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Decentralized clinical trials: What are the challenges to come?

Decentralized clinical trials: what are the challenges to come?

Clinical trials were re-thought thanks to the pandemic. Decentralized clinical trials (DCTs), at first seemed like a temporary solution. Yet, as time went on, pharma began to pick up on some of its main advantages, especially flexibility. Can clinical trials be permanently shaped by a hybrid or a remote model?

The truth is that decentralized clinical trials were not a new model in these procedures. Pfizer launched a virtual trial back in 2011. At first, this didn’t catch on as much with pharma in general. Between the second half of 2019 and 2020, ZS’s DCT database reported data from more than 1,000 trials.

This means that this new model for clinical trials has caught on. And it’s here to shape these procedures permanently. More than one benefit comes from this new model of trials which we will be exploring further in this text.

Why are Decentralized Clinical Trials here to stay?

Thanks to COVID-19, there was a permanent shaping of the balance of tradeoffs in pharma. New challenges rose with this decentralization. Yet the benefits of DCTs have shown to be worth the investment. 

Applied Clinical Trials have highlighted four main points that show that these clinical trials will have their place in post-pandemic reality. In the next topic, we’ll introduce some of them.

The advantages of DCTs in a post-pandemic reality

  • Technological maturity: The evolution of technology is one of the main factors that influence the rest of the topics mentioned. Investments in this sense are also contributing to a decentralized model. We can expect more end-to-end technological solutions fit for DCTs.
  • Increased investment in DCTs: Pharma companies are creating new possibilities for DCT models. There are technological options that can operate several procedures at scale. Not only that but as well as new group possibilities with dedicated leadership.
  • Digital patient experience: In the midst of all this, we can’t forget the increasing experience that patients also have with the digital spectrum. Elements such as digital pharmacies or telemedicine helped to enhance the expectations of their clinical trial experience.
  • Easier regulatory direction: Thanks to COVID-19, several regulatory agencies, including the FDA, made an effort to clarify their guidance on decentralized practices. It’s predicted that in the case of DCTs, the FDA will use its new Digital Health Center of Excellence to help these procedures take place in an easier regulatory landscape.

What are the pros and cons of Decentralized Clinical Trials?

The main advantage related to decentralized clinical trials has to do with the patient-centric approach. One that helps to address a variety of their needs. 

All in all, this new model creates a more streamlined experience. It applies to both the organizers and the participants in the trials.

Among them, we can highlight the fact that they can help reduce the time factor that defines in-person visits. There’s also the fact that DCTs enable wider patient access. Especially for people living in either rural or underrepresented communities. 

In short, there are a lot of advantages that open up a conversation for comparison of DCTs with traditional trials. Decentralized clinical trials also ease the clinical development process. Thereby helping to generate more conclusive evidence

The fact that it’s a decentralized process also helps the sponsors. Not only can it increase compliance, but it can also reduce drop-out rates. The fact that this new model can help collect more advanced data, generates a great help for evidence packages and shows the create value of these trials for patients.

The challenges of DCTs

Yet, a decentralized process means more complexity. One of the main challenges has to do with the increasing need for resources. We mean those that can help DCTs to take place with success. This also poses many challenges for sponsors in particular.

The sponsors will have many roles to play in this context. They must learn how to implement DCTs, as well as figure out what they need to do to support patients on their journeys. At the same time, they need to capture the real value of DCTs, while comparing them to traditional clinical trials.

It involves more work to properly understand the impact that this new model can have on patients. When it comes to regulations, DCTs are still developing and lack consistent standards. In the initial phase, sponsors will have to concentrate on priority markets.

How can Decentralized Clinical Trials be implemented successfully?

For this decentralized model to work, it has to be properly implemented. This means that the traditional way won’t always work as a blueprint to create a new model. Pharma companies in this sense will need to take a more comprehensive approach.

There needs to be a focus on one core goal for the whole process to be perfectly reliable. Pharmaceutical companies need to reflect on how they can answer a certain question from a digital perspective. Consulting with DCP support providers must happen to discover the best method to achieve the trial’s goals.

One must always remember that some therapy areas fit better than others in a decentralized clinical trial. Right now, areas such as cardiovascular, diabetes, and neurology are the most common areas for this approach. In the future, this might be adaptable to other areas. But for certain therapies, this may never be applicable.

It’s important to keep in mind that, as these procedures become more common, patient experience and data collection will have a bar raised. DCTs will evolve in unimaginable ways in the following years, changing the performances of many current clinical trials.


One thing is for certain: pharma companies are not trailing this road alone. Many investigators, patients, regulators, and sites are also willing to embrace this change in this procedure. This will be one of the main elements which will contribute to the customer-centric approach that healthcare will be walking toward in the future.

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