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COVID-19 Clinical Trials: Highlights From the Research Site Perspective

Since May 2020, Meridian has enrolled more than 10,000 patients into COVID-19 vaccine trials and supported 30+ SARS-CoV-2 research programs for vaccines, treatments, prophylaxes, and diagnostics.

Throughout the COVID-19 pandemic, Meridian relied on the infrastructure in place to help rapidly scale throughput at sites nationwide. While some aspects of the COVID-19 vaccine trial conduct required new processes, Meridian’s forward-looking investments and preparedness for yearly high-volume vaccine studies made it possible to scale operations without compromising quality.

COVID-19 study participants enrolled to-date

COVID-19 Research Milestones

January 2020

In January 2020, the U.S. sees its first case of the disease later named COVID-19 and declares a public health emergency. By March, the WHO declares COVID-19 a global pandemic. Travel bans and stay-at-home orders begin.

May 2020: Meridian Enrolls First COVID-19 Vaccine Study Patient

On the morning of May 29, 2020, Keith Vrbicky, MD, Meridian Principal Investigator in Norfolk, NE, enrolled the first participant into Moderna's Phase 2 COVID-19 vaccine trial for mRNA-1273.

Keith Vrbicky, MD
Keith Vrbicky, MD, Meridian Principal Investigator - Norfolk, NE

June 2020

As research programs progressed, Brandon Essink, MD, CPI, Medical Director at Meridian, and Paul Bradley, MD, Principal Investigator at Meridian in Savannah, GA, joined weekly meetings with vaccine developers participating in the Operation Warp Speed (OWS) program and collaborating with the National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA). These calls helped guide protocol design for multiple sponsors.

Meridian was the first site to gain IBC approval for a large Phase 3 COVID-19 vaccine trial, and the company’s eight sites were also among the first 15 to gain approval for the study, which involved almost 100 sites.

By the end of June 2020, Meridian had enrolled 500+ participants into Phase 2 COVID-19 vaccine trials.

Leaders of the Operation Warp Speed (OWS) program visit Meridian Clinical Research's internal medicine site in Savannah, GA

July 2020

Leaders of the OWS program visited Meridian’s internal medicine site in Savannah. Visitors included Dr. Moncef Slaoui, Chief Scientific Advisor of OWS, and General Gustave F. Perna, Chief Operating Officer of OWS.

July 2020: Meridian Enrolls First Phase 3 COVID-19 Vaccine Study Participant

On July 27, Dr. Bradley enrolled the world’s first participant into Moderna's Phase 3 trial for mRNA-1273. The participant, Dawn Baker, is a prominent news anchor and voice in Georgia.

On July 27, Dawn Baker, a prominent news anchor and African American voice in Georgia, becomes the world’s first participant in Moderna's Phase 3 trial for mRNA-1273.

June 2020

As Phase 3 trials progressed, several Meridian Primary Investigators and leadership team members were quoted by major news outlets. Dr. Shishir Khetan, Meridian Principal Investigator in Rockville, MD, is quoted in a Washington Post article about the challenges of conducting clinical research during a global pandemic and the misconceptions that circulate among the general public. Brandon Essink, MD, CPI, Medical Director at Meridian, is quoted by NBC News, and Dr. Asefa Mekonnen, Meridian Principal Investigator in Savannah, GA, is quoted by both ABC News and The Savannah Tribune, both doctors discussing the importance of diversity in clinical research.

July 2020

In October, officials from the U.S. Department of Health and Human Services (HHS) held a roundtable with Meridian leaders in Savannah to discuss the patient recruitment efforts and the research Meridian conducted for COVID-19 vaccine clinical trials nationwide.

Officials from the U.S. Department of Health and Human Services (HHS) visited with leaders from Meridian Clinical Research in Savannah, GA.

Brandon Essink, MD, CPI

Brandon Essink, MD, CPI, Meridian Principal Investigator and Medical Director, served as one of three co-lead principal investigators for Moderna’s Phase 3 COVID-19 vaccine trial for mRNA-1273, also served on the trial’s data and safety monitoring board (DSMB), and coauthored the trial’s primary publication in the New England Journal of Medicine.

Brandon Essink, MD, CPI

October 2020

As vaccine trials became the industry’s priority and entered the public spotlight, Meridian won the 2020 Vaccine Industry Excellence (ViE) awards for Best Clinical Trial Site and Best Clinical Trial Network (the latter as the largest member of Platinum Research Network).

ViE Vaccine Industry Excellence Award winner
Nicole (Nikki) Osborn

“Winning the ViE awards reaffirmed the quality of work our investigators and staff put forward every day, and the trust established with leading vaccine developers.”

Nicole Osborn Founder and CEO, Meridian

COVID-19 Study Participants Enrolled by November 2020

November 2020

In early November, Moderna completed enrollment of its Phase 3 trial for mRNA-1273, in which Meridian enrolled more than 2,750 participants, bringing the total number of COVID-19 clinical trial participants at Meridian to more than 3,500 by the end of November.

December 2020

The FDA issued Emergency Use Authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020. A week later, the FDA issued EUA for the use of the Moderna COVID-19 vaccine. Emergency Use Authorization (EUA) for the use of the Janssen COVID-19 vaccine is issued the following February of 2021.

Dr. Essink served as one of three co-lead principal investigators for Moderna’s Phase 3 COVID-19 vaccine trial for mRNA-1273. Dr. Essink also served on the trial’s data and safety monitoring board (DSMB), and would co-author the trial’s primary publication in the New England Journal of Medicine.

