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What we've learned after conducting 100 DCTs

Cassidi Williams

How do you, in a measured way, conduct and scale a decentralized trial? We may not have decentralized trials entirely figured out as we are still learning, adapting, and trying to optimize the decentralized clinical trial approach to be a better experience for everyone involved, however, we can share what we have learned after conducting 100 decentralized studies with THREAD.

Here are 10 Insights that you can be sure to implement in your current or upcoming decentralized study to optimize results:

  1. Focus on Education - A common understanding of decentralized study approaches, technology features, and global availability goes along way and is critical to the success of the trial.
  2. Decentralization is Flexible - How decentralized a study can be designed is determined by the end points and innovation tolerance, allowing it to be adopted into virtually any study.
  3. One Size Doesn't Fit All - The implementation of DCT approaches, site involvement, content, and specific features must be configured per study for best results.
  4. Launch a Single Platform Instance - Setup one global platform with fully configurable, flexible features to scale fit-for-purpose use on studies. Essentially as you add individual studies to scale a decentralized trial approach you want to be able to configure and turn on/off features that you need to make a DCT approach fit-for-purpose on a study.
  5. Confirm Global Applicability - You have to know what you can and cannot do in certain countries, so consider global regulatory and data privacy requirements to utilize specific decentralized study features.
  6. Mature Workflows - If you want to add a new feature, having the ability to setup automated process steps and handoffs in a platform between study stakeholders is just as important as the features included.
  7. Ask Patients and Sites - The request to ask patients and sites about their participation and about what they need to be successful within a DCT provides helpful insights. They're supportive, provide ongoing feedback, and offer honest NPS scores.
  8. Enhance Study Training - No amount of training is enough. Ongoing training for patients, sties, home health, and study teams requiring 24/7 multilingual support is needed and should be available even after the study is launched.
  9. BYOD vs BYOD first - BYOD requires a large range of supported OS/devices and should include a "BOYD First -- Provision Second" approach so that kits can be sent to sites and as patients come in, they have the option to use their phone that meets the criteria. If they don't, then a kit can be offered to the patient right there.
  10. On-demand Virtual Visits - The use of on-demand telehealth for unscheduled visits and virtual check-ins is on the rise since they offer help to the patient as they need it, when they need it.

The fact is that, if decentralized approaches are going to become standard for sites, home health, and patients, we need the feedback and insights to keep moving this process forward in getting studies within the industry to become more efficient and provide a modern approach. If you want to learn more about what we have learned or want to discuss these in further, please contact us at info@threadresearch.com