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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Patient-directed data capture for clinical research: A pilot study testing two platforms.

Satoshi Shoji1, Lauren Cohen2, Keith Marsolo2

  • 1Duke Clinical Research Institute, Durham, NC, USA; Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.

Contemporary Clinical Trials
|October 29, 2025
PubMed
Summary
This summary is machine-generated.

Patient-directed electronic health record (EHR) data capture is feasible via application programming interfaces (APIs), but records requests show low success. Improved workflows and user support are needed for broader adoption.

Keywords:
Application programming interface (API)Data retrievalElectronic health recordsMedical records requestPatient-directed data capture

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Area of Science:

  • Health Informatics
  • Patient Engagement
  • Electronic Health Records

Background:

  • Patient-directed data capture allows individuals to access and share their electronic health record (EHR) data.
  • This approach can enhance patient engagement and reduce data fragmentation.
  • The practical feasibility and reliability of current patient-directed data capture methods are not well understood.

Purpose of the Study:

  • To evaluate the feasibility of different patient-directed data capture platforms.
  • To compare the effectiveness of API-based versus records request methods for EHR data retrieval.

Main Methods:

  • A pilot study involving 34 heart failure patients at Duke Health.
  • Participants used Hugo Health (API-based retrieval) and/or Datavant (records requests).
  • Feasibility and data retrieval success were assessed for each platform.

Main Results:

  • API approach retrieved 88% of records; records request retrieved 20%.
  • API captured external terms but missed some local EHR diagnoses; records request had higher data omission.
  • Low willingness to reuse vendors (22%) and need for onboarding support (33%) were observed. Technical challenges included JSON file processing and manual PDF abstraction.

Conclusions:

  • Patient-directed data capture is technically possible, with significant method-dependent variability.
  • API-based retrieval shows high success rates, while records requests are less successful.
  • Enhanced workflows and user support are crucial for widespread feasibility of patient-directed EHR data capture.