Rachael Wyllie, CEO, shares her perspectives on eCOA Trends in 2016
Q: What are some of the major factors that will be shaping the eCOA market over the next 12 months?
Rachael Wyllie: I think it will be a mixture of things. I think there will be greater emphasis on specific therapeutic areas that are being developed. Obviously there’s a huge interest in oncology at the moment, and oncology quality of life is very important. I think the recent trend of interest in Alzheimer’s disease, and new and different ways of treating it and measuring the results will drive a big increase in that therapeutic area as well. There’s also a growing interest in site-based assessments that measure how patients are doing, their quality of life, how they can move around, and how they can continue their normal activities of daily living. We’ve seen a significant growth in that and suspect to see it continue. I think we’ll also see interest in other areas - smaller studies, smaller numbers of patients using them, and into different phases of study as well.
Then there is the growing interest in things like wearables and other sources of data, such as activity meters, temperature, oximeters, and a whole plethora of different devices that can add both color and quality to the data that’s captured. We'll see those devices starting to be used more widely adding more insight into the data being collected. BYOD may also impact the market, but possibly not in 2016. That may be a little bit further out!
Q: What are some of the trends currently taking place within the eCOA market and what do you foresee as some of the future developments for eCOA?
RW: I think it’s a little bit about what I talked about above, and the mixing of more objective data in with the subjective data. I think the other piece that’s happening is much higher volumes of data, for instance continuous blood glucose monitoring or continuous activity monitoring rather than just taking snapshots of data. I think more and more is being done in that area, and it will give much better data back to the pharma and help them develop better drugs, although at this time many stakeholders are still working to determine the best ways in which to leverage these higher volumes of data.
We’re seeing a lot more studies using eCOA and the use of more site-based instruments. When I think about the reasons for this the biopharma Sponsors are now realizing and more significantly embracing that the fact that it's actually more beneficial and cost effective to do it electronically, with better quality and control of the data.
Q: Can you describe the challenges still facing organizations in the adoption of eCOA?
RW: I think, the biggest challenge is that there’s a lack of standards, and it’s done sort of piecemeal, team by team. Therefore they don’t invest in the knowledge of how to work with vendors; how to not repeat the same mistakes or make extra work. I think that’s probably the biggest challenge people have when they first adopt eCOA, and then understanding what you can and can’t do with source data. People are so used to copies of data, or transcribed data - it’s very different in a source data environment. Getting a really good understanding of the regulations that are relevant, what you can and can’t do, is very critical. Another challenge is translating into multiple languages; this can be a challenge on paper as well as electronically.
Also there’s lots of talk about BYOD or "Bring Your Own Device". We are seeing some adoption of BYOD with our technologies. The opportunity and the technology is there to do it. The problems with it are really more operational than technical, for instance, whether patients have the right phone or are willing to use their own phone. Even if both of those are true, the logistics of supplying phones for patients who do not have one is quite challenging.
Rachael Wyllie has a background in pharmaceutical research and information technology with nearly 20 years of electronic clinical outcome assessment (eCOA) and electronic data capture (EDC) experience.
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