Novel pharmaceutical development is defined as the process performed to develop novel medicines. This activity is carried out by pharmaceutical companies, academics and government agencies and involves clinical trials in healthy volunteers and patients to test the efficacy and safety of new medicines. These activities routinely require the collection of blood samples using standard venous blood draw approaches in a clinical setting.

This group is interested in patient centric sampling technologies for their potential to improve clinical trial processes and bring novel drugs to the market faster and at lower costs. This includes enabling the unsupervised and unscheduled collection of samples in a geographical location that is more convenient to the subject, i.e. the home, and in regions remote from routine healthcare facilities. Further, smaller blood volumes facilitate sampling from vulnerable groups such as children, the elderly and the severely ill. In addition, this approach may help with the recruitment and retention of subjects on clinical pharmaceutical development trials and assist with understanding patient compliance in taking the medicine. Further, the small volumes enable the collection of additional samples to give richer data sets, additional endpoints, to gather data during clinical events and enable improved patient monitoring. A further benefit is the possibility of generating additional cost savings if samples are shipped and stored at room temperature.

In order to implement novel blood sampling approaches for clinical trials, clinical investigators and local healthcare regulators need to be assured that the information derived from their use is of acceptable quality, will be accepted by regulators and is not going to result in increased risk to the subject. This requires a high degree of training for users and ongoing active monitoring of all the processes involved.

References

 

Case Studies

Clinical Trials Conduct

Giving patients choices: AstraZeneca’s evolving approach to patient-centric sampling. Bailey, C., et al. Bioanalysis 12, 957-970, doi:10.4155/bio-2020-0105 (2020).

Decentralized Clinical Trials: The Call for a New Paradigm. Thoelke, K. & Licholai, G. – https://media.xconomy.com/wordpress/wp-content/images/2020/04/16162050/Decentralized-Clinical-Trials_White-Paper_15APR2020.pdf (2020).

Leveraging Digital Health Technologies and Outpatient Sampling in Clinical Drug Development: A Phase I Exploratory Study. Dockendorf, M. F., et al. Clin Pharmacol Ther 105, 168-176. doi:10.1002/cpt.1142 (2018).

An Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs. Kothare, P. A. et al.. AAPS J 18, 519-527, doi:10.1208/s12248-015-9860-3 (2016).

Merck’s perspective on the implementation of dried blood spot technology in clinical drug development – why, when and how. Xu, Y. et al.. Bioanalysis 5, 341-350, doi:10.4155/bio.12.321 (2013).

 

Pharmacokinetics

Implementing dried blood spot sampling for clinical pharmacokinetic determinations: considerations from the IQ Consortium Microsampling Working Group. Evans, C. et al.. AAPS J 17, 292-300, doi:10.1208/s12248-014-9695-3 (2015).

Pharmacokinetic considerations as to when to use dried blood spot sampling. Emmons, G. & Rowland, M.. Bioanalysis 2, 1791-1796, doi:10.4155/bio.10.159 (2010).

 

Biomarkers

Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis. Xing J. et al.. Bioanalysis 12(13) 919-935, doi.org/10.4155/bio-2020-0063 (2020).