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KEY FINDINGS
As previously mentioned, DCTs can help overcome many barriers to research involvement. However, our experience shows that the needs and preferences of patients and caregivers must be carefully considered on a study-by-study basis. The disease in question and the daily challenges it brings have a huge impact on the individual home-based strategy that is to be deployed. That said, quantitative research results showed little difference between respondent groups in terms of preferences of DCT options, with home medication deliveries (42%), phone apps (40%) and wearables (40%) being the most interesting options, though a similar proportion also preferred in-hospital involvement (40%):
Many haven’t told their extended family; they haven’t told the wider community. So if they were taking part in a decentralized clinical trial, that could expose them. Many don’t want healthcare professionals coming to their houses because then neighbors will know something is wrong.
Trishna Bharadia, Patient Advisory Council Member
DCTs should be approached with flexibility and an understanding of the needs of different communities.
This will ensure that the benefit of reduced patient and caregiver burden is not in conflict with their needs. An adaptive, flexible approach can facilitate patients being seen in locations nearby, such as hotels, rather than in the home, in order to maintain privacy and still make research more accessible.
Also discussed was the lack of access to WiFi or a good data plan for some participants, which could create a challenge for study-based patient apps and telehealth visits. This can be overcome by the sponsor provisioning devices and data plans, which should be incorporated into the planning stage of a study, based on upfront conversations with patients and site staff. The pandemic has shown that such an approach can be highly beneficial to patient oversight and engagement, with one physician stating:
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