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
In a phase II study assessing the prophylaxis of a nasal powder in subjects challenged with rhinoviruses, subjects were asked to self-report symptoms at 27 time points over 12 days. On 7 of the 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, trial managers needed to engage their subjects and ensure their convenience. To do so, they tapped the ability of OpenClinica Participate to present clear, attractive eCRFs to patients right on their own mobile device or laptop. Data managers established rules that fixed the date of all future study events based on the date of enrollment. OpenClinica Participate automatically sent text messages and emails to each subject hours prior to a scheduled event, directing them to the relevant data capture form regardless of which of their devices they happened to be accessing at the time. (This is a best practice, with hours spent online per day continuing to grow around the world. And while a crowded “app” field may fragment populations – a Snapchat user is not necessarily an Instagram user – an email client and SMS messaging feature can almost always be found, and found running, on any web-enabled mobile device.)
In this case, success would mean the vast majority of study subjects not only entering their data, but doing so in real-time; that is, once in the morning, once in the afternoon, and once in the evening on each of those 7 critical days. And that’s just what happened.
Of the 115 subjects who completed at least one of the 27 ePRO forms, even just a basic intake form, 89 (77%) completed all of the 21 forms required in the morning, afternoon and evening of seven consecutive days, when timely reporting was most critical.
Of the 1,892 “3x daily” forms completed, the vast majority were completed in “real-time”:
|Forms Completed||Within 4 Hours |
(of 6am, noon and 5pm
|% Within 4 Hours|
“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.