To improve your experience on Lilly TrialGuide, please use the latest version of Chrome, Firefox, Safari, or Internet Explorer, with JavaScript enabled.
This website is not optimized for your browser, as configured.
InnovationParticipation

The COVID-19 Pandemic Changed How Sites Conduct Clinical Trials Forever

TheCOVID-19PandemicChangedHowSitesConductClinicalTrialsForever FeatureImage 22July2021-01

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.

TheCOVID-19PandemicChangedHowSitesConductClinicalTrialsForever 22July2021-01

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.

Tags: Decentralized Trials, Clinical Researchers,

Recent Articles

TheCOVID-19PandemicChangedHowSitesConductClinicalTrialsForever FeatureImage 22July2021-01

The COVID-19 Pandemic Changed How Sites Conduct Clinical Trials Forever

Kevin Hudziak Photo
Kevin Hudziak
July 29th, 20213 minute read

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.

ThePathFromHCPtoResearcher FeatureImage 24Feb2021-01

The Path from HCP to Researcher: A Word of Advice

LTGBlogAuthors LillyGuestAuthorIcon 20July2018
Lilly Guest Author
April 21st, 20215 minute read

If you’re a physician interested in getting involved in clinical research, you must understand that it can be a big career shift. Luckily, Kamnesh Pradhan has valuable advice to share.

WeMustIncreaseDiversityInClinicalTrials FeatureImage 24Feb2021-01

Paving the Way to Better Diversity in Clinical Trials

LTGBlogAuthors LillyGuestAuthorIcon 20July2018
Lilly Guest Author
February 26th, 20218 minute read

To discuss what Lilly is doing to increase diversity in clinical trials, we spoke with two outstanding women who are leading the charge.

ResourcesToHelpAspiringClinicalResearchers FeatureImage 3Feb2021-01

Resources to Help Aspiring Clinical Researchers

Leigh Anne Naas Headshot
Leigh Anne Naas
February 10th, 20214 minute read

If you’re thinking about becoming a clinical researcher, it might be hard to know where to begin. We’ve outlined several resources to help you understand what to expect in a clinical research role.

StudyCoordinatorPatientPartnerThroughClinicalTrials FeatureImage 15Dec2020

Study Coordinator: Patient Partner Through Clinical Trials

LTGBlogAuthors GuestAuthorIcon 20July2018
Guest Author
January 13th, 20217 minute read

Study coordinators are a key part of the clinical trial journey. To learn more about what they do, read our interview with study coordinator, Kelly Roberts.