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Leveraging Digital Health Technologies and Outpatient Sampling in Clinical Drug Development: A Phase I Exploratory

Marissa F Dockendorf1, Gowri Murthy2, Kevin P Bateman1

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Summary

This study shows that digital tools and outpatient dried blood spot sampling are feasible for collecting clinical trial data. These methods were well-accepted by participants, improving data collection and decision-making.

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Area of Science:

  • Clinical pharmacology
  • Digital health technologies
  • Pharmacokinetics

Background:

  • Merck & Co is exploring digital health technologies to enhance clinical trial data and decision-making.
  • This includes investigating outpatient sampling and real-time data access.

Purpose of the Study:

  • To assess the feasibility and subject acceptance of digital adherence monitoring and outpatient dried blood spot (DBS) sampling in a clinical trial setting.
  • To evaluate the use of a smart bottle for electronic dispensing data capture and an electronic diary for sample collection time recording.

Main Methods:

  • A fixed-sequence, two-period phase I trial involving 16 healthy subjects.
  • Sitagliptin (50 mg once daily) was administered in period 1 (smart bottle) and period 2 (traditional bottle).
  • Dried blood spot samples were collected on select days, both in-clinic and at-home, with time recorded via electronic diary (period 1) or by staff (period 2).

Main Results:

  • Demonstrated feasibility of collecting digital adherence data and outpatient DBS samples.
  • Confirmed subject acceptance of these novel data collection methods.
  • Highlighted areas for future optimization of digital health technologies in clinical trials.

Conclusions:

  • Digital adherence data and outpatient DBS sampling are viable methods for enhancing clinical trial data.
  • These approaches show promise for improving decision-making in drug development.
  • Further refinements are needed to fully leverage these technologies.