Recommendations for Decentralized Clinical Trial Capabilities in the Wake of COVID-19
Editor’s note: Lilly conducts bi-annual feedback sessions with clinical trial sites to learn more about the site experience conducting clinical trials in an ever-evolving landscape. This year we focused on site adaptations for conducting clinical trials during the COVID-19 pandemic and discussed their experiences and recommendations for implementing Decentralized Clinical Trials (DCTs).
“Provide options for remote versus onsite visits which will allow sites to provide upfront or situational flexibility” -Study Coordinator in Israel
To better understand how various countries adapted to execute clinical trials during a pandemic, we conducted a series of virtual feedback sessions with clinicians from all over the world. The team and Lilly spoke to 26 sites in the US, Canada, Brazil, Spain, Italy, Germany, Turkey, the Ukraine, the Czech Republic, and Israel. Since COVID-19, sites have implemented many Decentralized Clinical Trial (DCT) capabilities out of necessity with their primary focus on maintaining participant care. Without exception, the site feedback consistently showed that regardless of what DCT capabilities are implemented, sponsors must maintain flexibility for participants to chose their preferred path, either remote or onsite.
With that flexibility in mind, we placed focus on the following capabilities: mobile nursing, telemedicine, remote data capture/eTools, online visit guides/protocols, and direct-to-participant shipping.
Tips to implement an effective and successful decentralized clinical trial for multiple touchpoints
Provide consistent mobile nursing
Consider the specific disease state needs of the participants, and provide consistency of care with familiar faces to ensure participant comfort with mobile nurses coming into their home. Perhaps include a telemedicine call with the site.
Compliance, oversight, and training of mobile nurses is burdensome and expensive, so consider embedding them at sites as flexible or extended members of the site.
Introduce visits via telemedicine
Participants must continue to feel connected to the site staff, so sponsors need to consider the specific needs of the therapeutic area and age and consider implementing technology platforms that participants and site are already using .
Default telemedicine visits are acceptable for routine visits as long as there is an option for onsite visits if the patient prefers.
Consolidate remote data capture with apps and eTools
Sites and participants are struggling to manage multiple devices, so find ways to integrate processes into single devices via apps on existing phones and tablets. Consider providing dedicated tech support or concierge services to help with issues.
Data integrity and privacy must be maintained in the electronic systems.
Follow online visit guides and protocols
Online visit guides and visit reminder systems are helpful for participants, especially if the technology can be incorporated into their existing phone/tablet.
Sites like the online protocols because they maintain the most recent versions of key study documents and can be flagged for specific content like I/E criteria.
Allow direct-to-participant shipping
Participants like the convenience of having flexible delivery windows and not having to drive to the site for investigational product and ancillaries.
Sites would like to maintain control of the process, with their pharmacy preparing the materials to ship and the site handing off the shipment directly to the courier to ensure oversight and quality.
Gathering direct feedback from sites was both enlightening and rewarding. Clinical trial sites are aware that DCT capabilities are becoming much more common. Because of this, sites’ primary ask is that we partner with them to help facilitate effective and flexible implementation.
These initial discussions helped provide a better understanding of specific concerns and needs and reinforced that Lilly will continue to grow and adapt as we continue to engage with sites moving forward. This feedback only solidifies our intent to ensure we have a robust strategy to provide the best experience to both participants and sites, as we happily and readily move to a post COVID-19 world.
Learn more from our first blog in this series which focused on how the COVID-19 pandemic changed how sites conduct clinical trials forever.