2021 & Beyond

By December of 2021, Meridian reaches 10,000 COVID-19 clinical trial randomizations and continues to enroll patients into COVID-19 trials, including studies for booster and variant vaccines, treatments and diagnostics. Thank you to the incredible people who have supported the vaccine studies, as well as COVID-19 medication, diagnostic, and observation studies at Meridian and beyond.

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Participants enrolled into COVID-19 clinical trials

COVID-19 Clinical Trial Recruitment and Retention

Call centers dedicated to recruiting, screening and scheduling
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Participant leads generated through in-house advertising and media outreach
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Participants enrolled into COVID-19 clinical trials

Advertising & Public Relations

Meridian directed recruitment advertising and public relations activities that generated more than 60,000 new, fully-identified potential participant leads in less than a year. More than half of the 10,000 patients Meridian has enrolled into COVID-19 trials were attained through in-house advertising and media outreach. Additional interested participants were reached through the NIH CoVPN Volunteer Screening Registry.

Participant Screening & Scheduling

Given the volume of interest, Meridian developed a unique screening process to triage qualified participants for particular studies. “We were able to enroll patients into trials that best supported Sponsors,” said Beau Garland, Vice President of Recruitment at Meridian. “For Phase 3 trials, we helped Sponsors achieve proportionate ethnic diversity and enroll patients with certain pre-existing conditions. We wanted to go beyond the minimum inclusion/exclusion criteria to find the right patients.”

Meridian partnered with StudyKik in June 2020 to screen the influx of potential participants interested in vaccine studies. In less than four months, StudyKik helped Meridian call and screen almost 22,000 potential participants who requested information about COVID-19 vaccine trials. At peak times, Meridian and StudyKik call centers processed a combined 2,000+ leads per week.

“Working with Meridian on this project was a phenomenal experience. We couldn’t have asked for a better partner to work with patients and make an impact on bringing a COVID-19 vaccine to the world,” said Sam Haiden, Chief Strategy Officer at StudyKik. “As always, their staff was responsive, attentive, and professional. Given the unique challenges that this pandemic has presented, both StudyKIK and Meridian had to rapidly solve new challenges to support these trials.”

“StudyKIK has been a valuable partner for Meridian since 2014,” said Osborn. “They were our first call when we needed to screen that volume of patients quickly and accurately — we knew they’d deliver a made-to-match solution.”

In October 2020, Meridian opened a new call center and dedicated research center in Sioux City, IA. This call center, along with Meridian’s fully-owned and -operated call centers in Omaha, NE, and Statesboro, GA, supported screening, scheduling, and follow-up activities.

Meridian also developed a novel retention program to support several COVID-19 vaccine studies. The program provided participants with a unique item at each in-person visit. Additionally, Meridian hired specialized call center staff focused on patient retention and engagement to ensure trial completion and full adherence with diary, visit, and safety calls.

Infrastructure and Clinical Operations

of Meridian's 30 research sites conducted COVID-19 clinical trials
average turnaround time (days) for IBC approvals

Meridian has conducted COVID-19 clinical trials at ten sites nationwide. To accommodate high-volume trials and spikes in COVID-19 vaccine trial interest, Meridian introduced a traveling vaccine team, increased staffing, and extended office hours to see patients seven days a week at all high volume sites.

Where possible, Meridian expanded into secondary clinical spaces to accommodate sick visits. Where space was constrained, sites improvised. “We used electronic buzzers like you find in restaurants,” said Laura Falcone, COO of Meridian. “This was helpful for queuing patients — we could check them in while they stayed in our parking lots.”

All Meridian sites used call-in parking lot waiting and extended scheduling to moderate site traffic and allow for intensive cleaning between visits.

Meridian more than doubled its clinical and operational staff companywide in 2020. All new clinical staff underwent a comprehensive training program that included compliance (e.g., ICH-GCP, TransCelerate, IATA, OSHA) and Meridian-specific courses.

Compliance, Quality Assurance, and Audit Support

In 2019, Meridian made significant investments to centralize regulatory processes on a web-based platform. That move expedited Sponsor, CRO, and PI review, and enabled immediate, secure access for remote monitoring companywide. “In years prior, we also ensured sites had HD videoconferencing capabilities, and we had been honing processes to cut data entry timelines to within an hour or two of patient visits to give Sponsors and CROs data in near real-time,” said Osborn. “In a world suddenly dependent on virtual workflows we had the tools in place to scale up immediately for high-volume COVID-19 trials.

As a leading enroller for the Moderna, Pfizer/BioNTech, and Novavax trials, Meridian’s dedicated quality assurance staff cut data entry timelines to within two hours of patient visits, enabling Sponsors/CROs to receive data in near real-time (the industry standard for data entry is typically 48-72 hours post visit). All sites also supported remote monitoring visits.

To support trials involving genetically engineered vaccines, Meridian partnered with Advarra to streamline Institutional Biosafety Committee (IBC) review and oversight. Eight Meridian sites operated with harmonized standard operating procedures (SOPs), which resulted in an average four-day turnaround time for approvals. Meridian was the first site to gain IBC approval for a large Phase 3 COVID-19 vaccine trial, and the company’s eight sites were also among the first 15 to gain approval for the study, which involved almost 100 sites.

Andrew Kimball

Connect with Andrew Kimball, VP, Business Development at Meridian

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