Delivering safe and effective clinical trials during the COVID-19 pandemic

The COVID-19 pandemic has posed a mammoth challenge to clinical trial units. Due to the nature of the work, they have faced significant disruption to the day-to-day business of clinical research. The objective has been to re-commence activity in a safe and coordinated way that goes above and beyond government guidance for workplaces.

Pharmaceutical companies have faced similar challenges. Keeping therapy and vaccine development programmes operating has forced creative and ambitious minds to act quickly. Some organisations have moved faster and more effectively than others, and – from the conversations I have had with sponsors and peers – I am glad to count Richmond Pharmacology among them. We have not only been operating trials at our London Bridge facility for some time now, but we are also actively and safely recruiting patients. Furthermore, we have used our testing technology and frameworks to provide reassurance to staff at a local primary school.

Now is a time for shared learning. The changes we introduce will be the first iteration of a new operating model for our industry. I hope to spark a discussion about planning for this new model, by sharing examples, lessons learned and encouraging others in the field to share their own experiences.

The measures we have introduced can be summarised in four stages. First, we imposed strict entry control for the building, evaluating key indicators such as symptom scores, body temperature, travel history and contact tracing for anyone entering our facility. Secondly, we used antibody testing to establish whether there had already been mild infections; none were detected. Due to the rising infection rates across the UK, we made mask-wearing mandatory.

When PCR test kits finally became available, we introduced a comprehensive testing programme for all staff, their families and visitors to our facility. Among our 180-strong workforce, we were able to identify those who were PCR-positive and intervene early. While some members of staff tested positive, we were glad that no patient volunteers did, and have not since. Many of our participants have felt reassured to receive the tests and are pleased to see that Richmond Pharmacology are making provisions keeping them safe.

We then implemented a suite of protocols to mitigate the spread of the disease. These included the distancing of beds and workspaces, a staggered pattern of shifts for employees and effective remote working where possible – particularly for non-clinical staff. Staff and visitors were required to wear protective equipment and use disinfectants frequently. Although some of our measures were required by guidance, we went much further while closely monitoring the efficacy of these measures.

We also undertook an assessment of the working practices of our staff and made strategic decisions to focus trial activities on essential tasks. Anticipating a long duration of the pandemic, we now focus on process improvements allowing us to test more patients without adding to staff workloads. This allows us to progress as many studies as possible, without compromising the safety or quality of trials.

We continue to monitor the prevalence of the virus closely. Our testing capacity has evolved over time, but we now carry out the most advanced rapid point of care PCR testing for staff, their families and patient volunteers, providing results in approximately 20 minutes. This ensures that we do not miss asymptomatic infections. We have implemented accurate antibody testing (RAPG-COV-019) that indicates whether someone has had COVID-19 and is potentially immune.

With these measures still in place, our clinical capacity is, of course, reduced. We are in close contact with trial sponsors to manage timelines while working further to optimise our processes. Trial participants will continue to travel to our site as normal, but we are minimising COVID-19 exposure during travel by using black cabs with a separate passenger cabin or asking patients to drive themselves. PPE is provided for those who must travel by public transport.

It’s clear that COVID-19 will have many longstanding consequences. The ABPI has, for example, outlined some innovative ways that contract research organisations are adapting trials to the current circumstances. There will be greater scrutiny on staff and patient safety and public health measures to protect our communities; this has been seen in recent surveys of clinical researchers, with institutional review boards and ethics committees seeing concerns to this effect.

I look forward to the debate on which of these new ways of working can be adopted long-term, ensuring that UK clinical research remains at the forefront of global life sciences in the new environment shaped by the seismic impact of the pandemic.

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