By Deborah Borfitz 

March 15, 2021 | The need to listen to the voice of patients at the right time, in the right context, and in their own language was a dominant theme of a live panel session at the recent Summit for Clinical Ops Executives (SCOPE) where views were shared on integrating patient insights into clinical trial design. Patients need to be engaged throughout the life of a clinical study starting from when the protocol is being conceptualized, says moderator Michelle Shogren, senior director of innovation in pharma R&D clinical operations at Bayer HealthCare. 

Despite an abundance of technology tools to aid in protocol development and trial awareness, and gather patient insights, clinical operations teams still work in silos, says Evi Cohen, vice president of global life sciences and healthcare at Appian. While technology alone is insufficient, accelerating decision-making at scale requires a platform to “connect the way people do work.” 

Pfizer utilizes a protocol optimization workbench and an array of tools and tactics, including feedback from patients and investigators, to improve the feasibility of its study protocols, says Oriol Serra Ortiz, the company’s global head of site intelligence & site selection. The inputs include real-world evidence from sites as well as census, claims, and electronic health records data. Currently under development is a project that will “find patients to find sites.”  

Protocol simulations and patient insights are used by Pfizer to identify aspects of studies that are “problematic” for participants, adds Melanie Goodwin, Pfizer’s global director of patient recruitment programs in clinical development & operations. The feedback of patients and site staff are funneled back to study-building teams.  

Efforts to get out of pilot mode on projects amplifying the patient voice include Bayer’s “holistic approach” that includes exit interviews with trial participants, says Daniela Franschman, global head of patient recruitment & retention. The company is formalizing its patient engagement intentions with the development of patient portals to capture trial journeys more regularly and continuously improve on the experience.  

“The journey starts with insights up front,” says Kafayat Babajide, associate director of patient portals with Janssen Research & Development. Janssen conducts surveys with potential interested patients and will also be developing a patient portal to get “real-time feedback” to deliver on its engagement and transparency goals.  

Capturing patient insights without further burdening them with questionnaires is the aspiration of Allam Fakhoury, PharmD, head of portfolio design and execution at AbbVie. He is keen on automating the extraction of information in electronic health records in a blinded fashion and notes the company will also be conducting an observational trial in a phase 1 unit. 

When thinking about integrating insights into trial design, Babajide recommends using a “consult-consider-confirm” approach to keep the focus on what is urgent and feasible.  

A good starting point would be the patient-reported outcomes questionnaire, which represents the single most burdensome assessment on the schedule—higher even than a bone marrow aspiration among patients with cancer, says Fakhoury. A single survey may take four hours for some patients to complete.   

Cohen’s advice is to remove mundane tasks through automation. He favors the Lean Startup concept of the build-test-learn feedback loop.  

Franschman’s call to action was to “look for opportunities to leverage the patient voice and utilize available resources.” TransCelerate, she notes, has a library of questions that can be used in developing patient engagement activities.  

The only way to speed enrollment is to incorporate patient insights “from beginning to end,” says Goodwin. What makes sense for one organization may not for another.  

Pharma needs to shift from having transactional relationships with patients to building partnerships, adds Ortiz. “How best can we meet study goals together?”  

In response to an attendee’s question about the use of artificial intelligence (AI) to engage patients on social media platforms like Facebook, Instagram and Twitter, Cohen advises proceeding with caution. Using AI to guide decision-making could drive outcomes not expected.  

Shogren fields the final question about creating meaningful relationships with patients across markets and geographies. Bayer’s approach is to create patient personas. Understanding cultural differences requires insights from patients on a global scale, she says.