The Next Big Thing in Clinical Research: Patient-Centered Trials

Pfizer recently announced its plans to use eDiary technology in the first ever Participatory Patient-Centered (PPC) clinical trial. The pilot seeks to replicate the results of a previous study for the treatment of overactive bladder.

Successful replication will validate the PPC approach of using mobile technology to enable patients to participate in a trial regardless of age or location.

Increased patient enrollment and retention is not the only benefit of this approach. Real-time data capture directly from the patient allows investigators to react quickly to extraordinary symptoms that could adversely affect the patient's safety. Remote data reporting by the patient also has the potential for significant savings by cutting down on costly site management and reducing the time investigators must invest in a trial from end to end.

Here is an example where today's digital capabilities go beyond enabling simplification and convenience in this industry and actually work to transform the model for clinical trial performance. The metrics by which trial sponsors and CROs measure their performance - cycle times, enrollment targets, adherence to protocol, and so on - can be directly and positively impacted by empowering patients to take a more active role in the trial management process. Data capture is instant and can be kept in check with friendly patient reminders - or text message proompts, in the case of Pfizer's trial. Sponsors might actually begin to measure trial performance based on outcomes-based indicators, rather than on intermediate targets.

Overall, the speed and quality with which clinical trials are run is the biggest win with the use of eDiary technology - not just the ability to reach a larger audience.

In related recent news, social network site PatientsLikeMe has demonstrated a successful "social study" for ALS in which patients were enrolled, data was collected, and preliminary results were presented in just nine short months. Read more about the potential impacts of social media on clinical trials here.