In this blog, Jonathan Pritchard, Director Business Development at Cytel, draws on his experience in commercial, clinical and technology roles within the biopharmaceutical industry and shares his insights on the primary considerations for sponsors when implementing an ePRO solution.
ECOA and ePRO
The field of Electronic Clinical Outcome Assessments ( eCOA) encompasses clinician reported, caregiver reported, or patient-reported outcomes to assess and evaluate the patient experience. Electronic patient-reported outcomes ( ePRO) as part of this broader umbrella, are essentially a validated set of questionnaires that are given to patients to assess subjective experiences; for example their experience of pain, their mood, whether they feel that they can walk a longer distance, climb higher sets of stairs etc.
In recent years, the entire field of ECOA has significantly matured. Initially, we used paper-based surveys. As technology has progressed and evolved, we are now able to deploy sleek applications on the patient’s own smartphone or a device provided by the eCOA provider. Nowadays, we can connect other data sources, such as wearables, photo sensors, diabetes monitors, and glucose monitors to collect the data on an ongoing, real-time basis.
With many trials now incorporating ePRO, let's walk through three critical considerations for sponsors when implementing these solutions into their trials.
Patientricity is essential to successful ePRO implementation, and there needs to be careful consideration of how much data the patient is required to complete, and the consequent burden this may place on them. If data entry is going to require an hour of the patient’s time each day, this will not be practical as required. Therefore the ePRO needs to be designed and implemented in as succinct and non-intrusive fashion as possible. Sponsors also need to be mindful of the specific issues and limitations that particular patient groups such as the elderly, or those with neurological conditions may have. Any such restrictions should inform the choice of solution and the data that is captured. Nowadays, advances in technology such as the availability of wearable sensors mean that we are now able to capture the required data with minimal intrusion on the patient’s day to day life.
The decision as to whether to choose a Bring Your Own Device ( BYOD) model or use a distribution platform is fundamental. The key advantage of using a standard distribution model is that you know that all patients are getting precisely the same device. Technical support is, of course, more straightforward when all subjects are using one platform, and if devices fail, it's easier to manage because you'll have a spare stock that you can ship to the patient. Having this stock readily available reduces patient downtime.
One key advantage of BYOD is network connectivity as the patient will likely have chosen a device with a network that does have a reliable signal in their area. The patient will also be more familiar with their device, and better able to independently resolve any issues.
Of course, with a BYOD model, there is the advantage of not needing to factor in the cost of the devices themselves since patients are using property that they already own. On the other hand, it could lead to delays if for any reason the patient's device is lost or damaged. As sponsors won't reimburse for personal equipment, there could be a lag while it is repaired or replaced. It's important to note that BYOD works exceptionally well for large, post-marketing trials because of the more significant numbers of subjects involved. In a post-marketing context, the collected information is not used for labeling claims and therefore not as rigorously assessed.
Accessing and Viewing the ePRO data
ePRO data needs to be well integrated into the eCRF and EDC systems, so having a data services partner with established processes ensures that you have the reports you need available at your fingertips. The set-up and accessibility of these reports are key because by the time you are deep in a Phase 3 trial, the volume of data becomes substantial and results could be coming in daily. Being able to derive instream insights from this data as it comes in is extremely valuable.
The Future of ePRO
Increasingly we are seeing other sources of real-world data being integrated into the ePRO and eCOA landscape. The new Apple watch, for example, is FDA-approved and has an ECG application available to detect arrhythmias. This application is not clinical- grade, but it can provide useful trends. In the future, I expect that these widely accessible applications will become integrated with eCOA devices and ECOA trials. Ultimately, the patient's device will act as a hub to gather all of this data. In parallel, the in-clinic PROs are also becoming smarter and easier to use.
The real area of future opportunity is maximizing the use of the diverse data collected by eCOA devices. We currently use this data to validate our claims and meet the endpoints within our clinical trials and our protocols. However, we are not yet unlocking this data's full potential. What valuable insights could we find in the hundreds of thousands of data points that are collected during the course of any clinical trial?
As the industry continues to evolve its real-world analytics capabilities, new avenues of opportunity will open up to researchers by generating evidence from patient outcomes data. We will start to increase our understanding of the real effects of how the patient is coping in a real world environment through the direct input of data and the further analysis of this to convert into information and knowledge.
Cytel’s data management team has partnerships with a range of eCOA and ePRO solutions and is adept at advising on the best data collection approach for any given clinical trial.
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About the Author
Jonathan Pritchard, B.Sc is a Business Development Director at Cytel. He has more than 13 years' experience in the delivery and support of clinical trials. At Cytel, his responsibilities include helping to promote the Cytel brand, and providing support to our customers throughout the lifetime of their studies. Prior to joining Cytel, Jonathan served as a Head of Business Development for a Respiratory vendor. His skills include project management, product design, eCOA, proposal generation, business development and account management.
Jonathan attended Canterbury University and received a B.Sc. in Cell and Molecular Biology.