gms | German Medical Science

53. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

15. bis 18.09.2008, Stuttgart

The use of ePRO technology to support trial site procedures

Meeting Abstract

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  • Rainer Richter - Grünenthal GmbH, Aachen, Deutschland

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 53. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds). Stuttgart, 15.-19.09.2008. Düsseldorf: German Medical Science GMS Publishing House; 2008. DocINT1-4

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Veröffentlicht: 10. September 2008

© 2008 Richter.
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Grünenthal has used ePRO (electronic Patient Reported Outcome) technology to not only collect patient data but also to support the site personnel during clinical trial conduct.

We will summarize our experience gained in three acute pain trials and focus on the critical items when setting up and conducting an ePRO trial in this clinical setting.


The use of ePRO systems to collect patient data is already well established in clinical trials. In particular clinical trial settings we have recognized that ePRO can also offer additional benefits that can assist the clinical site staff during conduct of the trial.

Our experience is based on three clinical trials conducted in approximately 1400 patients where we were assessing pain after surgery. The requirements of all three trials were very similar. Hospitalized patients were treated after surgery and medication was provided in a flexible dosing design (patient decided by when he wants to be dosed).

The pain assessments required from the patient were to be entered into the ediary directly before each dosing and also at fixed time points after each dosing (0.5; 1.0; 1.5; 2.0; .. hours after intake).

Other trial assessments such as vital signs, ECG and blood sampling were also done related to each study medication intake and certain assessments were related to the first intake of study medication.

Alarms were included in the ediary to remind both patient and the site staff to make certain assessments.

We will summarize our experience in these three trials and will focus on critical items in setup and conduct of the trials from a patient and site staff perspective. After smooth conduct of our phase IIb trial the challenges we encountered when setting up two complex phase III trials will also be illustrated.

In our opinion extensive user acceptance testing is critical and all issues must be solved before going live. Cross functional participation from the beginning is essential and training of investigators, site staff and monitors is key for a successful execution of a trial.

Despite all issues we are convinced that electronically collected patient outcome data are more accurate and complete in comparison with paper diaries. The additional benefits we have seen in this particular clinical setting have proved to be valuable to the smooth conduct of the trial and helped both patient and site staff acceptance of this new technology.