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

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