Clinical trial sites were moreover required to have real-time access to the captured data and to receive alerts to potential protocol contraventions. Our solution enabled diary completion within a small time frame as well as allowed the research teams to access the captured information instantaneously and receive prompt alerts.
Greater emphasis is now being placed on the effective collection of patient reported outcomes (PRO) data in order to support regulatory submissions.
In the case of one large clinical trial sponsor, there were special challenges relating to the timing of PRO data capture for Phase 2 Smoking Cessation study. The subjects were heavy smokers (minimum of 30 cigarettes per day) and were required to answer seven questions before 9am, daily for six months. Additionally,clinical trial sites were required to have real-time access to the PRO data and receive alerts to potential protocol contraventions.
The study was supported by leveraging a mobile-web based PRO solution that enabled diary completion within a small time frame (as the subject was getting ready to start the day). Our solution allowed the research teams to access the captured information in real-time and receive timely alerts. Crucially, subjects could access our PRO diary through their own mobile handsets, making access unobtrusive and, as the diary was simple and user-friendly in design, easy for subjects to complete.
Our PRO solution is configured to match the requirements of study protocol. Once enrolled, the subjects’ mobile phone number and email address (when appropriate) are entered into a secure website. Subsequently, the website provides a useful reference point to help site staff manage their day to day tasks.
"All subjects enrolled into the study completed their diary over the six month period and reminder driven diary compliance was 91%"
Patient communication is pre-defined and automated throughout the trial. A text message and email are sent at the correct time to the subject with a URL link to their diary. The subject opens the message and follows the link either using their mobile handset or any standard web browser. They enter their secure log-in credentials to complete the diary questions.
As each page is completed the data is saved on the server, providing a full date and time stamped audit trail. The site has immediate visibility over the blinded data. The system performs routine checks across the data triggering alerts, reminders and new work flows if and when appropriate.
After the decision was made to extend the study, subjects were invited to continue their involvement in the study by text message and asked to complete their daily diaries without active site engagement. This extension was rolled out to all subjects with minimal disruption to both the patient and site.
The initial six-month trial was successful and led the sponsor to extend the study by a further six months. Below are the main acknowledged benefits.
- High compliance – all subjects enrolled into the study completed their diary over the six month period and reminder driven diary compliance was 91%. Over the extension period, subject diary compliance was 82% and over the entire study diary compliance was 87%
- High retention – subjects confirmed that using their own mobile handsets made diary entry and completionunobtrusive and easy to manage
- High quality data – diary entries are date and time stamped and diary input is algorithm-controlled, ensuring high quality data is captured that requires none or limited re-validation
- Real-time interrogation – diaries are transmitted in real-time to a secure central server, enabling research teams to review and interrogate data as it is captured
- Easy to deploy – no logistical challenges are presented to provisioning the diary to patients as no specialist devices are required
- Regulatory Compliant – the system is validated, available in all languages, has a full audit trail and is compliant with all ePRO regulations (including FDA 21 CFR Part 11, HIPAA and country-specific data privacy requirements)