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Use of electronic data capture in a clinical trial on infant feeding

I Pawellek1, T Richardsen, D Oberle

  • 1Department of Metabolic Diseases and Nutrition, Dr von Hauner Children's Hospital, University of Munich Medical Centre, Munich, Germany.

European Journal of Clinical Nutrition
|December 6, 2012
PubMed

Insights

Electronic data capture (EDC) in clinical trials significantly reduces data checking needs. While planning electronic data capture requires more upfront time, it improves data accuracy and efficiency in childhood obesity research.

Area of Science:

  • Clinical Trials
  • Pediatric Research
  • Data Management

Background:

  • The European Childhood Obesity Project is a multi-center, double-blind, randomized clinical trial.
  • Investigating the link between early-life protein intake and later obesity risk in children across five countries.

Purpose of the Study:

  • To evaluate the use and effectiveness of electronic data capture (EDC) methods within a large-scale clinical trial.
  • To compare the efficiency and data quality of EDC versus traditional paper-based methods.

Main Methods:

  • Utilized electronic data capture (EDC) tools, specifically the Clindoc program for Remote Data Entry (RDE).
  • Compared data documented via electronic case report forms (eCRF) with paper-based case report forms (CRFs) over two study years.

Main Results:

  • 73.0% of visits were recorded using electronic case report forms (eCRF), compared to 27.0% with paper-based forms.
  • Electronic data capture significantly reduced the need for post-trial plausibility checks for anthropometric data (14.05% for eCRF vs. 35.61% for paper-based).

Conclusions:

  • Electronic data capture substantially decreases the necessity for extensive after-trial data verification.
  • The implementation of EDC requires a more intensive planning and setup phase prior to trial commencement.
Abstract

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