Getting transformative, life-changing new treatments and medicines on the market as quickly as possible is the key priority for any biotech or pharmaceutical company.
There are many advancements and innovations that play a role in speeding up the entire drug discovery process, and the decentralisation of clinical trials could potentially become a key factor in this pursuit.
The implementation of decentralised clinical trials (DCTs) has been a growing topic in the sector for a good number of years now, with Pfizer having conducted the first ever virtual trial back in 2011, but they have now recently been pushed to the forefront of possibility following the COVID-19 pandemic – which raises a number of questions.
What are DCTs, and why do they suddenly seem like the next big thing? And of course, are they the future of clinical trials, or is this just a passing phase?
What are decentralised clinical trials?
The concept of decentralisation is nothing new, though you may be familiar with a different term for the approach,such as DCTs, virtual, home, remote or even siteless trials. Whatever term feels the most fitting, the key goal is the same: making clinical trials quicker and easier, for the benefit of both the participants and sponsors, so that new drug developments can hit the market faster. Getting new drugs to market quicker means more lives can be saved and more revenue for biotech companies who can capitalise on the opportunity to gain a larger market share.
Decentralised clinical trials utilise technology to conduct trials with minimal visits to a trial site, or even entirely remote. This includes digital tech such as using mobile applications to collect patient data without the need for in-person appointments, or even site visits from healthcare personnel.
It’s important to note that DCTs don’t equate to clinical trials being conducted without the presence of relevant healthcare professionals, nor does it mean totally eradicating patient/professional contact.
It’s about working towards a hybrid approach where technology, sponsors and CROs can work seamlessly alongside each other to offer an efficient, effective solution to the typical site-based, rigid systems. Essentially, decentralisation is a spectrum, and its main goal is to offer a patient-focused approach.
New guidance from the FDA advises companies undertaking decentralised clinical trials to be cautious of data variability and accuracy as patient information is collected from their homes or local healthcare facilities. However, the agency is enthusiastic about increasing the number of decentralised clinical studies as it can contribute to enhancing diversity in clinical research. The FDA also added that Greater adoption of DCTs will facilitate drug development in areas of medical need, which means more treatment options and better outcomes for patients.
The impact of the pandemic on DCTs
Up until this point, the mass adoption of decentralised clinical trials has seen little uptick, and it’s not exactly surprising. The entire drug discovery and development industry comes with a whole host of rules and regulations, so even the slightest change can feel like a major risk.
However, COVID-19 affected every single part of the industry in many ways, and the realm of clinical trials were by no means exempt from these changes. With restrictions and strict lockdowns all across the world, many research sites were forced to close and potential trial patients were required to stay at home, unless it was a COVID-related trial. As a result, DCTs really came into their own, with trial activities and the incorporation of decentralisation components in clinical trials now estimated to rise by 17% by the end of 2023, surpassing the peak activity observed in 2021.
Clearly, the pandemic was the catalyst – forcing what was once an idea into reality, pushing the boundaries of how drug developers could trial and test their new medical advancements. And although we’ve reached the other side of the pandemic now, it looks like DCTs are here to stay if the pharma industry wants to continue progressing at a rapid pace with drug developments.
Why decentralisation is the future of clinical trials
Accelerating patient recruitment
The most obvious benefit of decentralisation is the increased ease for patients. ‘Patient-centricity’ is a term that’s been floating around the industry for a good while now, which essentially means putting the patient first so they can experience the best processes and outcomes.
In a typical clinical trial, around 70% of potential participants live over two hours away from a trial site, and with many already juggling health conditions, full-time jobs, families and busy personal commitments, it can be difficult to find the time in the day to make the trip. After all, patients are real people, not just a piece of data.
Decentralised clinical trials that allow for fewer site visits, or even none at all, encourage faster patient recruitment with more patients willing to enrol. And perhaps more importantly, according to a survey 71% of respondents said that DCTs help accelerate patient recruitment, and 74% said they improved patient retention too.
Typically, approximately 30% of patients drop out of clinical trials, with participants struggling to stay enrolled due to health conditions and disabilities. However, if trials can be completed mostly from the comfort of the patients’ own home, this could change the game for retention rates – reducing the recruitment burden felt on CROs and sponsors as a result.
Increasing participant diversity
Following on from the previous point, the convenience brought on from DCTs also enables a wider, more diverse patient pool for trials. Rather than limiting potential participants to those within a reasonable distance of the trial site, you have the choice of people living in all kinds of geographic locations, people that are not typically represented in clinical trials.
Diversity is a critical factor when it comes to trialling new medicines. Ultimately, these are the people that will be using these new medications, so gathering various perspectives is absolutely fundamental for an effective test. Furthermore, a diverse patient group is incredibly beneficial for rare disease research, where those hosting clinical trials are often competing for the same limited participant pool with other drug development companies.
Improved reliability and accuracy of data
DCTs offer a new way of facilitating clinical trials, mostly through the implementation of innovative technology – which improves the reliability and accuracy of data and allows for a more standardised reporting system.
For example, DCTs can deploy ePRO (electronic patient reporting outcome) tools, which allow for real-time communication between patients and the study site personnel – essential for allowing trial participants to report symptoms and other data as and when they happen, minimising the incidence of unreported data.
This real-time communication and automation enabled by mobile app technology not only provides more accuracy in the data, but it also keeps patients more engaged with the trial itself. Without the need to travel to a site or call a medical professional to report any new insights, everything is simpler and it’s easier for participants to stay motivated.
Also, electronic records can be automatically tracked with times and dates and the data is kept secure and safe, compared to physical paper records that can easily be lost or inaccurately filled out.
Offers patients and DCTs a more streamlined experience
In a busy, ever-changing industry such as biotechnology, more specifically drug discovery and development which can often take over 10 years on average, any ways to quicken and streamline the experience will always be a welcome addition.
Research reveals that almost 80% of clinical trials fail to finish in time, predominantly due to the difficult sourcing and retaining participants. Decentralisation can limit those obstacles tenfold, quickening the process for the benefit of both sponsors and patients alike.
Though decentralised clinical trials offer a fantastic option for biotechs developing our next round of medical advancements, decentralisation doesn’t come without its issues. After all, new technological innovations are a great blessing, but can also be a curse.
For example, DCT participants may all need their own personal handheld mobile device to effectively communicate. This requires specialist technicians to implement this technology, train staff and patients on how to use this equipment and software, alongside fixing any issues and errors that may arise – all much harder to supply than the pen and paper of a traditional trial. And of course, all this adds extra time and expense to the entire process.
This may have an effect on data quality which is often a concern of sponsors when replacing accepted end points and protocols. How comfortable patients are with the technology can also impact data quality as some patients will be more adaptable to using equipment such as monitoring devices than others, which is why patient-centric clinical trial design also is critical to mitigate this issue.
Like most new advancements and innovations, decentralisation adds a certain level of complexity to the entire process, especially in its early stages. These complexities are mostly from a time, resource and funding perspective.
Sponsors must start to look for ways they can implement the vision of DCTs into their process, a way to support both patients and sites on their respective learning journeys.
Fully decentralised trials still remain a vision of the future, with only around 20% of conditions currently lending themselves to 100% decentralisation.