CPSA USA 2019

Clinical and Pharmaceutical Analysts United:
Human Wellbeing is Our Responsibility

Patient-Centric Sampling Interest Group

Achievements and Next Steps

Wednesday, October 30, 2019
10:15 am - 11:45 am
Sheraton Bucks County Hotel
Langhorne, Pennsylvania

PCSIG Colloquium at CPSA USA 2019
  • Introduction to PCSIG, Current Activities and how to get involved
    Presentation by Neil Spooner
    CPSA USA 2019 Patient Centric Sampling Interest Group
  • Standardization of metadata associated with the use of patient centric blood sampling devices for the quantitative determination of circulating analyte concentrations
    Discussion led by Søren Therkelsen and Neil Spooner
    PCSIG Project Idea Form
    • Document has been submitted to CLSI, IVD Industry Connectivity Consortium & Fast Healthcare Interoperability Resources – FHIR
    • Timelines to establish a standard can be restrictive - 5+ years
      • Looking at faster approaches
  • Realising benefits of patient centric sampling in Clinical Trials
    Presentation and discussion led by Erwin Berthier
    Realizing patient-centric samples in clinical trials
    • Proposal to run a clinical trial to quantify benefits such as improved recruitment, retention and engagement as these are seen as potential blockers to the further implementation of patient centric sampling and analysis technologies
      • Will be designed to benefit all involved and published – non-competitive collaborative working
    • Looking for active participants to help design and implement a trial
    • It is likely that the information obtained from the proposed clinical trial will also help the transition of these technologies into more routine use in healthcare outside clinical trials
    • Need to consider which devices (if any) should be included
    • Ideas for analytes included biological drugs, lithium, immunosuppressants
    • Will have outline proposal for the trial by CPSA Europe (4-7 Feb 2020)
  • Other discussion points
    • Currently the technology only fits where it demonstrates a clear benefit over standard sampling – e.g. pediatric, remote areas, critically ill, obtaining extra data away from the clinic, sampling during a clinical event, rare diseases, etc
    • Need to increase understanding of the technologies in the clinical departments of large CROs and Pharma to spread it beyond this
    • For implementation to be successful, each organisation needs to find champions in each department involved

    << Back to Program