Op-ed: Missing Elements of the Discussion on Decentralized Trials

The discussion on decentralized clinical trials (DCTs) has been brought to the forefront in the wake of the COVID-19 pandemic. Most notably, almost all conferences I’ve attended recently have a session or track allocated to the topic. However, a few key issues are still missing from this discussion.

Firstly, the conversation should pivot to how we can make clinical research participation as flexible as possible for people. Secondly, the technology underpinning a lot of decentralized trial aspects needs to be re-engineered from both a usability point of view so we instill confidence in those using it, and an integrated point of view so we don’t repeat the same administrative hurdles felt in today’s traditional trials.

Finally, if sites are to evolve, their business must recognize the research direction and start implementing change now to facilitate a hybrid model between decentralized and brick-and-mortar solutions.

The Magic Word: Flexibility

Participants need to have flexibility and choice in their trial participation. Making clinical research 100% decentralized is not what participants want.

According to data from non-profit, Fair Health, telehealth claims have steadily declined since the pandemic has eased and in-person services restarted. This suggests when it comes to health and clinical research, people still want physical options rather than solely relying on tech.

The model likely to run in the long term is a hybrid between physical sites with in-person appointments and the use of decentralized tools. Telehealth is part of our future lives, but it won’t necessarily dominate.

Having said that, telehealth usage is significantly higher now than before the pandemic. There is an opportunity for site businesses and tech companies to work together on solutions, paving the way for more merger and acquisition (M&A) activity in the space.

This hasn’t happened yet because the valuations of these two types of businesses are not aligned. As we see the gap between the two sectors close, it will be easier for business opportunities like this to come to the fray and the site industry to consolidate along tech lines.

Improving Tech Will Improve Confidence

The technology used in decentralization tools is not at a level consumers feel comfortable with. When looking at the technological maturity of the health sector compared to other industries like energy, financial services, and consumer, the consulting firm BCG found it lags behind.

Most devices feel like they are still in beta mode. As consumers, we are used to seamless user experiences with the tech options we interact with every day. For example, the likes of Amazon and Grubhub have set the bar very high.

We must also consider the people using these tools. The age of people taking part in clinical research tends to skew older and from lower social-economic backgrounds. This makes it more difficult for them to access digital infrastructure. It also requires a higher standard for usability needs.

Customers need to have confidence in the tech we’re asking them to use. In turn, they will have confidence in us as service providers. We need to re-engineer the user interface (UI) of health technology down to simple use cases like keeping an eDiary.

Changing Roles of Sites

The COVID-19 pandemic provided motivation to turn to more decentralized options in order to keep clinical research moving. Even though I recognize and agree with this trend, the question remains: How quickly will it accelerate in a post-COVID world?

We must remember this industry works on evolution rather than revolution so my bet is it will be a slower burn than some people think. Nevertheless, sites have a responsibility to keep up with this shift.

Site employees often act as a first line of support for participants—especially when tech goes wrong and participants need support. In fact, in some cases, I’ve seen instances where only site staff can contact tech providers’ helpdesks instead of participants.

We need to ensure our employees feel comfortable with the technology we’re asking participants to use. In some larger sites, I predict entire roles dedicated to supporting coordinators with tech needs.

Future Directions

Improving access to clinical research is in everyone’s interest. The race to find a COVID-19 vaccine was an incredible awareness-raising moment for the industry.

It raised awareness among tech providers who are solving age-old problems in the industry with new solutions. Equally, it raised awareness of taking part in clinical research among the general public.

If we capitalize on this momentum and make a meaningful impact on the industry going forward, we should embrace a new flexible model. At site level, we have a unique advantage of direct interaction with trial participants and are a firsthand witness to their needs for a positive trial experience.

We will always need physical sites when it comes to dedicated clinical research. Their role just might look slightly different. People working at sites need to show leadership now and embrace digital change, otherwise they will be left behind.

How is your organization adapting and succeeding in a decentralized landscape? Hear from Dr. Paul Evans and other industry leaders on practical strategies to implement moving forward in our on-demand symposium, Adapting, Adopting, and Succeeding in a Decentralized Landscape. Watch now.

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