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Electronic data collection has grown rapidly over the course of the last ten years.
Electronic data collection has grown rapidly over the course of the last ten years and has already emerged as a common asset in clinical research for the completion of Clinical Outcome Assessments (COA), including the outcomes captured directly from patients, known as patient reported outcomes (PRO). The global growth of mobile technology over recent years has provided a new and efficient method of accessing patients, creating an ideal platform for capturing eCOA assessments.
At its core, mobile technology is able to support the diaries, scales and questionnaires required for capture of PROs during trials, however the advantage mobile ePRO holds over paper and other types of ePRO devices lies in the provision of a simple intuitive interface for patients, that facilitates the 2-way communication so important to keeping patients engaged including educational and motivational content delivered via messaging and in-app notifications throughout their participation in a clinical trial.
The use of mobile ePRO is now becoming commonplace, and the barriers to adoption have been broken down through the incorporation of data security measures to protect patient data, the validation of a huge range of instruments from paper entry to mobile, and the reassurance of regulatory acceptability – both through public statements such as comment last year from the FDA that the “BYOD (bring your own device) approach does not contravene 21 CFR Part 11”* and, perhaps more substantially, the use of mobile ePRO to collect primary outcomes data in numerous product approvals in Europe and the USA.
The move away from ePRO device provisioning and towards a BYOD approach (where patients use their own mobile devices) is currently a topic of hot debate. For me, part of the cause of this debate is the mistaken belief that when introducing BYOD into a protocol, enrollment of patients with a specific type of device is the only option. That approach would be offering choice in the same way that Henry Ford did to the choice of color for his Model T car – you can bring any device to this study, as long as it’s an android with Ice Cream version12.2 OS – this clearly isn’t practical as it would seriously limit study eligibility criteria.
As the only vendor with tangible experience in this field, the reality of BYOD in clinical trials is very different. We have been providing ePRO solutions for BYOD trials for many years and almost always introduce an element of provisioning in pre-approval studies. The key is to be able to identify the specifications of the patient’s device and ascertain whether it meets the requirements for the individual study, if not then a suitable device can be provisioned. I like to think of it being a flexible or ‘choice driven’ approach. The provisioning rate for such studies is decreasing year-on-year as the uptake of more advanced mobile technology increases (did you know in the US almost ¾ of adults over 65 now own a mobile phone?**) and in pre-approval studies we see rates anywhere from about 50% provisioned down to as low as 10%, depending on the study population. This provides 2 significant benefits, not only does it enable the patient to use their own device, the one they selected from all available options, but it significantly reduces the cost and logistical complexity of device provisioning for sponsors.
I set out 10 years ago to simplify the process of collecting patient data during clinical trials through the use of mobile technology. I couldn’t have predicted back then just how far mobile technology would advance and how it would become such an integral part of daily life for people around the world. Now mobile eCOA is proven to be a highly beneficial and versatile option for data capture in clinical trials. It has been shown to significantly improve data quality of PROs and has been used – both through a provisioning and a BYOD approach – to collect primary outcomes data in Europe and US drug approvals. I believe mobile is set for further expansion and growth as the industry escalates the adoption of existing mobile ePRO as the standard approach to self-reported clinical data.
* Panel session at MCT Congress 2014