Turning to technology to future-proof clinical trials

THE global Covid-19 outbreak has disrupted not only manufacturing supply chains, such as in the pharmaceutical industry, but also clinical trial operations around the world, including in Singapore. One after another, we have seen pharmaceutical companies announce delays of their clinical trials, for instance Eli Lilly and Co, Bristol-Myers Squibb Co and Pfizer.

Traditional ways in which clinical trials are being conducted are being put to the test amid the pandemic, with repercussions for pharmaceutical companies and the wider industry.

Singapore has an active clinical trial landscape as well, so the country needs to prepare. According to the Health Sciences Authority (HSA), there were 465 ongoing clinical trials in Singapore in 2017, and in 2018, HSA approved another 130 trials.

Singapore's Ministry of Trade and Industry has also committed S$19 billion in its Research, Innovation and Enterprise (RIE) 2020 Plan to sustain research, innovation, and enterprise, between 2016 and 2020.

Around the world, healthcare institutions are turning to technology to help ease the burden on their systems. These include digital health offerings and telemedicine consultations between doctors and patients.

Technologies can equally be used for seamless clinical trials as well. Specifically, organisations running clinical trials in Singapore should consider technologies that allow for the remote gathering of patient data, maintaining drug supply, and managing systems through a centralised platform which will help companies manage trials more effectively.

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Traditionally, clinical research has been largely reliant on physical clinical trial sites, including hospitals, medical centres, and laboratories. This geographical restriction can pose challenges for researchers who may now face physical constraints on patient recruitment as well as patient engagement.

Go digital with clinical trials to reduce patient burden

In a city-nation such as Singapore where transport infrastructure is extensive and reliable, commuting to trial sites may not seem like an obstacle. However, clinical trials can be a burden on patients, including lost days from work for site visits, travel costs, and strain on patients and their caregivers to devote time and energy to participate. Therefore, although sponsors may be able to recruit participants, they may not be able to retain them throughout the duration of the trial.

Now with Covid-19, these challenges are magnified as people are pretty much self-isolating, and as healthcare and pharmaceutical resources are reallocated to help address the pandemic. Recent reports found that the novel coronavirus outbreak has started to disrupt the testing of experimental medicines as travel restrictions make it difficult for patients and staff to reach study sites.

Rapid and safe implementation of protocol amendments is vital to address both site closures and the fact that trial participants may no longer receive or have access to the investigational product. Inaccessible sites call for alternative remote approaches to drug supply, monitoring study conduct, compliance, patient safety and data quality. The more trials can be safely "virtualised", the more likely they will be able to successfully proceed.

To overcome these challenges, life science companies need to ensure their preparedness for unforeseen disruptions such as Covid-19. For example, clinical trials should be ready to be run remotely if needed, and data should be able to be accessed electronically to ensure research and business continuity.

Trials should be "virtualised" - meaning they are run by using technologies and digital tools that allow patients to remain at home. For example, using apps to track patient symptoms and leveraging video tools to allow doctors to "meet" with patients and immediately respond to their needs.

Having digital aspects to clinical trials during a health crisis also enables researchers to add new tools and features quickly to the patient applications to track relevant symptoms and provide information. For example, we launched a platform for patients in clinical trials to monitor and track their Covid-19 symptoms to collect data directly from research participants who may not otherwise be able to continue with traditional site visits. At the peak of the pandemic in March, clinical trials in China with remote monitoring were some of the only ones still ongoing in the country.

Regulatory guidance to promote the use of technology

Governments around the world are also realising the power of technology in clinical trials. While clinical trial disruptions - for studies not related to Covid-19 - may not be the most pressing concern at the moment, the need to address other medical issues does not stop here. For patients and for the life sciences industry, the trial disruptions and delays could develop into serious long-term problems if the model of conducting clinical trials is not transformed.

In these unprecedented times, regulators across the world have provided updated emergency guidance on conducting trials to ensure that studies can continue during the pandemic. For example, Singapore's HSA has suggested the use of technology in clinical trials such as remote study videos where possible.

What technology should Singapore clinical trials be using?

The impact of Covid-19 on trial success is already an issue, as evidenced by pharmaceutical companies citing the pandemic as a reason for study failures. These growing examples of trial delays or stoppage to mitigate the cost and impact of the pandemic dramatically highlight the need for rapid, innovative solutions to help trials successfully start, continue and finish. While technology usage is important, it's even more critical that organisations are implementing and using the right technology.

We've seen from our research that many clinical trial research organisations have tried to adapt by tweaking a platform here or adding a new app there, but this has only yielded a patchwork system of sites, spreadsheets and dashboards that further burden the process. On average, over 25 different solutions are used in a clinical trial workflow today, making data traceability, human subject oversight and timely payments a Herculean task.

While this might be manageable for smaller-scale research, many studies are taking place on a global scale, so there is a need to ensure that clinical processes are managed effectively and efficiently.

To futureproof their clinical trials, Singapore organisations running studies should look at implementing a unified data platform that can aggregate and integrate data allowing for seamless sharing across the clinical trial ecosystem, decrease the data entry and maintenance burden, and reduce design process complexities.

At the same time, having a single platform can allow simplification of complex processes and effective collaboration across teams. This could, for example, cut down inefficiencies in standardising data across multiple clinical sites and encourage the sharing of complete, timely, and high-quality data.

During such times when remote working is mandatory, and resources are strained or limited, a unified platform that promotes efficient practices is key to ensuring the viability of ongoing clinical trials.

In addition, to support industry recovery efforts during this time, data and analytics can be used to develop industry tracking, forecasting, and deep dives for priority studies to support Covid-19 impact assessment, risk mitigation, and recovery decisions.

Through this Circuit Breaker period, we can expect that clinical trial professionals will learn new skills on the latest in industry technology while they adapt to working from home. They will come out of these challenging times more tech-savvy and adept in new skills to apply in their daily roles.

Post Covid-19, this digital transformation could show promise as an investment into our preparedness for the future. Integrating technological infrastructure during this time sets the foundation to encourage the continued use of technology in trials, and in reconsidering the way we approach and future-proof clinical trials.