CamNtech gets an FDA nod as wearable devices advance into clinical trials

Clinical trial data collection has evolved slowly over the past two decades from site visits and paper questionnaires to telemedicine and electronic patient reported outcomes (ePRO). The transition is far from complete though, with the likes of CamNtech and Medidata ($MDSO) now looking to bring wearable computers to clinical trials.

United Kingdom-based CamNtech is working on such technology and recently received FDA approval for two of its devices, MotionWatch and PRO-Diary. Both are wristwatch-like devices that contain tri-axis accelerometer sensors to measure the wearer's level of physical activity. PRO-Diary also has ePRO capabilities. Trial participants wearing the PRO-Diary receive prompts to answer questions using the device's screen at specific times.

Having trial participants wear an ePRO device could overcome long-standing problems of paper and electronic questionnaires. When using paper, some patients wait until just before a trial site visit to complete their form. Similarly, patients can forget to carry a dedicated ePRO device at all times. In both scenarios patients aren't entering information about how they are feeling in real time, introducing the risk of recall bias.

While an ePRO wristband goes some way to avoiding this bias it still requires patients to wear an extra device. With many trial participants already carrying smartphones that can perform health tracking functions--and Apple ($AAPL) reportedly looking to expand such capabilities--there is interest in seeing bring your own device (BYOD) enter clinical trials. Allowing participants to use their own smartphones would free them of the need to carry an extra, unfamiliar device for data entry.

Regulatory obstacles must be overcome first, but there is a clear interest in expanding the range of ways in which trials collect data. Medidata is already testing mHealth tracking devices from Withings, and software engineers have linked FitBit and Nike Fuelband to its data capture system. In an interview with Forbes, Medidata's co-founders reference the use of wearable devices as one way in which the company is expanding its role in clinical trials.

- here's the CamNtech approval (PDF)
- read MobiHealthNews' take
- check out the Forbes feature