OS 26-03 MOBILE DEVICE BASED ELECTRONIC DATA CAPTURE SYSTEM IN PHARMACEUTICAL CLINICAL TRIAL: A FEASIBILITY STUDY

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Abstract

Objective:

To evaluate the feasibility and acceptability of a mobile device based electronical data capture (mEDC) system applied in one randomized clinical trial (RCT).

Design and Method:

The mEDC, an android smartphone-based application, was developed to support real-time data capture, project management and quality control in a multicenter randomized double-blinded parallel controlled pharmaceutical trial. Four user interfaces are shown in Figure 1. The RCT is to evaluate the efficacy of telmisartan (40mg) and hydrochlorothiazide (25mg) monotherapy in high sodium intake patients with mild to moderate hypertension in 14 hospitals, including one baseline survey and three follow-ups. A designated qualitative study was conducted to evaluate its feasibility and acceptability during implementation of project. Fifteen investigators, including fourteen doctors and one nurse in local hospitals, two clinical research associates (CRA) and one senior data manager were interviewed by personal depth, face-to-face interview. Nvivo 9.0 was applied to analyze the records and theme framework method was used to obtain outcomes.

Results:

With support of mEDC, 1333 patients were recruited, and 1037 patients of them successfully completed all visits during 2 months. The average time was needed around 53 minutes for 141 questions of all visits per patient. Nearly all the interviewees were satisfied with the features of smooth manipulation, user-friendly interface, real-time data transfer, procedure control, patient screening, central randomization, blinded drug allocation, visit organization, automatic data check and real-time remote monitoring. The average satisfaction score was 9.2 (10 as full mark). All the investigators and CRAs expressed their expectation of using the app again in the future. The senior data manager evaluated the mEDC and found it safe in data transferring and storage. Very rare occasion of unstable wireless internet access was complained by investigators.

Conclusions:

mEDC was a feasible and acceptable tool to support RCT. High quality research may benefit from mEDC's real-time and multi-user features.

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