stages of study planning.?

At Evidation, we believe in giving people a choice. It starts with an invitation to join the platform, which is followed by just asking individuals if they are interested in participating in a study — for each and every new study. In addition, as we develop studies, we try to allow participants to use their own devices as much as possible — or at least give them the choice of using a provisioned device or their own. We also prefer to offer the choice of things like a clinic or telehealth visit or going to a lab or having a mobile phlebotomist going to the participant’s home, when possible.

Also, despite someone’s overall education level, health literacy tends to be really low, and we need to recognize that. That’s why we also provide education and content on a variety of health-related topics that could be of interest to our members, even beyond currently available studies.?Our approach to content involves intentional design for appropriate literacy levels, how we phrase questions, and using inclusive language. We also include a variety of media such as videos, documents, short explanations, and visuals to support all learning styles.?

Taking the time to determine which assessments could be completed remotely minimizes the time someone might have to take off work or away from other responsibilities to visit a site. I heard a story? about a caregiver who had to fly from Green Bay, Wisconsin to Florida to complete surveys for a rare disease study. I thought to myself, was it really the case that there's no other way to do that? I think consciously decreasing the burden of research is huge for participant centricity.?

Just touching on inclusivity again for a moment, there’s a notion in clinical research that diversity only means ethnic diversity, which yes, it does, and that is very important. However, diversity also includes representation across genders and gender identities, geographies, age, socioeconomic status, and more. Evidation has included questions about gender identity when collecting demographic information for a long time now, which is something I’ve realized not all companies do.?

I truly believe that our inclusive, participant-centric approach, which includes holistic education, choice method design, and automation, drives our high engagement and retention rates for studies that we’ve supported.

It’s always interesting to hear about features that we have in our platform that might not be considered “normal” throughout the industry. It’s a nice reminder about things we should be talking about more often. The other best practice you mentioned was purpose-built technology. Could you tell us more about that?

The second best practice I mentioned was around technology, which is a really important part of successfully implementing DCTs. In fact, some think that’s all you need. However, at Evidation, we argue that how you use that technology is just as important, and I’ll return to that thought in a second.?

At Evidation, we established a foundation for DCTs years before the pandemic hit. The foundation is our platform, which is flexible enough to seamlessly support both full DCTs or hybrid trials. It also truly supports the study from start to finish in a GCP-compliant manner, from recruitment and consent through data collection and analysis — all based on a comprehensive data privacy and security infrastructure. Plus, we’re able to offer direct support to participants with the click of a button. And all of this is within a single platform, relieving the burden of accessing multiple platforms for different tasks.

I’ve observed that some sponsors who had tried to develop DCT technologies in house are moving away from that, which I understand, because it is challenging. Now, they’re looking for vendors to partner with, and it’s important, but challenging, to find one that has the experience to execute a DCT well. We have many examples of successfully implementing DCTs, including?a study on antibody levels following a? COVID-19 vaccine. Individuals could participate remotely from anywhere in the US, and it helped collect data on long-term immune response, which can be key to making public health recommendations for vaccination.?

Going back to how the technology is used, I think we’re unique in our ability to help clients design, execute, and analyze DCTs. We have a great team of really knowledgeable people who have been doing this for years, and it shows in the end-to-end support that we provide to find a solution that overcomes many potential challenges across numerous indications.?

This is still a rapidly evolving area, and we get excited about innovating and building our learnings into our platform for a better experience for everyone involved.

It seems that eConsent continues to be a sticking point for many. What are your thoughts about the challenges for that specifically and the potential solutions?

I think, at Evidation, we’re always surprised when this comes up because we’ve had eConsent capabilities for many years now. In fact, we’ve consented tens of thousands of individuals to studies using our eConsent. We worked diligently to make sure that our eConsent meets GCP and other regulations, that participants understand what is expected of them through multimedia explanations of the study process and activities such as illustrative videos, and that electronic consent is verifiable through the platform. After participants electronically sign their consent documents, an executed copy is immediately emailed to them for their records, and a copy also lives on their study dashboard (within the same platform) for the duration of their participation to ensure quick and easy access. Importantly, participants don’t have to move between applications once they’ve consented, yet they are still able to contact participant support directly at any point during the consent as well as during the study process if they have questions.?

We’re always happy to talk more about our eConsent process, and I encourage anyone who wants to know more to reach out for a chat.

To wrap up, what do you think the future holds for DCTs in the Evidation platform?

I think the large membership on the Evidation platform and our efforts to diversify that membership set us apart in terms of the broad range of people who will be participating in clinical research in the future. I’m excited about the potential to segment that population to really gain deep insights into health and potentially personalize our efforts to fit the specific needs and health-related goals of individuals.

By continuing to collect wearable and activity tracker data, we’re also able to start developing algorithms for robust digital biomarkers. And we have the opportunity to really change the landscape of preventative medicine instead of identifying people when they've already been sick for a long time. This applies across all models from infectious diseases like the flu and RSV to chronic conditions such as cognitive impairment and oncology. I've seen a lot of studies looking at data from wearable activity for people with different tumor types combined with device and drug development, and I think the possibilities are endless.

To learn more about Evidation's work in decentralized research, click?here.