Covid-19, clinical trials, and the new normal
Introduction
Many new approaches to clinical research were pressed forward during the Covid-19 pandemic, most notably the move towards decentralisation. As the pandemic came to an end we finally entered a ‘new normal.’ We explore what looks like a short-term fix and what’s here to stay – Covid 19 and clinical trials and is there a new normal?
The "Covid-Effect"
To say that the Covid-19 pandemic had a negative impact on clinical trials would be an understatement. In 2020 and 2021, thousands of studies were stopped mid-trial due to local lockdowns and patient safety concerns. Planned trials were subject to long delays before they could safely start recruiting, while others were abandoned entirely. While the financial consequences for sponsors was clear, the disruption also created a backlog of unhappy patients waiting to receive tests and treatments.
Even the trials that did go ahead faced major problems when it came to clinical supply logistics. Certain governments banned exports in the early months, meanwhile shortages of critical medicines such as antivirals were commonplace. Moreover, slow enrolment and high dropout rates meant that many sponsors who had already secured their drug supply were suddenly faced with the issue of wastage.
The "Pharma Fightback"
In the face of all these problems, the clinical trial industry showed resilience and determination. Many sponsors found a way around the problems. Product wastage, for example, could be fixed by partnering with a pharmaceutical service provider like Abacus Medicine. We helped companies recoup potential losses by purchasing unused products for resale. We also helped many sponsors devise risk-mitigated approaches to comparator sourcing, using methods that maximise efficiency and minimise costs.
Meanwhile, many sponsors switched to remote trials, using remote technology to minimise the need for patients to attend trial centres and direct-to-patient shipments of drugs to find a way around the Covid restrictions. Regulatory bodies adapted their rules around this practice to facilitate the necessary transition. Although, as expected, the industry was met with a range of new challenges such as patient compliance, complicated logistics, and accidental protocol deviations.
Decentralisation
Despite the huge jump in decentralised trials (DCTs) in 2021, decentralisation didn’t come from nowhere. There has been a gradual increase in the number of decentralised trials since the mid-2000’s. The major driver of the trend has always been the motivation to improve patient recruitment, the age-old thorn in the industry’s side.
In fact, in a 2020 GlobalData survey titled ‘Addressing Clinical Trial Disruptions Related to the COVID-19 Outbreak’, 34% of respondents stated they were already using DCTs – including 41% from North America and 33% from Europe.
Respondents overwhelmingly noted that the shift towards DCTs was already planned before Covid-19, with the pandemic simply speeding up this timeline to the next one to two years. The highest-ranking perceived benefit of a postpandemic shift to DCT was ‘greater participation by patients in clinical trials.’
Are we in the ‘new normal’?
In 2022, successful vaccination programmes brought the Covid-19 pandemic under control in most parts of the world. Clinical trials ran smoothly again, free for the most part from the logistical havoc caused by Covid. But one thing seemed to stick around, and that was decentralised trials. In the first quarter of 2022, the industry commenced 284 decentralised trials.
This represented an increase of 2% from the number started in the first quarter of 2021 (278), and an 86% increase from the number commenced in Q1 2020 (153). This supports the general response of the GlobalData survey respondents back in 2020, suggesting the percentage of decentralised trials is set to continue rising in the next five years.
According to Ian Hoban, business development director at Abacus Medicine Clinical Trial Services, it is unlikely that we could ever live in a world where 100% of clinical trials are decentralised. “There’s an ongoing need to analyse the pros and cons of decentralisation since Covid raised its head, and decide which areas were useful in a crisis but not necessary in the future and which areas have really brought things forward. Companies don’t need to go for an all or nothing approach – as always, a hybrid approach will typically deliver the optimum outcomes,” he explains.
Conclusion
Post-Covid, the clinical trial industry has regained full power to choose how it wants to conduct studies in this new future. Some sponsors have more or less returned to the traditional model while still retaining a few elements of virtualisation. Others continue to embrace decentralised trials where and when it is possible to do so.
But despite the drop in Covid-19 hospitalisations, we still live in turbulent times.
A new, vaccine-resistant strain of the virus could send us back to square one at any point. Events like the war in Ukraine, which is currently causing major problems for trial sponsors operating in or sourcing products from Eastern Europe, show the industry’s need to always stay vigilant for the next unpredictable event.
Partnering with a reliable clinical trials solutions provider has never been so important. Abacus Medicine Clinical Trial Services sources thousands of specialist medicines from all over Europe, with access to real-time data and predictive insights concerning the availability, price, and documentation of different SKUs.
