I've started collecting information regarding the key barriers for eCOA (electronic Clinical Outcome Assessments) adoption from the perspective of new (or potential) users. In many cases we on the eCOA service provider side might not even be fully aware of all of them, perhaps because we have worked out solutions to most of the key concerns. But if we're not aware of the user's concerns, we might never get the opportunity to address them.
Quite often we end up working with expert users from the client side who see the value in using eCOA within their company and they're asking for our help to provide justification to the rest of their organization as well. I can imagine there are a wide variety of reasons and it's impossible to address all of them in a blog post. But I think this may be a good format to address some of the key recurring ones.
Barrier 1 - Perceived High Cost of eCOA
Naturally, companies need to understand whether it is worth investing in eCOA technology for their particular need. In order to do this they first need to understand the additional cost for introducing this technology. This step is fairly easy as eCOA costs are highly transparent, up-front and at least with CRF Health, fixed scope = fixed cost. There are pros and cons to this transparency in pricing; the eCOA price sticker is highly visible, but the paper one is not. It can be very difficult to estimate costs for paper studies, because most of the costs come from processing the paper into electronic format and cleaning it, and these costs are often 'hidden' behind the hours spent on it by study sites and data management. However, this is still something that can be measured and estimated to some degree of accuracy when effort is put into it.
The other aspect of ROI is the expected benefits of the technology. This can be very difficult to quantify in terms of money. eCOA technology can have a huge impact on the quality of the data, regulatory acceptance and the management of the study. There are examples from studies where patients reported more 'events' using eCOA than paper. In some cases, there have been 2-3 times more events reported with eCOA than with equivalent studies using paper. Many study designs ultimately require a certain number of 'events' to occur or data points to be collected in order to be able to demonstrate efficacy or safety. If the use of eCOA collects more of these events faster, does that mean that the study may get by with fewer patients? Perhaps so, if these factors are well understood and the use of eCOA is considered early on, in order to take this into account in the protocol design. Another factor that is based on evidence in studies is that the use of eCOA can help retain patients. This can be seen from decreased screening failure rates and rates of withdrawal of consent and in the high levels of compliance for data entry. Recruiting patients is expensive and time consuming and losing them in the middle of the study is even more expensive.
With eCOA the site staff can monitor the patients remotely and make sure they're compliant with the study medication and data entry schedules, providing a benefit for real-time management of patients between visits. Quite a few investigative products are highly dependent on the patients being able to closely follow the medication regimen, including concomitant medications. eCOA can help a great deal by guiding the patients as well as reporting any deviations to the sites immediately. But what is the impact of all this? I would expect it's far easier to demonstrate efficacy of a drug when it's used as instructed.
Then there are adaptive protocols, which are dependent on getting early results from the study and then using this information to drive decisions on how to proceed. Having trustworthy, clean data available in real time must be of great value, but how do you assign a dollar figure to that?
This is a topic I will continue working with and is probably important enough to warrant its own blog post later on ...
Barrier 2 - Can the Patients Use It?
This comes up a lot and the ever-increasing amount of consumer technology is not always helping. I'm somewhat of a technology expert, but I sometimes have difficulties navigating the menus of my TV. How do you then expect elderly patients who are very ill to be able to use a smartphone device to collect data?
I would split my answer into three parts:
Part 1: Consumer technology IS complicated; it is a very competitive environment with more features and options added all the time, which makes the underlying design principles completely different from those for designing an eCOA instrument. The CRF Health eCOA design principle is to create designs that really guide the user through what they need to do every time they log in. We don't expect them to remember anything from the training or user manual, the eCOA tool will walk them through it, every time they log in.
Part 2: eCOA instruments are created to be better fit for their purposes in clinical trials than your average consumer product. There is plenty of evidence to prove this point. All CRF Health's eCOA tools automatically collect compliance data from our studies. Some of these metrics are interesting: the elderly group has 92.5% compliance, well above the average of 90%. Very interestingly, they also have a relatively low standard deviation of 14.0, compared to 18.9 with the adult group. In fact, it is the adult group that is performing the worst, even though they are the group most used to adopting consumer technology. We have also done several usability studies and focus group sessions and an overwhelming majority of subjects have expressed their preference for electronic data collection over paper.
Part 3: Despite my personal beliefs and the data we have available, each study population and protocol is different. However, there are ways to confirm whether eCOA is a good fit for your study. CRF Health's technology allows us to create eCOA prototypes very rapidly and these can then be deployed to study sites very rapidly for a quick proof-of-concept kind of testing before committing to using the technology on a larger scale. We have done this several times with some tricky conditions such as Parkinson's Disease and Multiple Sclerosis, and I have been quite surprised by the good results we've achieved. I can really recommend this as an objective assessment of the technology in your specific setting. It's also a great way to get some of the key opinion leaders on board and get some early input from them.
Barrier 3 - Lack of Awareness
We interact most often with people who are well aware of eCOA and I've been under the impression that eCOA awareness is well dissipated into the organizations and that study teams are making informed decisions about what modality to use in their study. Apparently that is often not the case and this is clear to see especially when we are asked to attend 'eCOA awareness days' organized by sponsors. In these events, we get to present and do demos for study teams and anyone who's interested. A large portion of the audience is often only slightly aware of the technology, but not the full capabilities and how their particular studies could benefit from it. These sessions have been very useful for us and clearly for our customers as well, because usually after these sessions we start seeing more questions and requests for proposal from those study teams. If you're one of the eCOA champions at your company, I would encourage you to organize more of these kinds of sessions. We are more than happy to support you in this by providing materials, presentations, demos or whatever you need to promote awareness within your company. I would also encourage you to share this blog with your colleagues and refer them to our webinars and archives - there is a lot of useful information available!
Other Barriers - Maybe Something More Specific to You?
Well, I promised to give you a short list of the more common ones. I bet there are a whole host of different ones, perhaps more specific to your situation. You're in luck, because this is going to be one of the topics for CRF Health's next eCOA Forum (used to be called the User Group) in Amsterdam this September. In this interactive workshop, we will have some expert users available to discuss how they've solved some of these challenges and any of our new (or old) users can provide their issues and challenges for discussion facilitated by some of CRF Health's experts and more importantly, our expert users. If you'd like to participate, you can contact me directly at firstname.lastname@example.org. Hope to see you there!
Senior Director, Technical Support, CRF Health