Times are changing. Patients considering clinical trials as a care option are looking for experiences that make room for the other responsibilities and interests in their lives. At the same time, sponsors and site teams know they need to reach more diverse groups of patients if they want to produce conclusive safety and efficacy data. This means they need to make studies more accessible for patients living great distances from traditional academic study centers and patients with other life circumstances that make frequent clinic visits challenging.
One aspect of study design to consider when building better research experiences for patients is a genuinely patient-centered eCOA (electronic clinical outcome assessment) program. Here are some tips for ensuring that your eCOA is built with the needs of patients in mind and able to deliver the kind of engagement necessary for successful trials.
Tip 1: Get the Endpoints Right
It is easy to get in the habit of selecting study endpoints in a vacuum, considering what to measure from strictly a scientific view to gain regulatory approval of the endpoint strategy. This is important, but there may be other insightful endpoints that are of great relevance to patients. For example, blood pressure changes, ECGs (electrocardiogram), blood oxygen, and others are vital. However, the patient may place a higher value on the ability to sleep through the night, the ability to walk without pain, or have the energy to leave the house, making it important to include different types of measures. Selecting these kinds of quality-of-life endpoints helps to make patients feel like they are part of the team and that their study team cares about their quality of life. They also provide additional insights into drug impact that can be hugely beneficial both during regulatory review and post-approval marketing. Working with a team of clinical research experts early on in your study design can help ensure that the study captures all meaningful endpoints.
Tip 2: Listen to Your Patients
To focus on the core concerns of patients, we need to listen to them first. Patient listening is the new normal in clinical research. For example, through our Listening Platform, THREAD helps study leaders collect comprehensive insights from patients by recording and analyzing their voice data. This data is mined for quantitative and qualitative information. The technology helps us go beyond the patients’ answers to questions and measure how they respond, e.g., their tone of voice, tremors in speech, and more. This level of patient listening informs study design and the creation of patient-facing materials, such as clinical outcome assessments (COA).
Tip 3: Make It Easier to Engage
We are all now used to managing our lives with the help of technology. The phones in our pockets help us to plan meals, know when to pick up our kids, and when our electric bills are due. As we’ve all experienced, we are much more likely to use a smartphone app if it is easy to pick and use immediately. At the same time, some of us know what it is like to have older parents who prefer using a computer or avoid any technology newer than a landline telephone. It is no different when developing a patient-centered eCOA strategy. If we have done our homework in terms of patient listening, we should have a better idea of how our target patient populations want to handle their assessments. Do they want to make clinical visits and fill out paper assessments? Do they want to quickly be able to tap a few buttons on their phone while watching TV at home? It is essential to tailor the COA strategy to the users.
For this reason, THREAD’s platform allows for an omnichannel approach that allows participants and/or caregivers to submit eCOAs through a web browser or via an application on their own devices or provisioned devices. This means that patients can engage with eCOAs the way they want, and by making it easier for them to engage, we can help keep them active and involved in the study.
A modern eCOA strategy can have a significant impact on patient engagement. A three-point strategy that helps to define and deliver eCOA solutions with patient needs in mindsets study leaders up for success. At the end of the day, patients want to be included as part of the research team. If we can listen to them, include study measures that matter to them, and take the steps to make participation simpler, we can show patients how important they are to research while collecting better data.
For more information, visit THREADResearch.com