Decentralized clinical trial design usingblood microsampling technology for serumbioanalysis: supplementary materials

Background: Alternatives to phlebotomy in clinical trials increase options for patients and cliniciansby simplifying and increasing accessibility to clinical trials. The authors investigated the technical andlogistical considerations of one technology compared with phlebotomy. Methodology: Paired sampleswere collected from 16 donors via a second-generation serum gel microsampling device and conventionalphlebotomy. Microsamples were subject to alternative sample handling conditions and were evaluatedfor quality, clinical testing and proteome profiling. Results: Timely centrifugation of blood serummicrosamples largely preserved analyte stability. Conclusion: Centrifugation timing of serummicrosamplesimpacts the quality of specific clinical chemistry and protein biomarkers. Microsampling devices withremote centrifugation and refrigerated shipping can decrease patient burden, expand clinical trialpopulations and aid clinical decisions.