As clinical outcome assessment experts decide the best means for introducing electronic techniques to their field, Simon Wilson of ArisGlobal, software specialists for the life sciences industry, describes how 'bring your own device' (BYOD) can offer an inexpensive and easily implemented option.
In recent months, sponsor, vendor and regulator attitudes towards the concept of bring your own device (BYOD) in electronic clinical outcome assessment (eCOA) have evolved further, with new light being shed on validation barriers.
eCOA data collection often relies upon the use of a validated instrument - a rating scale for example. Rapid advances in technology have changed the landscape of how sponsors collect clinical outcome assessment (COA) data. There has been a rapid move from paper COA data collection to wider use of electronic diaries, rating scales and the like, resulting in quicker data collection with greater accuracy, enhanced data completion and improved subject/rater compliance. However, despite the rise of eCOA, there are still challenges existing in the industry with regard to maximising its potential.
One of the barriers to a more cost-effective use of eCOA is the provisioning of hardware to subjects across multiple geographies. The complexities and costs of sourcing and distributing handsets to subjects are multiplied when numerous country-specific mobile-data-network arrangements are considered.
In many locations, the uptake of smartphones among subject populations is high; for some time now, the proposed solution to these issues has been for subjects to use their own devices to access web-based interfaces or native apps - that is to say either or both 'flavours' of BYOD.
One of the remaining hurdles for BYOD is the lack of validation of instruments across a plethora of devices, operating systems, screen sizes and types. The concern here is that with the wide variety of smartphones out there in the market, there may be inconsistencies in how the data is entered, captured and validated.
It could be argued that a huge assumption has been made on the impact of this 'validation gap'. Clearly, there is a need to ensure that patient-outcomes data collected across a range of handsets is comparable, but is it really necessary to validate data on all handsets to achieve this end? Would it be more effective to collect data in this manner on the assumption that the data collected across a range of handsets is already comparable?
Although the industry operates in a highly regulated, and therefore conservative, environment, regulators tend to support pragmatic solutions to achieve the collection of usable clinical trial data. Recently there have been meta-analyses, published and soon to be published, of aggregated study data that demonstrate the equivalence of instruments across devices.
Regulators are actively seeking advice from experts in the field and formal and informal discussions with regulators continue, such that a broad understanding can develop on the use of BYOD for eCOA. Debate continues in the community on how to proceed. One thing seems certain - it is no longer a question of whether eCOA will be available on BYOD, but when.
The clinical trials industry is on the cusp of a revolution in COA. Once acceptance of BYOD for eCOA becomes widespread, there will be a dramatic increase in the use of technology with all the benefits of timely and accurate data collection, and the subject compliance this brings.
Perhaps it's time to challenge the status quo. One well designed, co-funded study might open the door to a whole new world of potential - the super-cheap, rapidly established and easily managed collection of patient outcomes data. Such a study would set out to disprove the negative hypothesis, that COA data collected on one instrument across multiple handsets is not comparable.
There are still challenges, including security concerns, reimbursements to subjects and comparability of results across multiple devices. Of course, the socioeconomic issue of potentially excluding subjects without access to a smartphone must not be neglected, and perhaps this calls for the creation of hybrid BYOD and paper studies. These are all topics for further discussion as developments continue in what is undoubtedly a very important area for clinical studies.
References are available upon request.