Decentralisation of clinical trials has been a growing topic of discussion and development over the last few years, enabled further by the advancement of available technologies.
Here, we explore what we mean when we talk about decentralised trials and discuss why the clinical research industry has been reluctant to pursue this route. We illuminate the main benefits of decentralisation – demonstrating how these outweigh the concerns many organisations within the industry have expressed – and outline the key areas to consider when planning and designing a decentralised trial, or trial with decentralised elements.
What is a decentralised clinical trial?
There are different words to describe the concept of decentralised trials, including virtual, home, remote, and siteless. Whichever term your organisation may choose, the goal is the same: making clinical trials easier for patients by reducing or eliminating the need to travel to specific sites. This approach has been shown to reduce drop-out rates, increase study effectiveness, and ultimately get life-altering drugs to market faster – saving sponsors billions.
Decentralisation doesn’t mean conducting trials in the absence of healthcare professionals. Nor does it mean (in most cases) completely eliminating the need for any physical patient contact. Instead, it’s about looking at areas where technology and other novel solutions can enable sponsors and CROs to take a hybrid approach to clinical trial design, providing an alternative to a site-anchored, inflexible system which often results in a high patient drop out rate.
“Patient-centricity” has been an industry buzzword for many years. We understand that reducing the required time and cost it takes to participate in clinical trials eases the burden on participants and delivers higher retention rates and efficiency. In this way, decentralisation might be considered the epitome of a patient-focused approach to clinical trial design.
It’s important to note that decentralised trials exist on a spectrum. If introducing a fully decentralised model where patients never have to set foot in a clinical site isn’t possible, it doesn’t mean your studies can’t or won’t benefit from incorporating some virtual or at-home elements. For example, a number of site visits could be replaced by an HCP making a home visit, or with an app that facilitates data collection without needing patients to attend appointments.
As more clinical trials adopt decentralised elements successfully and technology advances even further, the number of home-based trials is going to increase – and along with this, so will participants’ expectations. It’s time to make sure you’re ready.
Why is the health industry reluctant to embrace decentralisation?
Up until now, the adoption of decentralised trials has been slow – and it’s easy to understand why. Healthcare is a highly regulated industry, which means professionals tend to be risk-averse and change at the top level can feel extremely difficult.
However, the COVID-19 pandemic has significantly shifted the landscape, at least for the short-term. If the pharmaceutical industry is to continue progressing with drug development, the traditional site-centric clinical trial model needs to evolve.
Encouragingly, regulators appear to support decentralisation. Sponsors will understandably want to receive clear guidance from regulatory bodies before progressing with developing new technologies and processes, as they need to be sure they can implement them.
Additional key challenges or barriers that sponsors may face are:
- Finding new technology vendors and approving them in a timely way so as not to delay trials
- Finding specially-trained couriers who are able to deliver medication and other medical supplies and equipment safely and legally
- Managing and processing a higher volume of patient data received via apps and wearables
- Continuity of patient care – inconsistency of visiting HCPs could potentially be distressing for elderly or neurodiverse patients, as well as those participating in trials related to serious diseases
- Time management – where HCPs are required to visit multiple patients in one day, they will need to travel between locations efficiently and on time while maintaining the high standard of care they would deliver on-site
- Technological failure resulting in a loss of patient data, as there will be no expert on hand to provide immediate guidance or fixes. This may disrupt or delay the trial progression by corrupting results.
- Patient attitude -- some patients may be more comfortable being seen in person, especially where they are unsure about administering tests or using technology. This may especially be the case for the elderly, or those participating in a trial for the first time.
While it’s important to be aware of these challenges, the benefits decentralised trials offer for patient recruitment and retention arguably outweigh potential risks which – with the right partners, vendors, and approach – can be sufficiently mitigated.
The main benefits of decentralised clinical trials
Decentralisation has the primary goal of making clinical trial participation as easy as possible, enabling participants to continue with their day-to-day lives with minimal disruption. Studies have revealed:
- 70% of patients live more than two hours from a research site
- In 50% of clinical trials, participants find it difficult to stay enrolled due to poor health
- 85% of trials fail to retain enough patients
Patients aren’t just statistics or data – they’re people. Many potential trial participants will be managing health conditions while running businesses, working full-time jobs, and raising families. Where this is the case, requiring patients to attend site visits, which involve hours of travel and accumulated costs, isn’t just difficult – it can be impossible.
