ePROs in diabetes clinical trials

Diabetes has rapidly become a global epidemic affecting more than 238 million people. That number is expected to increase to 438 million people by the year 2030. The economic burden of the disease totalled $376 billion in 2010. As such, biopharmaceutical companies and researchers around the world are working to identify new, effective and safe treatments to help this growing patient population.

With the growing importance of PRO measures in the care and treatment of people with diabetes has led to the development of a variety of diabetes-specific outcome measures to assess the impact of living with diabetes and its treatment including, quality of life, health-related quality of life, health status, treatment satisfaction, and symptoms in which data are collected directly from patients on diaries and/or questionnaires, printed either on paper or available on electronic devices.

The use of electronic patient reported outcome (ePRO) data in clinical trials is increasing as regulatory authorities acknowledge the credibility of such data, particularly in comparison to paper and pencil self-reports completed in unsupervised settings.

Migrating from paper to electronic data collection is a significant movement in the field of PRO measurement with a range of modalities available for data collection including: smartphone (handheld), tablet, IVR, and Internet.

The level of evidence to support the comparability or measurement equivalence of the ePRO to the paper-based PRO from which it has been adapted will vary in accordance with the magnitude of the modification and its effect on the content, format, and interpretation of the PRO items and scales. There is substantial evidence however to suggest that the psychometric properties of the original measure will still hold for the ePRO version if only minor modifications have been carried out,

ePRO migration challenges

 While the reuse of validated questionnaires seems intuitive and practical, there remain some obstacles to transitioning questionnaires to electronic versions in clinical trials.

  • Developers do not license screen shots of validated instruments and this makes it difficult for ePRO providers to provide fully reusable versions of questionnaires based on a published specification.
  • Sponsors often regard validated instruments as private assets and a competitive advantage, and are reluctant to publish any studies done to establish the validity of such assets.
  • Additionally, the compensation of the authors and copyright holders of the questionnaires necessitates licensing of copyright and other logistical matters.

The virtue of providing validated instruments to the industry

At large this is certainly recognized, and academic societies, industry groups, and distribution channels are evolving to support this need. One such group which has recently formed is the ePRO Consortium which is working with the Critical Path Institute on this goal.

This September sees the publication in Applied Clinical Trials the peer-reviewed paper by Keith Meadows and Chris Hall – ‘ePRO on diabetes Studies’ which describes some of the key advantages in the use of ePROs in diabetes clinical trials and studies.

You might like to read our other publications on ePROs and outcomes so please visit our Publications & Downloads page

Categories: Patient reported outcomes

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