2019-08-23
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Data from smartwatches, activity trackers, sleep and heart rate monitors and other wearable devices are being incorporated into clinical trial methodology more and more frequently. Patients, sponsors and other stakeholders are increasingly recognising their advantages, including better understanding of a participant and the effectiveness of different treatments.

Data collected can provide valuable insight into a patient’s health and their engagement within the study. Patients themselves may have access to life metrics they would not otherwise be aware of.

The possibilities for research within pharmaceuticals are potentially endless, especially as existing products mature and additional ones make their way into the markets. The integration of a variety of data streams will provide a much deeper and more valuable insight into patient experience, as part of clinical trials.

As with anything, however, there are some considerations, which clinical trial services will always bear in mind, prior to the introduction of wearables into a clinical trial.

If you want to take part in a trial there are Patient Recruitment Services out there which you might find on the internet for instance https://www.richmondpharmacology.com/specialist-services/patient-recruitment. Its so well organised they have 250,000 willing volunteers registered and pre-qualified to do clinical trials.

Scientific considerations

In order for data collected through the use of wearables to be reliable, the devices themselves must be:

Fit for purpose – Scientific questions must be driven by the trial’s endpoints and not by the choice of wearables available.

In context – Data collected, including activity levels, sleep patterns and heart rates, is only meaningful in the context in which the data has been collected.

Validated and accurate – Some devices may not have been subject to the same standards of accuracy as other medical devices, especially those developed primarily for commercial use.

Operational considerations

Alongside the scientific considerations outlined above, there are also some operational considerations,

Wearable goals – before even looking at the different devices available, sponsors must first decide what data is required. By having a very specific idea of this, the scope can be considerably narrowed.

Selection – Most people think of activity meters when referring to wearables. However, there are many different types of wearable device, including those which have multiple sensors and/or use patches. As technology improves, new innovations are being brought to market all the time, so finding the most fit for purpose design is likely to become easier and easier.

Patient experience – An uncomfortable device could impact the reliability of data collected, through loss of data or non-compliance.

Paul La'Hay

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