In this way, the current clinical trial model prohibits participation from otherwise willing patients. This reduction in the available pool of participants not only has an impact on recruitment and retention, but it also impacts the integrity of the study by limiting diversity.
Fully decentralised or hybrid (a mix of site and home-based activities) clinical trials have huge potential to positively impact clinical trial development in numerous ways, including:
- Accelerating patient recruitment by making it easier to find potential participants (for example, in rural areas where travel to/from sites is difficult). More patients would be able and willing to take part if participation is easier, reducing the recruitment burden on CROs and sponsors.
- Increasing participant diversity by enabling patient recruitment from a much wider pool rather than limited to those within a reasonable distance of a participating site. This especially benefits rare disease research, where clinical trials are often “competing” for the same limited pool of participants.
- Patients become more knowledgeable, informed and engaged as a result of autonomy enabled by technology. There is a wide body of evidence suggesting engaged patients complete tasks such as electronic diaries with more accuracy and honesty. Electronic records can also be automatically time-stamped and verified as required.
- Gathering more diverse and applicable data sets by monitoring patients remotely in real-time. Furthermore, collecting data from a real-world setting is more likely to deliver insight free from the bias which results from undergoing assessments in a clinical setting.
- Improved reliability and accuracy of data – whilst paper can be lost or damaged or forms can be inaccurately filled out, collecting data using technology such as wearables, apps, and smartphones keep data organised and safe.
- Easier reporting and analysis of results as technologies enable data collection and sharing to be standardised
Key considerations for a successful decentralised trial
If you are decentralising elements of a clinical trial that would otherwise have taken place on-site, first look independently at each stage of the trial and identify which elements could be replaced by virtual or home solutions.
A cost-benefit analysis will also be required, to be sure that investment in alternative solutions will be beneficial in the long term. Some key points for consideration at this stage are:
- Will decentralisation of these elements significantly reduce the burden on patients, and therefore improve retention and reduce the trial’s overall cost?
- Will reducing site visits accelerate timelines by allowing us to gather data faster?
- Will changes to processes reduce workload for clinical trial sites, resulting in time and cost efficiencies?
The most common areas for consideration when designing decentralised trials are:
- Communication with patients: Where can use of smartphones and tablets improve and enhance patient communication and better facilitate data sharing?
- Travel reduction or elimination: Even if some patient travel is essential, are there any site visits that can be eliminated in order to reduce the burden on patients?
- Technology-enabled data collection: Where can wearable technology or patients’ existing devices be used to collect real-world data in real-time? Would this have the added benefit of eliminating transcription errors, or enhancing security?
- Home healthcare: Would having a fully qualified HCP visiting patients in their homes to administer medication, perform tests, or obtain samples allow the trial to progress without a site visit?
- Transportation of medications, ancillaries and samples: Could a specially-trained courier transport medication, ancillary supplies or samples (including those requiring temperature control), collect unused medications, and deliver new medications?
When it comes to considering the trial as a whole, there are three core tenets to abide by:
- Accessibility – use technology that’s easy to use and intuitive to learn. Technology is most effective in clinical trials when it fits seamlessly into patients’ daily routines and is accessible on devices they already have and are familiar with.
- Simplicity – keep tasks for patients as simple as possible. If what’s required of them is too complex, this not only causes stress but it can also impact the integrity of results as there is more chance of error.
- Reliability – make sure your tools and processes have been thoroughly tested and that you’re aware of any potential pitfalls requiring mitigation. As the trial progresses, use patient feedback to continually improve your processes and increase reliability.
While the coronavirus pandemic may have forced the clinical research industry to evolve more rapidly in the space of a few short months than it has in the past few decades, the industry was ripe for this change.
A new approach to clinical research is certainly needed. Increased decentralisation of trial elements is just one way – albeit a hugely important one – that needs of patients can not only be put first within the clinical trial journey but used to shape its processes and policies.
With great challenges come new opportunities, and we’re ready to embrace them with you.
Since mdgroup was launched in 2002, we’ve been on a mission to revolutionise the way the life sciences industry approaches product development. We combine global clinical trial and home nursing expertise with cutting edge technologies to provide a complete clinical trial patient support solution, significantly reducing the burden of site participation.
We remain agile and adaptable to the changing circumstances and we’re here to help you protect your patients and their families in any way we can.