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).
“Clinical trials are an orchestra with the patient at the center” -Study Coordinator in Brazil
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 at Lilly spoke to 26 sites from the US, Puerto Rico, Canada, Brazil, Spain, Italy, Germany, Turkey, the Ukraine, the Czech Republic, and Israel.
Employment of Decentralized Clinical Trial Capabilities
Reasearch showed that sites implemented many Decentralized Clinical Trial (DCT) capabilities out of necessity, with their primary focus on maintaining participant care.
Decentralized clinical trials (DCT) are usually described as studies that are executed through telemedicine and mobile/local healthcare providers, or in even simpler terms, a study that uses processes and technologies differing from the traditional clinical trial model.
Around the world we found that sites delivered creative and flexible solutions to ensure that their study participants maintained a high level of care and safety, while also maintaining a focus on quality and privacy. A central theme that spanned all of the sites was the desire to allow and adapt as participants chose their own paths with their continued participation.
Here are several examples of sites going above and beyond for their study participants:
- A site in Brazil sent personal drivers to pick up participants for visits or used the personal drivers to bring mobile nurses and supplies to the participants’ homes.
- A site in Spain used a hospital at home service to support clinical trial visits as well as provide care to general hospital patients.
- Sites recognized that many patients preferred in-site visits, so they rapidly changed their SOPs and clinic set-up to minimize patient-to-patient interactions while maximizing patient-to-HCP interactions. In order to maintain this on-site care, several HCPs had to sacrifice significant portions of their home and family life.
- In the US, a site rotated their on-site work staff so that they could ensure that someone was always quarantined and could work on-site if there was an outbreak with the other site staff.
- Lastly, a site in the US created a drop-off/pick-up system for study drug and necessary clinical trial supplies in their parking lot to make sure participants didn’t have to leave their car, while another site had their site staff deliver supplies to participants’ homes.
Continued Focus on Meeting Participant Needs in Innovative Ways
Necessity is the mother of invention, and the clinical trial site staff we spoke with displayed their focus on continuity of care for their participants by inventing creative ways to meet various needs during the global pandemic.
Joining a clinical trial is a very personal decision that involves time and commitments from participants. On the other hand, it also involves a focused commitment from site staff, to ensure both the emotional and physical needs of participants are met during the pandemic. To deliver quality, site staff were at the forefront of developing creative solutions to unique situations. The lessons that the past year brought to light will carry over, well past the pandemic, to help develop a new wave of clinical trials with flexible DCT capabilities at the core.
Stay tuned for the second blog in this series which will focus on the future implementation of DCTs based on site experience with various DCT capabilities.