Tips to achieve patient centricity in trial design
Volunteers play a vital role in clinical trials; nevertheless, the participant experience is often suboptimal. In an interview with Newsweek, Paul Wicks, former VP of Innovation at PatientsLikeMe once remarked, “Sometimes, it’s almost as bad as dealing with Comcast or the worst airline.” When patients are faced with overwhelming paperwork, inconvenient appointment times, and tedious symptom recording, enrolling in a clinical trial can feel more like an extra burden than a potential breakthrough.
The negative experience affects both patients and sponsors. The prolonged enrollment of patients increases the cost of conducting research. Fortunately, prioritizing patient-centric trial design can enhance the patient experience and contribute to the success of studies. Sponsors can guarantee that the potential treatments being tested align with patient needs, the measured endpoints are meaningful, and the testing methods are acceptable. But what does this prioritization entail? We’ve pulled together a few tips to help R&D teams ensure patient centricity in trial design.
How to design patient-centric clinical trials
Work with patient advocacy organizations. Patient advocacy organizations are a fantastic resource for trial design guidance due to their deep connection with patient communities. Oftentimes, patient advocacy groups can help sponsors consider the structure of their trial, the inclusion and exclusion criteria, and the real-world impact that participating will have on patients. These groups are often happy to weigh in on both the purpose and the logistics of the trial — and may even be able to connect you with patients to interview as well. Working with a recruitment company that has relationships with these types of organizations can help facilitate these conversations and serve as an important resource throughout the process.
Connect with patient influencers. Many patients are members of grassroots online communities and are often open to share their experiences and weigh in on study design. Social listening, searching relevant disease hashtags, and following along on Twitter threads can identify the most active and influential groups to connect with for opinions straight from patients.
Try a live protocol simulation. A live protocol simulation is when sponsors invite patients for a dry run of the trial appointments, and they are an excellent way to determine if the trial protocol is applicable in the real world. In one example, AstraZeneca hosted a lupus clinical trial simulation to measure how patients felt about the way they were planning to run their trial and received many recommendations for how to improve the experience.
Use real-world data. Access to patient data from previous trials or trial searches can serve as a valuable resource to determine what experiences have been in the past. Searching through this data for contributing factors such as strict eligibility criteria, inefficient targeting, or difficult site processes can help sponsors determine what elements of the new trial design can be adjusted to ensure patient centricity.
If you need assistance with designing or recruiting for a clinical trial, Antidote is here to help. With real-world data, relationships with patient advocacy groups, and full-service recruitment options, we are happy to help — learn more by getting in touch today.