Some believe that the growing availability and popularity of wearable devices for collecting health data could point to the next revolution in clinical operations. Advocates of using wearable devices in clinical trials suggest that the technology has a host of potential benefits if harnessed correctly, including the collection of health data in real-time, greater patient engagement and increasing operational efficiency leading to shorter trial timelines. Perhaps unsurprisingly it has been the larger pharmaceutical companies who have provided the early test cases for this technology even though it could, in theory, have cost-saving benefits for companies of all sizes. However, there remain a number of challenges to overcome when considering utilizing wearable devices in your clinical trials, even for those organizations that have bigger budgets to play with.
Data Flow
One of the main concerns of those considering integrating wearable devices and other technology (such as smart phones) into a trial is the data flow between the different technologies. Where accuracy of data is concerned, it is essential that the trial sponsor can be sure that data can be collated from all of the technology involved (smart phone, wearable device, app, etc) and equally that the technology can link up with IVRS (interactive voice response system), EDC (electronic data capture) and other systems. However, this is not the main problem because collecting a wealth of data on the trial participant should be a fairly easy process. What most biopharma companies are still grappling with is how to analyze this data effectively and turn it into meaningful action. This is why it is absolutely essential that biopharma companies find a data analysis partner before trial start-up so they can make the most of the data gained from new technology in clinical trials.
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Patient Demographics
One of the benefits of wearable technology in trials is greater patient engagement. Wearables and smart phones can be an unobtrusive way to gain key data from patients remotely throughout the trial process. However, biopharma companies must also consider the pitfalls of these technologies for patients. Not all of your trial subjects may be equally tech-savvy. Incorrect use of the technology could result in poor data so it is important that all patients receive proper training. Another strategy is to factor in a test period before the trial officially begins in order to ensure that patients are accurately recording data through the technology and mitigate the risk of errors later during the trial itself. It is equally important to have a process in place for those patients who simply cannot and prefer not to use the technology on offer.
Finding the Right Technology
All trials are not made equal and despite the wealth of technology on the market finding the right fit for your purpose remains a challenge. More CROs are now offering the option of integrating new technologies into trials and more surely will as the market demand increases. Equally, there are many small start-up companies that might offer the specialized technology that you need for your specific trial but if you are working across multiple sites in different geographic regions then you will need to consider if this technology can be scaled-up quickly (and who will fund this).
Where is the Real Value?
It may be tempting to jump on the bandwagon of something as innovative and potentially beneficial as wearable devices and smart technology in clinical trials but we also need to question where the real value lies in these technologies. There is at the moment a tension between the traditional clinical trial design and the opportunities offered by new trial technologies. Perhaps the real revolution for clinical operations will come when new technologies are integrated with innovative trial designs. By working closely with both CROs and technology companies, trial sponsors have the opportunity to think differently about trial designs and find new ways to engage patients while also saving costs and shortening timelines. New technology may enable the revolution in clinical operations but true change will rely on the creativity showcased by individuals.
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