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Related Experiment Videos

Pen-based remote data entry system. A pilot clinical trial

I Beinlich1, C Bokemeyer, U Räth

  • 1Padcom GmbHa, Bonn, Fed. Rep. of Germany.

Arzneimittel-Forschung
|March 1, 1993
PubMed
Summary

Pen-based remote data entry is a feasible method for collecting clinical trial data. This system enhances data quality and offers benefits for both physicians and study sponsors.

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Area of Science:

  • Clinical research informatics
  • Medical technology
  • Health data management

Background:

  • Traditional paper-based data collection in clinical trials can be inefficient and prone to errors.
  • Electronic data capture (EDC) systems aim to improve data quality and streamline trial processes.
  • Pen-based systems offer a potentially more user-friendly interface for EDC compared to traditional desktop computers.

Purpose of the Study:

  • To evaluate the feasibility of using a pen-based remote data entry system in a clinical trial.
  • To assess the acceptance of this technology by both patients and healthcare providers.
  • To identify the benefits and challenges associated with pen-based data entry in a real-world clinical setting.

Main Methods:

  • A phase-I/II clinical trial involving 20 testicular cancer patients treated with chemotherapy and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF).

Related Experiment Videos

  • Data collection using a pen-based computer system with 33 electronic forms, capturing 798 data points per patient.
  • Direct interviews with physicians and patients post-system use to gauge acceptance and usability.

    • Main Results:

    • Patients found the pen-based system superior to desktop computers during interviews and accepted electronic note-taking over paper.
    • Physicians reported initial additional effort but anticipated later time savings due to reduced data clearing and improved data quality.
    • The system demonstrated feasibility for recording diverse clinical data, including medical history, staging, therapy, and side effects.

    Conclusions:

    • Pen-based remote data entry is a viable and effective method for clinical data recording.
    • The technology offers tangible benefits, including enhanced data quality and efficiency, for investigators and study sponsors.
    • Patient and physician acceptance suggests potential for broader adoption in clinical research.