Scaling your global hybrid-decentralized study
Whether you're planning your next clinical trial or looking to gradually expand your current hybrid-decentralized trial there are numerous decentralized clinical trial approaches and steps you can put in place for your projects, such as virtual visits within protocol, schedule of events (SoE), and ICF’s that can make scaling your study become a turn-key process.
While the definition of a hybrid-decentralized study differs depending on who you ask, the fact is that the term "decentralized" refers to moving primarily in-clinic studies, outside the clinic. The goal isn't always to walk away from the clinic entirely, but instead to offer different approaches that can make your study run more effectively, with a greater focus on inclusiveness and patient centricity. Decentralized clinical trials gained popularity last year as the pandemic limited the ability to be on-site for participants, and the rapid adoption of hybrid-DCT approaches helped many Sponsors mitigate the risks from long-term delays and project cancellations.
While that made sense with a surviving mentality, it’s clear that customers are not giving up DCT approaches, instead they are embracing them with a “thriving” mentality. They are even looking to expand their studies globally in 2021 and beyond. So, the question remains—how can you scale your hybrid-decentralized study using DCT technologies?
Below are seven best practices that will help your scaling efforts.
- Determine the areas, design, and assessments that will utilize a DCT approach. There are some therapeutic areas that are well-aligned and easier to adopt DCT approaches which should be prioritized. In comparison, therapeutic areas such as oncology require a more measured transition. However, just because you cannot fully virtualize a trial site, it doesn't mean that a DCT approach can't help an oncology study work differently.
- Set-up one global platform for configurable, fit-for-purpose study use. You may need certain settings and abilities for one study but not another. Having a single platform with multiple instances allows you to make it fit-for purpose for your current study and gives you the ability to adapt it to the requirements of a different study.
- Confirm the countries that will utilize DCT features with a regulatory approach. When you think about scaling or going global with DCTs, you can and should start small. Instead of trying to enter 30 countries, you can start with a few where you have affiliate support, location support and infrastructure to support your study -- giving it the highest probability of success.
- Ensure all external system and secure data transfers are consistently set up.Being able to get things set up once in advance becomes important because the opportunity to scale DCTs comes in the form of having built out templates and technology integrations. If you have a bunch of sensors and systems that you need to implement, doing 4 or 5 for each study is going to help you rapidly speed up that scaling process for future trials.
- Finalize all assessment libraries, sensors, patient-facing copy, branding, etc. Things that take a long time to get through, like MLR approvals, are best to build out in advance. Getting through and finalizing something like eCOA and setting it as a standard provides reusability in the future and avoids you having to start from nothing.
- Confirm the global device approach and local distribution depot strategy. There are different options like home health distribution, direct to site, or full kits at depots that distribute kits that can be used for DCTs. However, there are regulations where some devices can't be used in certain locations so you will want to plan this out at length.
- Standardize training for sites, home health and study teams with 24/7 support. The ability to support and give ongoing training and education is critical. You must be available for people as soon as you can, meaning that you have continuous support.
If you want to learn more about one or more of these ways to scale your global hybrid-decentralized study, you can watch the webinar with THREAD’s CEO John Reites and Takeda’s Head of Clinical Innovation, Trinette Mitchell. Click here to get your recording.