The use of wearable technology in clinical trials has the potential to be one of the most disruptive innovations in drug development. The cost and duration of the current clinical trial design has been under scrutiny for a number of years with the sustainability of the exiting model under question. A critical success factor is adequate patient recruitment and retention. Recent initiatives to redesign the clinical trial process have focused on the creation of trials that are more patient focused. A wealth of medical grade physiological data is now readily available from wearable technology, with the potential to create a new future where patients no longer have to visit research sites and where real-time data are available remotely.
However, integrating wearables into a clinical trial is more complex than simply giving the patient a smartwatch and spontaneously generating clinically relevant data. Focusing on technology and sandwiching it into a trial is not a best practice. Wearables need to be viewed as a component of an overall patient-centric strategy rather than solutions in themselves. When creating a remote trial, simply shifting the burden from the sites to the patients, requiring them to carry out a number of tasks in an unsupported, uncontrolled environment is neither welcome nor sustainable. The process for successful selection and integration of wearables needs to take a number of criteria into consideration; clinical hypotheses, the value that is gained by the inclusion of wearables, the robustness of the data generated by the devices, and ensuring that the data adds clarity not additional complexity to the trial.
The re-engineering of the clinical trial to create a patient focused trial goes beyond mere convenience. Wearables and sensor have the potential to generate digital maps of individual's physical behaviours. Wearable technology is facilitating the remote capture of real life data but also has the potential to create new end points and outcome measures that are meaningful to the patient and could hold the key to a new clinical trials paradigm.
Disclosure of Interest None declared
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