International Clinical Trials chats with Julia Lakeland about her career path and how eCOA/ePRO platforms have developed over the years
An article by International Clinical Trials | Patience with Patients: Julia Lakeland
What have you found to be your biggest motivations during your career and what continues to motivate you now?
What motivates me is that what we do makes a genuine difference. When working in this space, it’s easy to see how the world around you is changing, especially the digital landscape and its human aspect. Being a parent and getting older, it makes it even more apparent that our bodies are precious and valuable, and actually having the ability to bring new drugs to market makes the work much more meaningful. That’s what has kept me going for all these years and that’s why I have never left. It’s a small industry and you can move around to different companies – but nobody really strays far from it, not once you get to a point where you are aware of what a difference you can make. It’s exciting!
I can genuinely say that I have never thought this industry was not for me. Acknowledging that everybody’s individual and that everybody has something that may not be going their way, whether it’s a mental health issue or a therapeutic one – it’s that human aspect that means so much to me, and that’s why I enjoy working at uMotif where there’s a constant emphasis on the patient across all we do. As an industry, there’s still so much more we can do, but the fact we’re on a journey to better patient engagement is also quite exciting. Just look at the last three to four years, for instance, and how much decentralised clinical trials (DCTs) have grown and the massive growth of digitalisation across the industry. Patients want to learn and they have the ability to learn as the internet is at their fingertips, accelerating the speed at which patient engagement can occur.
How do you feel the patient experience in clinical research has evolved over the last several years?
The focus on the patient is more prevalent now than it ever has been. The COVID-19 pandemic is something that none of us will ever want to go through again, but it did force a change in the industry, which facilitated increased patient focus, as it highlighted certain ways of how we conducted research.
As an industry, because we had these conceptual ideas around DCTs, siteless trials and virtual trials, as well as the journey of the patient, we were able to pivot. When I look at the journey on what matters to the patient, if you put good data in, you’ll get good data back. The biggest challenges for us as an industry are in recruitment, retention and engagement, which haven’t changed in the last 25 years. But now we have the ability to have DCTs and the digital technology that enables this, which gives you flexibility. I think that flexibility is what’s most important because there are going to be times where, as a patient, you need to go to hospital. You need to be seen; you need to have face-to-face visits. But there are certain populations that can’t get to the site easily.
There is a lot more work to be done, but the technology is there for us to take advantage of and I think that’s where the voice of the patient and everything around how we conduct research has got to be our main focus, which has started to come through.
Do you think there’s any other way of engaging with ePRO for those with visual disabilities or those who aren’t able to access the internet or don’t have the technology required?
It doesn’t have to be complicated – ideally we can have audio and voice memos and Braille, for example. But, it’s just being mindful of the industry that we are part of, the regulations that we have to abide within, the data that we have to submit, and it’s not always easy to implement new technology. But there are so many tools at our fingertips in order to conduct questionnaires and research, and having a caregiver associated with the patient, to answer the data on behalf of them, is one of those approaches.
I think we have got to be realistic about how we address these challenges, because patient safety is always most important and that’s where we need to get to. For our industry, there are ways to get around the restrictions and challenges of patient safety, validity and reliability of the data. Sometimes we just need to have a toolkit available at our fingertips that you can draw upon.
ePRO was designed by patients for patients. Can you give us a bit more in-depth information about the programme?
I do think that too few trials start with the voice of the patient. Protocols are built around endpoints and measurements – what’s the expected outcome? uMotif and our technology started with the voice of the patient. This was the vision since the beginning after the realisation that there was an opportunity to deliver a great experience to patients who wanted to give their data to research, which is what differentiates our technology. We look at it through a different lens and we acknowledge that the data has to be aggregated or analysed, and that it needs to meet the endpoints of the protocol 100%. However, there is still a gap in patients who sign up for research and we saw that gap during COVID-19. People have to trust the technology. It has to be easy to use. As a patient, you’re taking your valuable time and you’re giving something to science. And so, the ease of use and the recognition that each patient is different, and that they have different expectations, is vital.
As a technology provider, and a provider of clinical solutions and eClinical solutions, I recognise that and that’s what makes modern eCOA so different. You have configurability to adapt to the phase of the trial and to the needs of the patient – you can offer that toolkit to not only capture meaningful data, but to engage the patient and recognise each person’s individuality.
