Mobile Patient Reported Outcomes (mPRO)

• Real time analysis - The opportunity for real time analysis ensures high compliance, real time outcome data and real time statistical significance, and reduces timelines between drug discovery and launch.
  
  
• Remote monitoring - Remote, anytime access to individual participant reported information and biometric data from devices such as glucometers, scales, BP monitors and spirometers.
  
  
• Secure messaging - Researchers and staff can communicate securely with their study subjects through the encrypted messaging system or by text messaging.

Many drugs, biologics and medical devices in the pharmaceutical discovery and development pipeline hold the promise of reducing the impact of health problems in everyday life. The development process, however, is a complex and challenging one.

To introduce new treatments, regulators, sponsors, payors and patients need to fully understand their safety and value. The collection of accurate patient reported data in the development process is essential.

Missing and invented data has a significant impact on the study’s ability to detect treatment related differences. Estimates suggest it can be necessary to recruit four times as many people for a study where you have 50 per cent of data missing, to achieve the same statistical power as a study with no missing data.

Vodafone mobile Patient Reported Outcomes (mPRO) uses web and mobile technology to improve the collection and management of patient reported data.

Once a questionnaire has been agreed and validated, it is remotely loaded onto a mobile handset and is immediately ready to deploy. The mobile based diary can include many question types and use numeric and visual analogue scales as appropriate. This unique and flexible system means that most question types can be replicated on an easy to use mobile device.

The patient enters a code to access the questionnaire, the simple tap and go interface guides them through their assessments and makes data entry fast and easy. Entries are time-stamped enabling compliance analysis.

Vodafone mPRO helps to ensure entries are complete and legible and that no questions have been left blank.

As soon as the patient has completed the questionnaire it is automatically encrypted and securely transmitted.

If the network is not available, then the questionnaire is stored in the outbox on the handset and then sent automatically once connectivity is back. No patient data is stored on the mobile device itself, ensuring no data is lost in the event the patient misplaces their mobile device.

If validated metrics are required and acceptable within the study protocol, clinical trial staff can communicate with the patient through an encrypted messaging system or by text message. Messages that are sent to study subjects are logged for audit purposes.

To increase the accuracy of data submitted, the application also has the capability to receive medical device data from Bluetooth compatible devices, for example glucometers, scales, blood pressure monitors and spirometers.