Technology today has given patients unparalleled access to information and influence over their health care. As a result, many clinical trial sponsors now recognize the importance of taking a “patient centric” approach to clinical trials. That means designing a treatment, clinical trial, or other health solution centered around the patient, and includes getting feedback from patients, caregivers, families, and advocacy groups every step of the way.
In other words, it means treating patients as informed stakeholders whose participation is key to a successful trial and product following marketing authorization. Engaging patients and truly bringing them into the product journey has the power to transform the future of research and medicine. Read on to understand what patients expect from clinical trials today, and how to engage them throughout the product journey.
Understanding the Digital Patient Journey
Compared to patients even a decade or two ago, patients today have easy access to a wealth of health care-related information. This includes information about disease states, locations of clinical trials, drug mechanism of action, results of similar clinical trials, and more. Today’s better-informed patients are now empowered to create a health care journey that’s personalized to them, and expect clinical trials to meet them on their own terms—which means expecting a more comfortable and engaging trial experience, as well as outcomes that are meaningful to them.
How Sponsors can Make Drug Development Patient-Centric
In July 2014, the Food and Drug Administration (FDA) released guidelines on building effective Informed Consent Forms (ICFs), which should always be used as a reference point. In concert with those guidelines, there are multiple evidence-based ways for sponsors to create a clinical trial process that revolves around the patient.
Actively solicit patient input in ICFs
In addition to using clear, concise, and simple language, having your ICF reviewed by a typical patient may help bring to light potential areas for confusion. Clarifying these sections can potentially lead to greater engagement with a larger patient population, as well as increased retention throughout the trial, as patients who better understand what’s required of them are less likely to drop out later.
Utilize protocol design that considers the patient’s needs
Before creating the study protocols, gain a full understanding of the real-world demands and limitations placed on your patient population. Including patient-friendly protocols, and ensuring the study staff are attuned to patient needs, can go a long way to promoting a better retention rate.
Create trial endpoints that are meaningful to the patient
If patients understand the endpoints being studied and these are meaningful to how they both feel and function they are more likely to be engaged throughout the length of the study. And if participants are engaged, the chances they will continue on the study throughout the duration of the trial are much higher.
Include Patient Reported Outcomes in labeling claims
Patient Reported Outcomes, or PROs, are based on a report that comes directly from the patient about the status of their health condition, without interpretation from a clinician or anyone else. These include symptoms or other concepts that are not observable and known only to the patient (for example, pain severity or headache intensity). Empowering patients with an opportunity to directly impact labeling claims is an exceptional opportunity to keep patients engaged and interested in the trial process.
Make use of Digital Health Technologies to reduce patient burden
Lowering patient burden throughout a clinical trial can go a long way to boosting retention. By utilizing digital tools such as TeleVisit, and allowing for a hybrid clinical trial experience, it’s possible to provide a more convenient, flexible, less burdensome trial experience for patients and their caregivers.
Actively engage patient advocacy groups
Patient advocacy groups, such as Patients Rising, can play a critical role in educating, advocating for, and supporting both patients and caregivers. When properly engaged, patient advocacy groups can align patients and healthcare providers with shared goals to advance treatments, and provide valuable feedback to help shape trial design and conduct.
Utilize patient registries
Patient registries, such as Patients Like Me, allow patients to connect with a community of patients with the same condition. This provides an important outlet for patients to contribute feedback to treatment development, while giving researchers an opportunity to compare the effectiveness of different treatments, evaluate different approaches to a procedure, and monitor the safety of a treatment.
Medable is at the forefront of developing cutting-edge, patient-centric digital health solutions which drive downstream trial efficiencies and reduce the traditional bottlenecks common to clinical development.
We have also developed an industry-first training program designed to empower pharmaceutical industry with the knowledge to design, build, deploy and support decentralized and hybrid trials. In addition, we bring the patient voice directly to you through our Patient Caregiver Network.