Bayer taps Clariness to build patient insights into clinical trial review process
Under its new approach to study review, Bayer is trying to combine insights from different stakeholders to design more patient-centric studies that have improved enrollment and retention. Fenja Kruse, team lead patient insights at Clariness, explained how her team will support Bayer’s approach using patient insights.
“Pre-trial insights can provide more accurate views of eligible patient populations, discover the right sites, and pre-empt participation barriers, and even potential treatment design flaws that come with high costs,” said Kruse. “Post-trial insights can provide us with more accurate estimates for future trial participation, help sites and sponsors remove unnecessary bureaucratic hurdles, and more importantly improve the patient’s enrollment and study journey.”
Clariness starts by working with the sponsor to define the objectives and build a picture of the aspects of the trial that will be affected by the patient insights. That done, the company gathers the patient insights by running surveys, conducting interviews, and using social listening tools.
“Once we launch our surveys, we get thousands of responses from international patients within days, which we then analyze, feedback to the sponsor and typically, we would then pull out key responders with whom we host patient interviews with, or build further surveys to dive deeper into the responses and trends which would impact the objectives of the research most,” said Kruse.
Kruse divides what Clariness typically learns from pre-trial patient insights into four categories: patient characteristics, lived experiences of patients, the patient population’s medical knowledge, and practicalities of participation. Across those areas, the company sheds light on which demographic is most willing to participate in a trial, how many patients can access sites, and the most impactful symptoms.
Once a clinical trial is underway, Clariness gathers patient exit experiences and feedback. The surveys collect the views of people who leave and complete clinical trials to validate the pre-trial assumptions, and assess the on- and off-site experiences of patients.
Kruse sees the patient experience side of the process as the most important, explaining that it can reveal off-site learning such as how easy it was to reach the study center and on-site learnings such as whether staff were respectful and empathetic.
