EBF Open Symposium
EBF Barcelona

15th EBF Open Symposium

Towards harmonised implementation of the ICH M10 Guideline
15 November 2022
The Bioanalytical Compass - Navigating to our True North
16-18 November 2022

Title: Smart Trials:  Assessment of At-Home Sampling and Digital Health Technologies in a Clinical Pilot Trial
Presenter: Philip Timmerman
Company / organisation:  MSD
Biography: Dr. Bateman is currently a Distinguished Scientist and the Scientific Lead for Bioanalysis in the Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism at Merck & Co. where he has worked for 20 years.  He is one of the architects of the Merck Smart Trials initiative and is focused on developing and implementing patient-centric sample collection technologies.  He is currently employed at Merck Research Laboratories in West Point, PA.
Abstract: Smart Trials is a cross-functional innovation project at MSD aimed at enabling a more patient-centric clinical trial approach.  As part of this initiative, clinical pilot studies are conducted to test feasibility of new technologies/methods for future clinical use in 3 areas: smart sampling (technologies for collection of date/time stamped outpatient PK and PD samples), smart dosing (technologies to accurately record and transmit dosing information), and smart analytics (methods to collect, integrate, and visualize data in real-time).  In the most recently completed clinical pilot, 16 healthy subjects were administered once-daily sitagliptin packaged in smart blister packs (Period 1, 14 days) or a traditional bottle (Period 2, 3 days).  Fingerstick DBS samples were collected for PK analysis on select study days, both in-clinic and at-home.  Date/time of dose administration and PK sampling were recorded by the subjects in eDiaries in Period 1 and by clinic staff in Period 2.  In-clinic PK samples were also collected using microneedle-based sampling from the arm.  Most subjects (15/16) were generally compliant with dosing instructions.  Self-reported dosing dates/times in the eDiaries were in general agreement with those captured by the smart blister pack.  There was no meaningful difference in fingerstick DBS sitagliptin concentrations from samples collected at home vs. in-clinic.  According to questionnaire responses, subjects generally would agree to participate in clinical studies that used the smart technologies evaluated and found fingerstick DBS sample collection easy to do at home.  The results demonstrated the feasibility and subject acceptance of smart technologies for future clinical trial use and highlighted areas for future research.