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Cell Phone Technology in Clinical Trials: Mobile Patient Reported Outcomes (mPRO)

Clinical Research

Cell Phone Technology in Clinical Trials: Mobile Patient Reported Outcomes (mPRO)

Cellular/ mobile phone has become an essential part of life in this modern world. A recent survey states that the number of worldwide cell phone users would reach 6 billion compared to the Internet users whose number is 32.7% of world’s population, by the end of 2012. The cell phone technology is added with many advanced applications into various fields. One of the major applications of cell phone technology is in the clinical research domain.

Till date, web technology is being used for certain applications in clinical research. Now the cell phone technology is being implemented in some applications like patient reported outcomes (PRO). FDA defines a PRO as a measurement of any aspect of a patient’s health status that comes directly from the patient (i.e., without the interpretation of the patient’s responses by a physician or anyone else). Let’s have a brief explanation of using the mobile technology in PRO.

The paper based Patient Reported Outcome has its own drawbacks like manipulation of data, retrospective entry of dairies i.e. entering the data after a prolonged duration of the specific event, false data acquisition etc. Mobile Patient Reported Outcome (mPRO) is facilitated to time stamped data acquisition, validated data entry hence no need for double data entry, spontaneous data transfer to the sponsor company etc. mPRO is an advanced application of eDairies in which the Personal Digital Assistant (PDA) was used. PDA is a very costly instrument and requires training to operate the device. It uses any of the available networks to transmit the data from the device to the sponsor site. It often fails to transmit the data in case of non availability of network. These problems can be rectified by mPRO.

mPRO is a mobile application that works in any mobile phone that has a browser and data connectivity options. This is in accordance with FDA 21 CFR part 11 and hence the data entered and transmitted through the device is highly secured and safe. The device requires patients Personal Identification Number (PIN) to fill the dairy and submit. In case of loss of device, the data can be protected as the data is not stored in the device and transmitted immediately once it is entered. As the data is immediately transferred to the sponsor database automatically, the mPRO device can be considered as disposed item and retained by the patients at the end of the trial.

The mPRO mobile device also assists the site staff to send the reminder SMS for scheduled visits, non-compliance, etc. to the study participant and helps in continuous contact with the subject. Hence it can be concluded that mPRO enhances the ease of patient reported outcome, secured data acquisition, and is a cost effective device than PDA, which can be retained by the patient at the end of the trial.

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