Decentralized Clinical Trial Design Using Blood Microsampling Technology for Serum Bioanalysis

Abstract

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 serum microsamples 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.

Tweetable abstract

Microsampling boosts #ClinicalTrials accessibility. This study shows collection of serum microsamples maintains a high degree of analyte stability for clinical chemistry and protein analytes. This technology may revolutionize clinical trials by expanding access. #Bioanalysis #HealthTech

Keywords:

• biomarkers
• clinical trial operations
• microsampling
• patient-centric sampling
• proteomics
• remote collection
• sampling device
• SomaScan
• TAP®

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.4155/bio-2023-0136

Author contributions

CG Rapp, MT Patel, D Mikhailov and AI Gusev conceptualized the project and designed the study. CG Rapp was responsible for study planning and execution. D Lee acquired the study after execution. J Loureiro conducted all SomaScan data analysis. CG Rapp conducted all hemolysis quantification and Chem-14 experiments. J Loureiro and D Lee conducted data interpretation for SomaScan. CG Rapp, D Lee, J Loureiro and D Mikhailov conducted data interpretation for Chem-14 and hemolysis data. D Lee, CG Rapp, J Loureiro, MT Patel, D Mikhailov and AI Gusev were responsible for the drafting and revision of the manuscript.

Acknowledgments

The authors thank Lili Yu and Arvind Kinhikar for their technical assistance and Jinming Xing for contributing to the study design. Furthermore, the authors are grateful to Gary Fujimoto, for support in facilitating IRB approval and Jennifer Vitagliano and Migena Pane for their direct clinical support in the conduct of the study. The authors also thank Tim Richards for providing insightful discussions and device training. Finally, thanks to NS, RR and DR for their valuable contributions to the discussion.

Financial disclosure

The authors have no financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Competing interests disclosure

Novartis is among the investors of YourBioHealth and provided financing to the company and is among YourBioHealth board members. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Ethical disclosure

The clinical protocol and informed consent form were approved by Institutional Review Boards before patient recruitment, and each patient provided written informed consent before enrollment. The clinical study was conducted in accordance with consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki and the International Conference on Harmonization E6 Guidelines for Good Clinical Practice (ICH GCP E6).

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2144/000112170