The Covid-19 pandemic caused massive disruptions amongst clinicians, patients and communities. Labs, hospitals and clinical sites shut overnight, and research teams worked endlessly for months to discover potential vaccine candidates to bring to market as soon as possible. Although there is still a lot of flux in the world of clinical research in this post pandemic world, one thing is certain: the changes forced upon the pharmaceutical sector in response to the pandemic have opened many new possibilities for reimagining the way the industry operates in the future.
The new age of virtual clinical trials
When the WHO first announced that COVID-19 was a pandemic, governments all over the world took drastic steps to keep people from catching the disease, starting with lockdowns, travel restrictions and social distancing measures. Whilst this limited the spread of the virus, it also completely upended the traditional model of clinical trials, with patients coming into clinical sites for their regular visits suddenly becoming a major safety concern.
The pandemic emphasised that the tools and technologies the industry traditionally relied on for clinical trials were simply not fit for purpose in a digital-first world. New technologies and digital tools have been around for years, but the systematic adoption has been slow. In a report surveying senior leaders in the life sciences industry, many were amazed that the sector managed to develop, test and approve so many vaccines in such a short time. 70% of companies admitted that the processes they relied on at the start of the pandemic were outdated, and this was preventing them from working remotely and collaboratively. More challenging still, 62% struggled to even access valuable COVID-19 research due to these outdated processes. As a result, 84% of life sciences companies in the UK have accelerated their adoption of digital tools for clinical trials as a direct response to the pandemic.
Driving adoption of virtual trials
In response to the pandemic and global lockdowns the industry rapidly and universally pivoted to embrace virtual, or decentralised, clinical trials with the support of digital tools. This shifted traditionally site-based tasks into the safety and, ultimately, convenience, of patients’ own home – conducting visits via telemedicine solutions, capturing key endpoint data with tools like eCOA (electronic clinical outcome assessments) on smartphones, and engaging with patients remotely. This foundational shift supported the development of vaccines against COVID-19 in record timeframes to treat millions of patients across the globe. The Moderna vaccine trial, for example, is one of the largest trials to incorporate data capture directly from participants using their own smartphones, simplifying participation and decreasing the need for site visits.
By adopting this decentralised approach to clinical trials, the life sciences sector has shown that it can operate at a much faster rate, whilst also reducing margins for errors and improving the testing process for both researchers and patients. This also effectively solves one of the biggest challenges in the pharmaceutical industry – patient recruitment and retention. Research teams are virtually able to reach patients across the world and, more importantly, patients tend to have a better experience in the trial. As a result, companies have been implementing more digital tools in the hopes of getting new drugs and treatments to patients faster.
Virtual trials are the future
As improving patient outcomes still remains the number one priority within life sciences, having the right tools is essential. This is why 72% of companies have implemented digital tools, to support the conduct of virtual trials, to help them innovate during the COVID-19 pandemic.
Using digital tools in the clinical trial process provides many benefits for healthcare companies:
- Accelerating information sharing and increased controls: As all the data lives in a centralised and secure digital platform, it is much easier to share it with relevant stakeholders, whilst managing authorisations and ensuring patient privacy at all times. This can drastically minimise delays and any data anomalies can quickly be identified and rectified.
- Simplifying the R&D process: As R&D teams had to reprioritise new research in response to COVID-19, they needed to quickly pivot their internal working processes. By operating in a digital environment, labs reduce the risk of human errors and time spent correcting them – making them the optimum working environment in response to a global crisis.
Beyond the immediate impact embracing digital tools has universally had on clinical research, there are even greater revolutions on the horizon. Through the use of big data, artificial intelligence and digital simulation tools, researchers are beginning to build virtual models of organs to study and test on. For example, The Living Heart Project is already well underway to serve as a common technology base for education and training, medical device design, testing and clinical diagnosis. Additionally, tools like a Synthetic Control Arm®, where historic patient data is used to mimic a control arm in a clinical trial, minimizes the need to put patients on placebo.
In the future, the ambition of the industry is to run a clinical trial on an individual’s virtual twin – testing all kinds of doses and treatment combinations to identify exactly what will work best for a patient’s genetic profile without having to actually administer any drug to the individual themselves until the most effective solution has been identified.
Beyond the pandemic
COVID-19 has brought many challenges to the industry. More than two thirds of life sciences companies had to put research into other treatments on hold. However, as the vaccine rollout programme continues, the industry needs to start looking at life beyond COVID-19.
Since the pandemic, the life sciences sector has proven that it can adapt to a radical change in operations. There is now a greater need for improved collaboration across teams and organisations to speed up the entire clinical trial process. Luckily, the same tools used by the industry to tackle one of the biggest public health crises of the 21st century can also be used to devise treatments for lesser-known diseases.
Decentralised, virtual clinical trials can help aid drug discovery, the launch of new drugs and medical devices and provide the right kind of patient care in any environment. Using better data management tools can help healthcare companies become more diverse and adaptable, opening the clinical trial process to a wider pool of participants that are more representative of the patient population. As we look to the world post-COVID, it is time to start normalising the process of virtual clinical trials for any condition and creating a new era of preventative care for all.
And this is just the beginning – through the eventual use of virtual twins, research and development will reach a whole new horizon.
Article by Richard Coxon, Director, Life Sciences, Dassault Systèmes