Pfizer has tapped Exco InTouch to use its eDiary technology for the mobile-enabled Participatory Patient-Centered (PPC) clinical trial that we first reported on earlier this month. At the time Pfizer called the trial the first FDA-approved clinical drug trial involving all-electronic home-based reporting. Trial participants will receive medication via the mail and use the mobile application to participate in the study. The drug being “tested”, Detrol, is intended for use by patients with overactive bladders and has already been FDA-cleared. The study is officially and acronymically called the Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) Phase 4.
Exco InTouch has been in the mobile-enabled clinical assessment business since 2004. As of June 2010, the company had supported more than 500,000 patients in more than 60 countries. Exco had facilitated more than 3 million text messages for its customers, which include 16 of the top 20 pharma companies. Exco's offering allows participants to use their own mobile phones, but can provide handsets if necessary. The researchers need only enter the patients name and phone number to send the Exco mobile app to the participant's mobile phone over the air (OTA). After granting permission, the participant then receives a text alert that the app is now installed.
Patients will report in via the internet using online portals and mobile phones. InTouch's eDiary system includes questionnaires sent via a series of text messages. If the patient doesn't respond within a certain timeframe, a text message reminder can be automatically sent in order to prompt a response. ePro spans three validated ePRO solutions, including simple diaries to the most complex clinical assessments, all of which can be customized to meet the requirements of individual trials, according to the company.
The REMOTE trial is expected to save researchers time, yield more accurate results, increase patient compliance and engagement, lower withdrawal rates, and enable real-time data. Perhaps most notably it will be less expensive than traditional clinical trials.
“The REMOTE virtual trial pilot brings great potential to transform how patients access and participate in clinical trials,” stated Miguel Orri MD, Senior Director and Clinical Lead of Pfizer in a press release. “The project brings the potential to accelerate clinical research while improving quality, measures vital to the future of drug development.”