Co-Creation of the EpiCom Clinical Trial: Bringing the Tuberous Sclerosis Complex Patient Community, Healthcare Professionals, and the Pharmaceutical Industry Together
Moore-Ramdin et al.
The finding, in our words
The EpiCom study was co-created with patients, caregivers and healthcare professionals to optimise a decentralised clinical trial framework that reduces participant burden through remote assessments and broader eligibility criteria, highlighting the value of stakeholder collaboration in trial design.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
This study used home self-collected saliva samples to successfully monitor cytokines and cortisol in mothers and infants, finding that a community singing intervention significantly reduced salivary interleukin-6 levels in mothers with postnatal depression.
Kirkpatrick et al., Brain, behavior, and immunity (paywalled) · source ↗
Frequent dried blood spot sampling detected early changes in beta-cell function more effectively than mixed-meal tolerance tests or urine ratios, supporting its potential as a decentralised monitoring tool for clinical trials.
Dunseath et al., Diabetes care (paywalled) · source ↗
Home spirometry gave slightly lower percent-predicted FEV1 values than office measurements cross-sectionally, but the three-month change in lung function did not differ significantly between settings. This suggests home spirometry can reliably detect treatment effects, supporting its use as an endpoint for decentralised cystic fibrosis trials.
Rosenfeld et al., Annals of the American Thoracic Society (paywalled) · source ↗
Worked case studies of patient-centric sampling deployed in pharmaceutical drug development: how sponsors have implemented it, rather than whether it is possible.
Patel et al., The AAPS Journal (paywalled) · source ↗
A study of 292 patients found that the slopes of home-collected stimulated dried blood spot C-peptide levels over six months predicted 12-month venous mixed-meal tolerance test results, P<0.001. This shows decentralised microsampling can monitor beta-cell function, though further validation is required to confirm its reliability and broader applicability.
Hendriks et al., Diabetes care (paywalled) · source ↗