Maggie Adamski 

Closing the loop in understanding the benefit of patient centric clinical trial design—perspective from a patient insights team

As a team dedicated to conducting insights research, we have observed first-hand the value of engaging with patients, family, caregivers, advocates and Heath Care Professionals to inform protocol design, study optimization as well as patient recruitment and retention strategies. We have received positive feedback from our interview participants as to how appreciative they are that pharma is endeavouring to ask their opinions. We have seen study teams apply our actionable insights to critical areas such as adding a treatment arm, determining their data collection methods, modifying their recruitment messaging, enhancing retention logistics and even changing endpoints to name a few. If for nothing else, sponsors are checking off their list that they are following FDA guidance while building partnerships with patient groups.

However, after all this positivity, in this data-driven industry of tight timelines and limited study funds, during the bidding process, applying insights is still a “nice to have” and the decision to include as part of a study comes down to knowing if it is worth the money—what is the ROI? Study teams tell us that they know all about this patient and have done similar studies so what would they gain from the investing budget in patient insights?

From our experience, having conversations with as few as three or four patients is impactful and should be as routine as conducting feasibility. Each study is actually as unique as the patients who participate in it so it is worth getting that perspective.

Identifying what actionable insights have been initially applied has been fairly easy to learn and report on, however, when asked for hard data on the impact of these changes, this is where we run into challenges. Unless it is a pilot, it is not clear that anyone is tasked with tracking and obtaining ROI at the end of the treatment period to understand if the insights applied made a difference, especially if the study was successful in achieving its goals. Did the messaging make a difference in recruitment? Was there a reduction in the number of amendments from the additional treatment arm? Did the data collection methodology improve data quality? While we know collecting insights from patients and their circle of care allows sponsors to say they have created a “patient–centric” trial, are these changes having significant impact and what are sponsors doing to actively measure this impact beyond “checking off the box?” 

This does not have to be difficult and highly scientific to operationalize a process and make this the standard in study planning and conduct. Here are a few practical suggestions:

Think of your typical study planning and start up activities. Similar to designing and distributing a site feasibility questionnaire and tracking responses against performance, create one for patients and caregivers. Remove your clinical hat about what you think you already know about this patient and approach this with an open mind. If you were sitting across the table from a patient, what would you want to know and test specific to this study? Is it related to protocol design, messaging that would resonate, recruitment sources, PRO preferences, visit schedule and visit type? Apply this information to your participant discussion guides and surveys to personalize the questions and uncover this information. 

Document insightsthat are collected from the interviews/surveys

. What suggestions were actually applied to the study—adding home health visits, creating a patient video, adding a treatment arm, using a specific data collection device?

Track the impact of applied insights against KPIs. 

By modifying what you originally asked of the pre-study participants, and conduct brief interviews or surveys of actual study patients, site staff and even study team members responsible for tracking study performance (e.g., project managers, site liaisons, enrolment specialists). Establish specific time points in your study timeline such as rolling interviews mid and end of study treatment and add as a topic in your weekly meetings or reports. Use this data to determine if they met the KPIs. Did the actionable insight contribute to meeting enrolment goals? Did they improve adherence? Did they reduce anticipated amendments? Did they make the patient more comfortable?

. Whether it be your designated insights specialist or a study manager to ensure no step is missed during the study.

While this may seem at first glance to be a lot of extra work, consider that this does not require a large number of participants. Once you start to see the outcome and continue to apply to future studies, ultimately a “patient-centric” study will be more than just the latest buzzword but part of the DNA of successful study conduct. 

is the Global Patient Insights Director, Patient Recruitment Solutions, for ICONplc

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Practical suggestions for identifying what actionable insights have been impactful on clinical studies. 

Maggie Adamski

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How to Measure Your Patient-Centric Impact