Regional Considerations of Decentralized Clinical Trials

Last Friday, I participated in a very interesting talk on Clubhouse about the Regional Considerations of Decentralized Trials hosted by the people with probably the most experience in the space – Craig Lipset and Amir Kalali from DTRA and Mark Campbell. The organizers and speakers did a great job outlining some of the regional hurdles to planning a decentralized trial and I am using the opportunity to share with you my notes. I hope you will find them helpful.

The main speakers were Jane Myles (Director DCT at Covance) and Noolie Gregory (VP of DCT Syneos). They both shared from their first-hand experience how they and their teams have managed to overcome hurdles and what should be the main regional considerations.

In a summary, the main regional considerations when planning DCTs are:

  • Availability of local vendors – my observations are that there are some global leaders in a few of the service categories that cover most of the regions. If you need to choose a local vendor, you can check out our VCT (DCT) vendors catalog with 140 different providers.
  • Local regulations and acceptance
  • Cultural specifics – this one was quoted as the most difficult to overcome.

Additional challenges and thoughts:

  • Regulators are open to discuss a remote approach with patients. Yet, this usually means more time negotiating which leads to postponing the starting time. This is why it’s important to know when and what has been done in the country/region and use it as a reference. At TrialHub we built a special filter on top of clinical trial registries to identify exactly this.
  • You always go with the traditional country selection strategy (patient recruitment optimization) and then DCT is an instrument to boost patient recruitment and engagement. DCT is the tool, not the purpose.
  • If regulators can go back to basics and say

    We accept everything if you:

Maintain data integrity

Keep patients safe

This will solve a lot of hurdles with understanding what can be done in a given country/region. It will provide more freedom to companies to be flexible with their strategies on optimizing patients’ experience.

Best practices in deploying DCTs:

  • Select the best-in-class partners (data privacy, home nursing teams, remote medical devices etc.)
  • Get the sites and patients perspective upfront and make sure they are aligned with your strategy;
  • Work with local colleagues to get insights and understands the local landscape. If you don’t have a local office or anyone that can help, perhaps our Country Intelligence Group can help here.

One more thing to consider too!

Jack Evans (Director at Pratia) mentioned that we need to be careful with sites. It can be a massive financial and operational burden on sites as now they need to have the capacity to support patients both remotely and at the site. As he said, thousands of sites are going under each year and we need to make it easier for sites not more complicated.

First published on LinkedIn.

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