Addressing the slow adoption of decentralized clinical trials (DCTs)
Industry leaders have been thinking about their approaches to clinical research during, and now in the aftermath of the COVID-19 pandemic. A spotlight was put on our practices and as we move further from the pandemic and return to normalcy, we shouldn't forget what it taught us about the way clinical trials can be [and should be] conducted.
Decentralized clinical trial (DCT) technologies provided a safety net, in some cases protecting and saving clinical trials when quarantine and lockdown restrictions were put in place. In an analysis comparing subject enrollment and discontinuation in decentralized and traditional clinical trials over the first three quarters of 2020, it shows that the adoption of decentralized technologies increased and maintained patient retention to pre-pandemic levels and even higher in some cases.
Decentralized approaches provide a more patient-centric strategy, and many industry leaders and subject experts want to move forward with the technology, however, this transition results in extra challenges and questions when it comes to those examining the operations, protocol design or feasibility of a study, such as:
- Can we do this decentralized clinical trial (DCT)? Yes, you can. Even in the most remote parts of the world you can do DCTs, and it continues to be proven time and again. Depending on cost structure and requirements, it could be more expensive in hard-to-reach areas, yet there are ways to become more efficient as you go throughout the world. Even in some parts of sub-Sahara Africa or even in the Rift Valley (region in Ethiopia and Kenya) it can be done. It will just require a more strategic approach to your protocol design.
- Are we and our sites ready to take on this project? People tend to look ahead at the DCT operational topography and use potential obstacles as a reason to just “stick” with what they know. What must be recognized is that clinical trials are becoming more innovative because of the patient-centric approach that decentralized clinical trials technology provides, allowing room for clinical trials to become more inclusive and accessible for potential participants worldwide. Hundreds of trials have successfully started and completed with DCT technologies. Getting started on your DCT journey may entail implementing a crawl, walk, run strategy in your next study. Slowly add and adopt various aspects of DCT approaches to see what works best for you and your operations. If you want to be truly effective in this endeavor, start with one piece of your trial that you cannot effectively operate without: The participant. If we start with the participant, we can begin asking the right questions about how we are positioning your DCT trial for success.
- What does adding decentralized approaches look like from an operational perspective? Slowly adding DCT approaches to fit the needs of your study will look different on a trial-by-trial basis. There are a multitude of factors that will influence your DCT approach, including; the indication, study population, location(s), end points, digital instruments, purpose of the study, etc. But, as previously mentioned, DCT use and adoption can be accomplished in small steps, such as adding eQualification or eConsent early in the participant onboarding process, adding a general Quality of Life (QoL) survey to aid in compliance and retention or, as COVID has shown us, adding telehealth as a feature set in every aspect of the participant process. Once you have this streamlined, it may make sense to adopt additional decentralized approaches or technologies like sensors or site data capture. If you have a protocol concept, synopsis, or draft and want to explore a decentralized approach, you can do that here.
- Are sites going away? No, and it's likely that they will never go away entirely because it depends on the indication of the study itself. Take type 2 diabetes for example, where we can probably rely on fewer sites than, rare disease studies, where you will likely always need more sites. It's best to follow a fit-for-purpose model, meaning each study will be specifically designed for its need.
As clinical research modernizes, companies offering decentralized clinical trial platforms need to help their clients understand the advantages of decentralized approaches while also helping those clients operationalize the technologies into their study with the best approach. This is the best way to keep moving forward with a patient-centric approach and modernizing clinical research.