Something as simple as details of the normal ranges could be concerning to the patient if, for instance, the normal for that patient happens to not be within the normal range for the general population. While from a medical perspective there are no concerns for that patient, the relaying of such details to the patient requires careful management to avoid the patient misconstruing the information.

With consumer-grade wearables, trial professionals often need to assess how they can ensure data collected from wearables is accurate, considering how difficult it can be to ensure patients keep their consumer wearables charged and in good working order. Additionally, they need to rely on patients to wear their devices correctly and that the data is downloaded correctly and is secure.

It is important that the trial sponsor thinks about what kind of data is needed and why the specific information is being collected. At this stage, considerations should be made regarding the format of the raw data that is provided from the device selected and how the information should be analysed. It is also essential to determine the frequency of data collection. As devices collect data continuously, the question is two-fold. First, assess the granularity of the data available from the device, such as minute-by-minute summaries vs all raw data. Second, determine the expectations around wear time. Determining this ahead of time helps to decide the device selection, eg bring your own device (BYOD), consumer devices or medical-grade device options.

Due to the pandemic, companies see patients as informed collaborators whose participation could be key to furthering the overall success of a trial. Hence the term and greater usage of ‘patient-centric trials’.

There are challenges concerning access to the data, data format, frequency of data extraction and validity of the data. Different types of devices have different challenges in accessing the data, eg BYOD vs medical grade devices. BYOD is playing a more active role in patient-centric clinical trials. If BYOD simplifies the clinical trial process, sponsors may achieve improved patient compliance, higher-quality data and potentially lower operational costs.

Once a device is chosen, it is vital to understand the flow of data, from the extraction of data from the device to the storage of the raw data, of which there is likely to be a lot, through to the summarised data for the trial team. Certain measures should be put in place to ensure the flow is efficient, successful and secure. Deciding who is responsible for different parts of the data flow is vital to ensure the information will disseminate correctly, and with consideration to upgrades and changes by the manufacturers, who will monitor and update the workflow. Therefore, it is important to factor in how this will this impact the final analysis.

Generally, the trial sponsor would determine, with input from the clinicians, if the data collected from wearables will be used during the trial and, if so, how? The rationale for using wearables is assessed at the beginning of the trial and performance is monitored throughout the trial. It is important to factor in whether the trial will require all the data collected such as activity, steps and location information or just certain aspects.

Expectations for the time patients spend wearing the device must also be decided with regard to the need to detect, monitor and/or manage the time the device is not worn during the trial.

Such considerations about whether the clinician should discuss the data from the device with the patient will need to be assessed, as well as which elements are to be included and how. If the patient is expecting to have a discussion, the patient may become disengaged if it doesn’t happen. Additional areas may need to be addressed if device information doesn’t match the information provided from the patient. For example, if a patient reports he or she is walking ten miles a day, but the device only records 1,000 steps, this issue needs to be resolved.

One fundamental challenge for trial teams comes when they need to ensure their patient-level data collected remotely is accurate, complete and in line with applicable regulatory considerations.

Standardising remote data collection across participating sites, trial participants and study visits can reduce variability in the data. Prior to deployment of remote data collection, trial sponsors need to evaluate the feasibility of the remote data collection method. It is vital that trial sites and participants are prepared and fully able to comply with the data collection methods chosen.

Site training may also be required to ensure systematic data collection and the need to uphold patient confidentiality. In lieu of attaining all pertinent information that would normally have been collected during a face-to-face study assessment, a video assessment including the date and time should be included in the study source documents. To pre-empt the potential of missing data during remote monitoring, notification technologies that remind and prompt the patients/participants to report their information should be used.

Research professionals continue to try to balance the need for accuracy, efficiency, thoroughness and other positive aspects in their trials as best as they can, while trying to reduce the patient burden. The more unobtrusive the trial, the more favourable it will be for patients and the clinical site. Spreading out the assessments, for example, and decreasing the number of assessments performed at each visit is something sponsors may want to consider. Using verbal and/or electronic reminders in patient reporting can be helpful and it could reduce the amount of missed assessments/reporting and provide a better outcome. Providing training for those working at clinical sites about how to efficiently capture study data remotely could be a worthwhile investment.

The advent of decentralised or remote clinical trials has created both challenges and opportunities for accurate data collection. With efficient processes in place, it has been proven possible to ensure data flow is accurate, successful and secure. Clearly, the expansion of telemedicine approaches with patients off-site has created an opportunity for both mitigating patient risks in a face-to-face setting as well as allowing patients a more comfortable setting in which to deliver data to clinicians during a trial.

It’s still uncertain if consumer wearables will ever gain the credibility, or even functionality, of medical-grade devices, but as wearables (consumer, clinical grade and BYOD) continue to gain traction they, along with telemedicine approaches, may become another important asset in closing some of healthcare’s considerable communications gaps.

Jennifer Bradford is Director of Data Science and Sheelagh Aird is Senior Director of Clinical Data Operations, both at PHASTAR, www.phastar.com