As an old clinical technology geek, I have always been interested in new advances in the collection of clinical trial data. Since my initial position in the industry in 1989, I have seen a lot of clinical data collection ideas come and go. I remember working with Remote Data Entry (RDE) in the early 90’s, then fax-based technology started taking off in the late 90’s, and finally the evolution of Electronic Data Capture (EDC) solutions beginning in the early 2000’s until it reached what I would consider the “stable” EDC solutions that we have today. And while there has been a lot of “odd ball” data collection systems that have filled in the cracks of that timeline (pen-based, Optical Character Recognition (OCR), etc.), I have been waiting for the next step of clinical data collection evolution that would supplant EDC for some time.
So it was with some interest that I followed Pfizer’s attempt to conduct a clinical trial using mobile smartphone technology from its announcement in 2011 to its abandonment of the project in 2012. I have often thought that the advent of smartphones and tablet PCs would ultimately usher in the next generation of clinical data collection. So is the initial failure of this project a condemnation of smartphone/social media technology for clinical trials or merely a bump in the road for future studies of this type? I would argue that the answer to that question is a little bit of both. Smartphones and other mobile technology devices are here to stay. With the solid technology platform that it provides, I expect that we will see clinical technology companies to leverage that infrastructure to create mobile based data collection solutions for the industry.
However, the Pfizer project did show some of the weaknesses of using this type of technology. In order to maintain regulatory focus, parts of the project were complicated and unwieldy, and turned off trial participants. In addition, subjects were wary about putting their health information online. I personally might argue that the project subject population (older women suffering from urinary incontinence) was probably a poor choice for this pilot project considering that group may not be as technology savvy as needed for the successful conduct of the study. While resolutions to these problems are certainly doable, it does show us the inherent reasons that the clinical trial process has remained so entrenched after all these years – industry controls for the safety of the patient enforce the use of face-to-face interaction between patients and clinical staff to explain the clinical trial process. Patients are put at ease by physicians and nurses explaining things like informed consent, even if they still are not sure what it really means.
That concept, plus the limited guidance provided by the FDA for social media in clinical trials means that the pharma industry will probably continue to move cautiously in using mobile technology for clinical trials for the immediate future. However, by focusing on smaller data collection points, perhaps in conjunction with clinical site supervision, the lure of a stable and reasonably secure mobile technology that millions of potential subjects already possess is too strong to ignore.