What common misconceptions do sponsors, CROs and others in the industry have about eCOA/ePRO technology?
I think there’s a host of misconceptions. I hear that the feedback from paper-based questionnaires is insufficient; that eCOA is too complex to implement; that timelines can be long; that translations are complicated; that there are ethics approvals to get through. As an eCOA provider and expert in this area, the industry and providers have learnt that all of these hurdles can be overcome.
An area of focus that I would like to see come through is the use of Bring Your Own Device (BYOD), especially within phase 2 and phase 3 trials. The question of whether BYOD is acceptable to regulators comes with a misconception that you have to have provision devices. As an engagement mechanism, if you’re engaging a patient with an app on a provisioned device and they have not got the device with them, it’s not an effective strategy. From our perspective of BYOD, we have native questionnaires so the content can be rendered according to the screen size and the input blocks that are needed. Those restrictions that we had previously aren’t there anymore. So, as far as app development is concerned, and looking at the reliability of the data and how the questionnaires have surfaced, all of that is fully addressed with a BYOD nowadays, along with patient convenience.
There is a misconception that the use of BYOD, and the resulting data, is not accepted, but there’s a lot of research available here that points to BYOD being a growing trend. I think one idea is that, because the questionnaires are on paper, they are easy to do, but that they are not as easy on an electronic device. When you have paper-based questionnaires you can have a flow with skippable sections and the ability to loop back, but with electronic devices, it’s harder to do that and you may need to branch off and repeat. So, there are complexities and I think people have an idea that eCOA can’t handle the questionnaires. However, the technology is there and all we’re doing as technologists is pulling in what we’ve learned in order to reveal and address those needs.
The other misconception is with timelines and the time it takes to translate the information. Again, that’s not the case. Nowadays, eCOA takes no longer to implement than an IRT or any other eClinical system: this has been tried and tested. Having a clear eCOA strategy upfront to support your study is really the way to go to overcome any hurdles that you can encounter along the way.
“The voice of the patient is so important and it weaves into your study design, because the data you capture is invaluable to support both your endpoints and medicine development”
We acknowledge that our industry is not always quick to adopt new concepts. Yes, there are considerations around conducting a global trial and local infrastructure, but there should be few challenges nowadays around the adoption of new technology. I would love to see patient engagement in some form of ePRO or eCOA in every study. The voice of the patient is so important and it weaves into your study design, because the data you capture is invaluable to support both your endpoints and medicine development.
Which trends in eClinical technology do you feel that sponsors and CROs should learn more about?
The inclusion of wearable and medical devices for scientific purposes – this is other area that I am highly passionate about. My daughter is a type 1 diabetic, and ten years ago we had an insulin pump. Seven years ago, we had a continuous glucose monitor (CGM). Three years ago, we had a CGM that I could monitor remotely. Two years ago, she was given a closed loop. Technology in our industry makes such a difference to patients, to parents, to family members and to science.
Medical devices allow you to look for digital and novel endpoints and allow us to understand more about where the data is coming from. A highly experienced cardiologist once said to me that an a good indication that a drug is working is reflected in the patient’s health and well-being. If they are active and sleeping, then they are feeling better and the drug is most likely working. Those words have resonated with me and I take them everywhere. So, when I think about eCOA, you can capture that subjective data with wearables. There are devices available that are not intrusive and focus on patient comfort, that have a valid clinical standard and a reliable data flow. That’s where I would love to see us moving towards, and I think that’s where we can continue to really push boundaries now.
There is basic vital sign monitoring that can be done within the home, such as taking your blood pressure or having a digital scale to monitor your weight. It’s just making sure that the device is being used appropriately so that you can monitor the data flow and look for irregularities or challenges that need to be addressed.
Of course, there are some problems – you can’t always assume that somebody is going to use the device as intended – but patients want to be empowered. They want to know what’s happening and I appreciate that with scientific research you have to blind certain results and you don’t want to introduce bias, but you need to find a happy medium. I think a lot of these devices are ready to be used at home – they are not complicated to use and they are readily available. Just look at how diabetes care has vastly improved over the last decade – it’s exciting to think about what else can we learn from here!