The first recognised modern clinical trial was conducted by James Lind in 1747.
It saw sailors, suffering with scurvy, have their diets supplemented with some weird and wonderful additions to discover what effect they had. Among other things, sulphuric acid, seawater, cider and fruit were used which meant that some of the sailors got a much better deal than others! Even though the fruit quickly ran out (they were at sea at the time), the citrus-and-cider imbued groups were the only ones to show any change in their condition. And thus, ‘clinical’ trials were born.
In the intervening 274 years we’ve come a very long way. However, it’s unlikely that there has been a more rapid, concentrated evolution of clinical trial processes in all that time as in the last 18 months.
Every industry ground to a halt in March 2020 as COVID-19 swept the world. While some sectors were forced to shut down completely, clinical trial providers couldn’t simply stop. That would have meant years of research and funding gone to waste.
There was also the need to rapidly discover, test and manufacture treatments and vaccines for this new disease. Those factors accelerated what was an already burgeoning call for the embrace, adoption and mastery of the technology, already available to us, that’s needed to successfully conduct decentralised clinical trials (DCTs).
For this article, I’ve used the broad term of ‘eClinical’. It’s a term that’s been around for decades and one that has been interpreted differently depending on which stakeholder group you belong to. Here, to be clear, I’m using it to group together the different technologies, platforms and systems of the clinical trial and DCT ecosystem.
I’ve then broken these eClinical offerings down further for ease of addressing each part individually. Whilst there is always overlap, those sectors are:
Now, as we take a look at each one individually, it will become apparent why they have become so integral to the clinical/decentralised trial process in the last 18 months.
Who’s involved? Trialbee, ClinOne and Illingworth Research (now Syneos Health).
Companies in this space have created technology, systems and platforms designed to find, match, enrol and engage motivated clinical trial participants, fast.
These businesses are able to harness and tap into huge, international patient networks and real-world data (RWD) to match up participants with relevant studies and support another trend - diversification of patient recruitment. They then provide platforms to contact and manage the patients until they are officially enrolled in a trial.
These platforms go as far as to help patients access reimbursement for travel expenses, booking accommodation and accessing remote nursing – all things that can contribute to a higher dropout rate among trial participants.
The dropout rate is further reduced as the easy-to-use platforms regularly communicate and feedback information to patients reminding them to attend visits. Some platforms even provide directions!
Who’s involved? Castor, AnjuSoftware, 4G Clinical and CALYX
These ‘traditional’ technologies have been around for a while with EDC systems being largely adopted in the late 90s, as a result of the internet, and are applied in hundreds of thousands of trials all over the world, regardless of the therapeutic. They serve a variety of purposes including document management and patient communications.
At their heart, companies in this broad category also deal with facilitating the access to and integration of clinical trial data. That means capturing information from clinicians, patients, devices, wearables and other electronic health record (EHR) systems.
They also facilitate randomisation and trial supply management solutions (RTSM), helping with the logistical management of trials. This can be a hugely complex operation, but solutions like 4G clinical’s have made this process far more seamless; they can create systems automatically, based purely on written RTSM specifications.
Who’s involved? Spencer Health Solutions and VirTrial (now Signant Health)
Telehealth and telemedicine tools and platforms are designed to give patients direct access to healthcare or treatment remotely. In context, this means patients can participate in trials seamlessly without having to leave their homes.
Spencer Health Solutions’ device, Spencer, can dispense treatments to patients at the correct time and in the correct dosage whilst collecting qualitative feedback using an interactive touch screen.
VirTrial allows for remote trial visits. According to VirTrial’s own statistics, while 87% of patients want to be involved in clinical trials, 70% of patients live more than two hours away from their nearest study centre and there is a 30% drop out rate from standard trials. Their method sees the drop-out rate reduce to 5% and the geographical constraints removed.
Whilst some telemedicine providers advocate for totally remote, with decentralised trials, VirTrial aren’t. Instead, they’re championing a hybrid model where some (25-40%) site visits are replaced with virtual video visits for optimal results.
Who’s involved? Cytel and ERT.
As more data is collated throughout the clinical trial process, these are the companies that provide statistical software and analytics for clinical trial design and execution. They can help with data integrity, providing and creating a statistical analysis. The computing muscles these companies are able to flex also helps to gain value from previously unusable, small or skewed data sets.
Their technologies can also provide platforms for patient diaries and ensure data quality throughout the process, meaning faster, easier and more efficient analyses is recorded.
As these companies conduct and analyse more trials, they are also becoming more adept at anticipating the results with predictive analytics. This is already having an impact, as fewer trials fail approval processes or get rejected by regulatory bodies.
Who’s involved: Science 37, Medable and THREAD Research.
Like Clinical trial technology services, decentralised trial platforms have been around for a few years, however they saw a huge spike in usage in early 2020. For almost six months of last year, decentralised trial platforms were the only viable way to conduct a clinical trial.
When it comes to functionality, these platforms can encompass many of the technology sets I’ve already mentioned. Or, they can be the technology that pulls all of the other components together into a comprehensive decentralised trial format.
It’s thanks to these technologies that companies were able to complete trials and develop a vaccine so quickly. In the words of Medable CEO Dr Michelle Longmire:
“We know now that when patients are able to access a clinical trial online, using telemedicine and remote consent, most clinical trials will enrol three times faster. That’s an incredible data point that we didn’t know before COVID-19.”
More than most industries, the eClinical sector has been thrust into the spotlight and tested over the last 18 months and, from the conversations that I’ve had with many in the space, has passed with flying colours.
Ultimately these technologies and platforms will only become more critical to the trials of the future. But whilst they all point in the direction of DCTs its important to remember that DCTs are not the holy grail, as with anything in life there will be resistance, meaning hybrid clinical trials will also be an integral part of the future of clinical research.
As John Reites, CEO of THREAD Research described back in 2018, “this is a journey not a destination that we drive to tomorrow”... “I think that every healthcare leader today sees that the technology landscape is helping us to move healthcare to more remote and virtual models.”
And John was right in 2018, many more healthcare leaders are seeing the benefits, none more so than Craig Lipset who has championed DCTs for years and who recently founded the Decentralised Clinical Trial Alliance (DTRA) which is bringing unity to the industry like never before.
So the question is, with the speed at which COVID-19 has been combatted using tech, why would we ever go back?
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