Advancing a Phase IIb study in the midst of a pandemic

Conducting a two-country clinical trial involving two assays and a nasopharyngeal swab may seem straightforward. However, amid Brexit and a global pandemic, this study was far from simple.

Cerba Research was able to keep sample processing for a novel COVID-19 treatment on track in the middle of extraordinary upheaval through a combination of strong customer relationships, careful planning and creative logistics.

Phase IIb study

Image Credit: Lopatin

The case

Cerba Research needed to perform a controlled, randomized Phase IIb clinical trial for the evaluation of the efficacy and safety of the sponsor’s drug for high-risk subjects with mild COVID-19.

The study initially included 10 UK sites and 25 US. The subject population enrolled a total of 600 women and men aged 18 years and over who were recruited in the UK and the US. However, the sponsor moved to a decentralized model as COVID-19 continued to impact patients’ willingness to visit sites as well as site and investigator availability.

A “COVID in a Box” kit was delivered to patients’ homes once the sponsor randomized patients into the trial. Patients were then able to decide whether to participate remotely using telemedicine or on-site. Most chose telemedicine.

An agent from Marken, the preferred courier, arrived to collect the sample within an hour once the patient supplied the sample and repacked the box. A strict process using personal protective equipment (PPE) and physical distancing during the handoff was followed by both patient and agent.

The challenge

An ultra-quick turnaround time was needed by the sponsor. For example, a fully executed contract was requested one week after the award, and there was a three-month window to bring sites online and ship supplies.

Samples had a maximum room temperature stability of 72 hours between collection and testing, according to stability testing. This required samples to be transported quickly at a time when shipments coming through UK ports were at their peak due to Brexit concerns.

The response

The sponsor and Cerba Research had a strong preexisting relationship. This meant Cerba research was able to obtain approval and execute all contracts quickly, thanks to the high level of established trust.

Cerba Research’s central lab in Ghent, Belgium, was used to produce kits for the UK sites. The company’s New York facility was used to produce kits for the US sites. Kits were manually assembled using staff from other departments. Some staff worked weekends and evenings.

Teamwork ensued that each COVID in a Box was kitted out with the necessary PPE, requisition forms, and collection materials in as short a time as possible. Before kits were forwarded to the UK investigator sites in bulk, necessary random batch QC checks were performed.

An additional long-term stability experiment was done on the Abbott m2000sp sample preparation platform using the Seegene Allplex 2019 kit at Cerba Researhe’s lab in Johannesburg, South Africa, to address concerns about the short stability window.

Using this data, it became possible to extend the stability of the samples from 72 to 96 hours. Marken managed all inbound shipments. Stability issues were not the reason for any lost samples.

Top takeaways

All vendor and legal onboarding agreements should be in place early, perhaps even prospectively. Goodwill and responsiveness will help smooth the process even with necessary agreements in place.

It’s important to find practical solutions to sponsor challenges. Brexit-related logistical challenges were overcome in order to execute within a tight timeline thanks to Cerba Research experts in two different continents coming together to find solutions.

Central lab partners should be brought in early. Screening timelines, logistics, lab capacity, assay stability and other important aspects of the study can be evaluated during preliminary conversations. Research can be advanced sooner when strategies are developed in the early involvement.

Build a relationship of trust. Cerba Research has a reputation built on robust governance paired with open and transparent conversation and a commitment to doing whatever it takes to keep studies on time and on budget. This reputation allowed the company to get the rapid client buy-in required to deliver despite the challenging circumstances.

About Cerba Research

For over 35 years, Cerba Research has been setting the industry standard for exemplary clinical trial conduct. Today, across five continents, with a focus on precision medicine, we are changing the paradigm of the central lab’s role in complex clinical research.

From protocol inception through development and to market, our passionate experts deliver the highest quality specialized and personalized laboratory and diagnostic solutions. Partner with us for the most efficient strategy to actualize your biotech and pharmaceutical products sooner and improve the lives of patients worldwide.

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Last updated: Dec 23, 2021 at 11:35 AM


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