Melissa Mooney, director of eCOA Solutions Engineering at IQVIA, explains how successful oncology drug development relies on an accurate depiction of the patient voice, as well as 5 key considerations for developing a patient-centric eCOA strategy.
Key insights:
- Patient reported outcomes (PROs) help enrich understanding of impact of treatments on patient lives, including quality of life.
- Utilising PRO data, from eCOAs, can capture the patient voice without over-burdening the patuent from otherwise repetitive surveys and assessments.
- Remote eCOA data collection provides patients the flexibility to complete assessments from home on days when they cannot make it to site.
When it comes to clinical trials, capturing the patient voice is especially critical for drug development and evaluation. While investigators bring scientific rigor to clinical research, only patients fully understand the impact a treatment has on their lives. Hence, when reviewing oncology treatments, regulators want to see more than just test results and survival metrics. Clinical indications such as tumour size, delayed disease progression, and absence of side effects are excellent measures of a treatment’s impact, but they don’t capture the patient’s experience living with their disease and study treatment – an essential factor when assessing the risks and benefits of a treatment.
Patient reported outcomes (PROs) help enrich understanding of treatments through the lens of the patient, including how symptoms and adverse events impact study medication adherence and quality of life, and how those impacts vary across patient populations. Now that the Food and Drug Administration and European Medicines Agency have advocated for the inclusion of PROs in study protocols, PRO data has also become a significant consideration to payers and providers as they assess the value of an oncology treatment comparative to other options.
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Researchers are becoming increasingly conscious of the frequency, format, and comparability of each assessment they ask a patient to complete, driving the widespread adoption of electronic clinical outcomes assessments (eCOAs). Given that sick patients have limited time and stamina for repetitive surveys and assessments, getting the most out of PRO data requires a strategy that captures the patient voice without over-burdening. eCOAs significantly reduce the patient burden by equipping patients with the flexibility to complete assessments on their own time in the comfort of their own homes, on familiar technology, like a smart phone or tablet. This decentralised approach ultimately amplifies the patient voice and gives clinical sites access to PRO data in between clinic visits, accelerating visibility into patient and trial progression.
In selecting the best assessment for an oncology trial, it is critical to decipher what role the assessment will play in the research, the new knowledge and/or insights it will contribute, and how to best cultivate patient engagement in the assessment process. Here are five recommendations to consider:
1. Think outside the clinic
Both the widespread acceptance of decentralised clinical trials and the focus on patient engagement have expanded elements of the research process beyond the confines of physical trial sites. Investigators should select assessments with this industry shift in mind.
In this sense, the benefit of remote eCOA data collection is twofold – clinicians can collect data from patients between site visits, while also leveraging the same technology to monitor the patient experience from the clinical site. This provides patients the flexibility to complete assessments from home on days when they feel too ill to travel to the site.
2. Prioritise ease of use
Design your eCOA solution to accommodate continuous starts and stops for patients who may be suffering with symptoms limiting their ability to input their responses in one sitting. While spending a few minutes weekly on a survey may seem simple to some, for someone suffering with chronic nausea or weakness it can be extremely overwhelming. Catering the solution design toward participating patients not only improves the patient experience, but also drives adherence to assessment compliance.
3. Consider a 'bring your own device' strategy
One study found that 94% of participants would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Patients are most familiar and comfortable with their own devices. Through a bring your own device (BYOD) model, patients can access all trial communications and alerts on their own device, eliminating the time and cost of commissioning devices for each patient, reducing trial budget, and ultimately accelerating study startup. This approach drives compliance and supports the expanding trend toward decentralisation.
4. Accommodate caregiver assistance
For some patients, completing an eCOA may become too burdensome due to illness, fatigue, or disease progression. To accommodate these difficulties, sponsors can design their assessment to allow a caregiver response entry option, which will allow patients to dictate their responses to their respective caregivers. Some solutions even offer a caregiver log-in feature to ensure full transparency, security, and data entry attribution. Engaging caregivers to assist patients when needed exhibits a clear commitment to patient-centricity.
5. Ensure comprehensive user training
Patient-centricity involves more than just instructing patients and caregivers how to complete the eCOA and use the technology – stakeholders should take this one step further and discuss the value that a completed eCOA adds to the research. Effectively communicating the value of participation increases compliance and overall patient engagement.
Looking to the Future
As the clinical research space becomes increasingly decentralised, the focus on patient-centricity will only continue to evolve. While scientific rigor is an essential component to the success of a clinical trial, researchers must not forget the importance of the patient voice. When an eCOA is designed through the lens of patient-centricity, sponsors will elevate the patient experience, increase compliance, and ultimately accelerate drug development and breakthrough treatments in the oncology space.