Co-Creation of the EpiCom Clinical Trial: Bringing the Tuberous Sclerosis Complex Patient Community, Healthcare Professionals, and the Pharmaceutical Industry Together

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.

Community singing intervention reduces maternal salivary cytokines and enhances maternal-infant cortisol synchrony in postnatal depression: biological findings from the SHAPER-PND trial — Kirkpatrick et al., Brain, behavior, and immunity (paywalled) · source ↗

• dct
• cortisol
• self-collection
• pediatric
• hormones
• liquid
• saliva
• biomarkers

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.

Serial Dried Blood Spot C-Peptide Sampling, but Not Urine C-Peptide-to-Creatinine Ratio, Detects Early Preservation of β-Cell Function in New-Onset Type 1 Diabetes: Experience From the USTEKID Trial — Dunseath et al., Diabetes care (paywalled) · source ↗

• dct
• blood
• dbs
• dried
• pediatric
• urine
• biomarkers

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.

Home Spirometry as a Clinical Trial Endpoint in People with Cystic Fibrosis: Results of the OUTREACH Study — Rosenfeld et al., Annals of the American Thoracic Society (paywalled) · source ↗

• dct
• rpm
• pediatric
• digital-biomarker

Worked case studies of patient-centric sampling deployed in pharmaceutical drug development: how sponsors have implemented it, rather than whether it is possible.

Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug Development — Patel et al., The AAPS Journal (paywalled) · source ↗

• dct
• venous-agreement
• blood
• self-collection
• pediatric
• validation
• biomarkers

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.

Early Detection of β-Cell Decline Using Home Dried Blood Spot C-Peptide Levels in New-Onset Type 1 Diabetes — Hendriks et al., Diabetes care (paywalled) · source ↗

• dct
• venous-agreement
• blood
• dbs
• self-collection
• dried
• pediatric
• biomarkers