Are remote decentralised clinical trials the future?
In traditional clinical trials, patients must attend regular check-ins at hospitals or clinics but fully remote decentralised clinical trials (DCTs) and hybrid trials limit this by replacing the in-person meetings with virtual check-ins. The goal is to make trials more patient-centric and remove the barriers when recruiting and retaining patients whilst also improving patient experience. However, decentralised and hybrid clinical trials may not be the best choice for every study and to keep the patients’ needs at the core it’s important to involve them in the decision.
Due to regulations, remote DCTs have remained on the fringes but the outbreak of Covid-19 seems to have stirred it up; In the aftermath of Covid-19, 69.9% of interrupted clinical trials were held back due to issues enrolling patients. This had led some industry experts to argue that the current clinical trial model is not sustainable and it that’s the case, are remote DCTs the future?
The relationship between patients and treating physicians
In a remote DCT all or some of the in-person appointments are replaced with video calls which can be more convenient, saving the travelling time and making the study more accessible. Although this may boost enrolment rates, it’s argued that this comes at the cost of the important relationship between the patient and treating physician. However, in a remote DCT, the treating physician takes on a local support role which can enhance their engagement with the patient. The pandemic has proven what was becoming more apparent over time - that clinical trials must be adaptive for patients to continue with assessments and stay engaged.
Is it right for every patient?
Not all patients favour decentralised trials and many prefer a hybrid model where they still benefit from some face-to-face interaction with healthcare professionals. A study conducted by ICON found that 25-34-year-olds were most supportive of the remote aspects of these trials and as the age range increased confidence dropped. This is hardly surprising considering the level of digital skills needed to use technology devices in remote DCTs.
As time goes on more clinical trial patients will be from the younger generations who have been brought up using smartphones and are less likely to be put off using them in clinical research. This suggests that the shift towards remote decentralised trials will be more readily accepted in the coming years but for it to be successful, clinical research organisations must be patient with the changes and ensure that the process is not made more challenging for patients otherwise they risk impacting participation and dropout rates.
It may work better for some therapies than others
ICON’s survey also revealed that acceptance of decentralised trials differed between therapeutic areas, with patients in dermatology and neurology trials being most agreeable to the process and preferring the use of smartphones. By eliminating the need to travel to a location for check-ins, remote DCTs were also found to be particularly helpful for ongoing trials, such as those which span a few years looking at how a patient’s sleep is affected. Similarly, remote DCTs have been vital in the race to develop a coronavirus vaccine while clinical trial professionals and patients have been restricted from leaving their homes due to lockdown measures.
This is a clear reminder that although remote decentralised clinical trials may help to limit recruitment and retention barriers, it needs to be right for the patient.
Need access to technology devices
Offering eDiaries are a great way to collect information about symptoms and other essential data as and when they happen, and though there are associated costs with this process, this is in part offset with the reduced spending on travel. Though eDiaries revolutionised data collection, as our interaction with technology takes on a more complex form we’re seeing new DCT technologies fight for the spotlight, including extended reality (XR). Goldman Sachs projected that XR – which encompasses virtual, augmented and mixed reality - would raise a colossal $100 billion through sales by 2025.
These applications of technology are redefining the limits of clinical trials but as remote DCT is more readily adopted there’s a stronger focus on streamlining this technology. A core set of remote DCT technologies, including a platform that aggregates patient data and enables physicians to communicate with patients, are needed to ensure the trial runs smoothly. Meanwhile, the technologies – including wearables, XR and virtual assistants - must be connected so that patients can be monitored in real-time and to ensure that assessments and endpoints can be carried out.
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