IN PARTNERSHIP
adherence increased their medication adherence from 85 ± 16% to 96 ± 6% (P<0.01). “At a time when digital health technologies are being pressed to provide more evidence(5)
,
our study shows that Huma’s DCT platform enables engaging and patient-centric research,” “Medication adherence is a major challenge in cardiovascular care so it is highly encouraging to see improvements, particularly for patients with poor baseline compliance, which will ultimately impact their prognosis. “We are evaluating similar responses in the work we are doing in other therapeutic areas such as respiratory, musculoskeletal and neurodegenerative diseases.” Traditional clinical trials can be slow,
expensive and closed to any participants who are not near enough to a research site or do not have the means to make multiple visits. Recruitment is such an issue that up to 86% of clinical trials do not achieve their enrolment targets in the desired time(6,7)
. In contrast, the
DeTAP trial recruited 94 patients in just 12 days using social media (versus six in 28 days using traditional methods) with a wait list of 300 more. Additionally, 86% of participants (69/80) expressed willingness to continue in a further 12- to 18-month-long trial. Data collection is inevitably a key measure of
success for a clinical trial. Patients typically have to travel to a clinic for a researcher to take their measurements. In DeTAP, participants used FDA-approved devices connected to Huma’s app and 99% of all ECG and BP measurements were completed, along with 91% of televisits and 85% of surveys. Dr Arrash Yassaee, global clinical director at
Huma, says: “DCTs are the future of clinical trials, but there has been a dearth of evidence to show how well fully decentralised trials work in the real world, particularly for complex cases This study shows they can be safe, rapid, engaging and incredibly useful. Anyone wishing to run a fully decentralised trial, particularly in the cardiovascular space, should take note.” The research, ‘Pandemic-proof recruitment and engagement in a fully decentralized trial in in npj Digital Medicine.
Outsourcing in Clinical Trials Handbook | 41
References 1. Jacques, R., Ahmed, R., Harper, J., Ranjan, A., Saeed, I., Simpson, R. and Walters, S., (2022). Recruitment, consent and retention of participants in randomised controlled trials: a review of trials published in the National Institute for Health Research (NIHR) Journals Library (1997–2020). BMJ Open, 12(2), p.e059230.
2. Xue, J., Smietana, K., Poda, P., Webster, K., Yang, G. and Agrawal, G. (2020) Clinical trial recovery from COVID-19 disruption. Nature Reviews Drug Discovery, 19(10), pp.662-663.
3. 4.
https://bmjopen.bmj.com/content/10/4/e034778 5.
https://pubmed.ncbi.nlm.nih.gov/35723914/ 6.
https://www.sciencedirect.com/science/article/pii/ S155171441730753X?via%3Dihub
7.
https://www.nature.com/articles/d41573-020-00150-9
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