Rethinking Clinical Operating Models: Moving from Ideas to Actions

When asked to the audience, “Do we need to rethink clinical operating models?” most of the audience responded with a resounding, “yes.” In the spirit of leaving legacy behind and ensuring patients and sites have the support and infrastructure needed to be successful, a group of expert panelists gathered to discuss Rethinking Clinical Operating Models: Moving from Ideas to Actions – a panel examining what should be kept, reinvented, or cut.  

A lively discussion followed. 

Leading the talk was Sheila Gwizdak, VP, Strategic Consulting Solutions at Halloran, and featuring the following panelists: 

• Michael Goedde, President, BioForum 

• Suzanne Vyvoda, Founder & CEO, Concordia BioStrategies 

• Adrine Kung, SVP, Head of Strategy & Planning, TORL BioTherapeutics  

Whether you attended CORE or not, most people agree; clinical trials are expensive and take years to progress. With such high stakes in play and the prevalence of so many processes that are wildly inefficient, as an industry, we are overdue on restructuring how the right players are involved to enable a successful trial. 

Sustain These Practices 

Many processes, assumed necessary, simply do not propel development forward. While there are some things that you just can’t get around, like regulations, a panelist noted, even with regulations from health authorities, sometimes a no is a conditional yes. But this requires a deep understanding of those conditions and requirements to meet before being able to maneuver around or through them to push innovation forward. 

In summary, here are the panelists’ responses on what to keep: 

• Remember to stay patient centric, continue to customize trials and adopt creative approaches, and work to reframe the narrative that patient-centricity is at odds with ROI or is mutually exclusive.  

• Keep pushing innovation forward and looking for new discoveries. 

• Maintain a mindset of adaptability and resilience, especially during times of uncertainty and change, holding fruitful discussions to do things differently. 

• Collaborate with global regulators – offer feedback on guidances and find ways to influence guidelines to benefit the research and development community, at large. 

Practices to Adapt 

Panelists were encouraged to share bold, provocative ideas, offering suggestions that may just land within some of the attendees’ organizations – a backbone of the event. 

Building off earlier discussions from the day, especially the topic on Real-World Perspectives on Patient Recruitment and Engagement, suggestions included: 

• Get rid of 100% Source Data Verification (SDV), supported by observations that there is no quality improvement doing 100% SDV and no guideline to support otherwise (proved to be a controversial suggestion!) 

• Cut out biometrics in broader input into clinical protocol development designs, focusing more on the data and patient perspective in protocol design.  

• Reframe the question, “How quickly can you (the Clinical Research Organization (CRO)) build your Electronic Data Capture (EDC) database?” and more towards “How can you ensure the data will be ready for submission? What is the best way to collect data? How can you provide input from a biometrics perspective?” as that will better move the needle. 

• Encourage your team (or leadership) to move beyond treating a protocol like a scientific document, but rather, an operational document that is going to guide the entire conduct of the trial. For that to be operational, key functions must provide input from the onset. 

• Over structuring and over siloing activities, often a result of the mindset of “should be” instead of “fit-for-purpose” within a given organization, challenging assumptions of structure to ensure a trial is truly operationalizable.  

• Disparate trackers and move more towards efficient tools to provide a single source of data truth. 

• Reframe the narrative around CROs, remembering they are a partner with lots of exposure to many sponsors, technologies, studies, and processes compared to what may be observed at any given sponsor organization. 

As a community, improvement happens when repeating mistakes isn’t made, and we collectively improve. A big statement. Yet, possible in little steps. Taking these considerations to heart, the question was posed, “how do we educate the community in a way that we advance together?” 

Reinvent and Innovate 

• Develop shared knowledge across industry, including best practices across processes, including protocol-specific findings found during audits, for industry-wide visibility and consistency.  

• Involve strategic thinkers across all key functions of running a clinical trial from the onset to ensure less firefighting is done on the back end, reducing the risk of trial failure. 

• Clearly identify what success and failure look like upfront along with supporting criteria to inform decisions as to whether to pivot or sunset, when needed. 

The panel discussion led to an interactive workshop, Trial Redesign Challenge: Turning Ideas into Blueprints, offering an opportunity for attendees to build off the feedback shared during the panel, meeting in five small groups around the following topics: 

• Trial design and protocol innovation 

• Site and patient engagement 

• Data and digital enablement 

• Quality and risk-based oversight 

• Clinical supply and business continuity 

Representatives from each group shared their ideas to revamp each of these five topics, including what to keep, cut, and reinvent, enabling the panel to judge the ideas along a bold meter – truly, the spirit of CORE – rethinking, pushing boundaries, and sharing knowledge that is implementable. 

Looking to enhance your clinical operating model? Halloran can help. Continue the conversation with us today.