Decentralised, virtual, home, remote… this type of trial has many names. But as complicated as the naming process has become, it’s a pretty simple concept. A decentralised trial is a clinical trial that allows patients to enrol and participate without visiting a clinical site.
Patient recruitment and retention is one of the biggest challenges for CROs and sponsors of clinical trials. 85% of trials fail to recruit enough patients, 80% are delayed due to recruitment problems and dropout rates remain high.
These days patients are more informed, more aware and ask more questions. They demand trials that are easy to participate in.
This has forced trial conductors to listen-up, with patient-centric trials now providing part of the answer. These trials are designed around the patient’s needs, comfort and convenience - making them more popular for patients and better for recruitment.
Examining approximately 4,000 phase II and phase III trials, a recent study found patient-centric trials take an average of four months to recruit 100 participants, compared to the seven months other trials take.
They’re not perfect though. Many patient-centric trials require their patients to report to a clinical site at some point. This can be tricky for those that have poor mobility or live in remote locations.
That’s why decentralised trials are the future.
Decentralised trials allow patients to take part in trials from the comfort of their home, with the convenient support of a visiting nurse/physician to help log their results. These trials are the ultimate patient-centric solution, meaning that they can provide even better recruitment results.
Thanks to advances in technology, we’re about to undergo a huge shift towards decentralised trials. Wearables, tele-health visits, online patient diaries, eConsent, video dosing confirmation and patient apps will all be a part of this revolution.
The technology used in decentralised trials collects data in real time and analyses it in real time too. This will help improve efficiency in trials and lead to more accurate results.
This new shift to decentralized trials will also help to reduce the burden on research sites and CROs whose resources are stretched.
There are multiple pioneers who’re paving the way for larger organizations to get involved in decentralized trials, whether organically or via M&As.
Science 37 are arguably frontrunners in combining innovation clinical data technology and the overall patient experience/execution. However, Spencer Health, Symphony Clinical, DP Clinical, Illingworth Research Group, Medable and Firma Clinical are all worthy of a mention.
Innovation in the clinical space has been needed for a while and decentralized trials are the future of clinical trial execution."
Darcy Forman, VP Clinical Operations of Science 37
Janssen and PRA have designed the first completely decentralized, mobile, indication-seeking clinical trial. They aim to assess the effectiveness of INVOKANA (canagliflozin) in adults with heart failure.
While the benefits of decentralised trials are clear and many companies are ready to reap the rewards, there’s still work to be done.
Continuity of care is a big concern. Decentralized trials would see patients introduced to an entirely different physicians and support teams throughout the process, that they aren’t familiar or comfortable with. This can be especially distressing for patients in trials related to serious, rare or cancerous diseases.
Time can be an issue too. A nurse/physician will have numerous patients to see on any one day, meaning their time is limited and the ability to develop strong relationships with their patients is reduced.
There’s also a big question surrounding “what if a device fails?”. Should this happen, there’s a chance that the patient won’t be able to rectify the situation and there’ll be no expert on hand to resolve the issue. This could disrupt the trial and corrupt results.
Despite these issues, the recruitment benefits of decentralised trials mean that they are the way forward. This move is likely to spark some resistance from the many research sites that host clinical trials, however, looking at the bigger picture, a higher compliance rate should offset this.
Decentralised trials are the future. They can help innovate an industry that’s rife with stagnation. With billions of dollars invested in the pharma industry and the higher volume and success rates suggested by decentralised trails, healthcare could look very different, pretty soon. And who says that the future of medicine needs to be in the form of pills, tablets or injectables? Decentralised trials could be the gateway to early intervention and preventive medicine.
Innovative companies are trying to make a real difference for patients with rare diseases and address one of healthcare's largest unmet needs.