What does the term “source” bring to mind for you? Paper files? A clinic’s EMR? Fair enough. Those are the typical formats of source data in clinical trials. But when you think about it, those records are a few removes from the true source: the patient.
Granted, most trials depend on a host of instruments and analyzers. No patient can self-report their own hemoglobin levels. But there are measures, such as quality of life, whose source really is the patient’s own experience. And for an industry whose raison d’être is enhancing (and sometimes saving) lives, we have a hard time obtaining those measures.
That’s not to say that patient-reported outcomes are a rarity in clinical trials. In fact they’re common. But so are obstacles to collecting them. Even today, with several ePRO solutions on offer, too many trials rely on patients to complete paper diaries. But paper records are prone loss or damage. Also, it’s virtually impossible to tell whether a patient made daily diary entries as instructed, or retrospectively wrote responses just prior to a study visit, raising data quality concerns. (Here’s a great analysis of “parking lot syndrome”.)
ePRO is a big improvement on paper, but it doesn’t integrate seamlessly into a patient’s day to day life. Nearly all trials today using an electronic system for PROs provision dedicated devices to patients for this purpose. Patients need to be trained on how to use this device, recall that training at the relevant time, and make a habit of keeping the device on their person to stay current with reporting tasks. These systems also require patients to remember passwords and other access credentials. A step as apparently simple as downloading an app can be fraught with challenges: the patient must remember their app store login, locate the download area, have sufficient memory on their phone to house and run the app, ensure the app installs successfully, and ensure it remains installed, running, and updated.
All of the above examples are potential points of failure that can compromise the quality of real world data and increase trial costs. These myriad tasks and responsibilities unrelated to the data itself can place a significant burden on a volunteer patient, particularly one who is very sick.
OpenClinica Participate eliminates potential points of failure by:
- providing an system that can be used on the patient’s own device(s),
- eliminating the need to patient’s to remember login credentials, and
- removing the complexities associated with apps.
This helps place the patient at the center of the research. And perhaps best of all, OpenClinica Participate places the patient reported data into the master EDC database in real-time with zero additional effort.
The advantages of this approach aren’t just theoretical. OpenClinica and its partners have realized their benefits in more than 20 studies since the launch of OpenClinica Participate about a year and a half ago. In this post and future ones in this series, I’d like to share some short and informal case studies. I call this one:
On time, nearly every time
S-cubed, an innovative pharmaceutical consultancy and contract service company, based in the UK and Denmark, recently supported a study assessing a medication to protect against a virus associated with the common cold. In the study, subjects were asked to self-report symptoms at multiple time points per day over several days. On most days, self-reports were to be submitted in the morning, in the afternoon, and at night. To help drive compliance with this rigorous self-reporting schedule, study managers wished to engage their subjects and ensure the data capture method was convenient. To do so, they tapped into the ability of OpenClinica Participate to present clear, attractive eCRFs to subjects on their own mobile devices (smartphone, tablet, or laptop). S-cubed data managers established rules that fixed the date of all future study events based on the protocol events schedule and each subject’s date of enrollment. OpenClinica Participate automatically sent text messages and emails to each subject prior to a scheduled event (and at the end of the time window if the diary was not completed), directing them to the relevant data capture form.
The data collection process involved no offline component. Subjects always provided their reports on a connected device, without regard to the specificity of device or location, etc. Consequently, fine-grained metadata regarding the date and time of eCRF completion was available. This metadata provided compelling evidence that the experience afforded to patients by OpenClinica Participate drives widespread data entry and timelines.
Of the 92 subjects who completed at least one of the ePRO forms associated with the study, thus signaling intent to participate, 89 (97%) completed all forms required in the morning, afternoon and evening over multiple consecutive days, when timely reporting was most critical, Reasons for non-completion were sometimes outside of OpenClinica Participate’s control.
Of the all “3x daily” forms completed, the vast majority were completed in real-time, with approximately 93% being completed within 1- 2 hours of the scheduled timepoints.
97% form completion rate
93% on-time rate for “3x daily” forms
“Bring your own device” may not be the final frontier in ensuring patient convenience. Passive monitoring by nearly invisible devices is already a reality. But the principle will never change: let technology do the work, so people can live their lives.