The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic
Liu et al.
The finding, in our words
The authors implemented a fully remote outpatient trial of hydroxychloroquine prophylaxis in 54 household COVID-19 contacts using self-collected saliva for SARS-CoV-2 RNA PCR testing and a smartphone-based six-lead ECG system for remote cardiac monitoring, with 42 participants completing the study and no serious treatment-related adverse events. The trial numbers were too small to assess prophylactic efficacy, but the experience demonstrates that decentralised enrolment, home diagnostic sampling and remote monitoring can be rapidly deployed in a community health system, while noting that lack of internet access excluded some potential participants.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
In a Phase 1 crossover study of etrasimod, self-collected blood microsamples yielded pharmacokinetic exposures comparable to conventional venous sampling, both with and without participant practice sessions. Continuous wearable sensors concurrently enabled real-time remote monitoring of safety vital signs and electrocardiograms, demonstrating the viability of hybrid decentralised designs in early-phase clinical trials.
Malhotra et al., Clinical pharmacology and therapeutics · source ↗
In this decentralised n-of-1 crossover trial of dapagliflozin in 20 adults with type 2 diabetes, remote collection of urine and capillary blood samples achieved 99.4% and 98.4% delivery success respectively, demonstrating that remote monitoring can reliably track individual albuminuria responses to therapy.
In a decentralised phase 1 trial, healthy adults used a clinical trial app to self-collect blood microsamples and vital signs at home, with 65 to 70 per cent successfully providing blood samples and most preferring self-collection over staff collection.
Ye et al., Contemporary clinical trials communications · source ↗
Decentralised monitoring of people with type 2 diabetes using continuous glucose monitoring and a hybrid smartwatch was feasible, with high participant retention and successful collection of glucose, heart rate, activity, sleep and GPS data via a study app.
Ali et al., Journal of diabetes science and technology (paywalled) · source ↗
AI analysis of salivary crystallisation patterns from self-collected saliva predicted delivery dates with high accuracy in a small cohort, offering a virtually painless home monitoring option for pregnant women that could support decentralised antenatal care.
Li et al., IEEE journal of biomedical and health informatics (paywalled) · source ↗