By Allison Proffitt 

November 19, 2024 | Pharma leaders took on clinical trial quality in a panel discussion at the SCOPE Europe conference last month in Barcelona. While technologies change, the conversation underscored a central truth: the push for quality in clinical research remains as vital, yet as challenging, as ever. 

The session, led by Patricia Leuchten of Diligent Pharma, traced the arc of quality practices in the pharmaceutical industry over the last two decades. Leuchten was joined by Colleen Glessner, executive vice president of Quality, Ethics and Compliance at Emergent Biosolutions and Kristine Koontz, VP Global Clinical Operations at Daiichi Sankyo. Drawing on her experiences across companies such as Pfizer and Alexion Pharmaceuticals, Glessner defined “quality” in clinical trials as the absence of errors that matter to decision-making. “We’re not doing it for the sake of quality; we’re doing it to make the right decisions about our products for our patients,” she said. Quality and efficiency go hand-in-hand, Glessner continued. “Better, smarter, faster should drive better quality if you get it right.”  

She noted that while quality standards like patient safety, data integrity, regulatory compliance, and product quality have always been the tenets of clinical trial quality, the methods for maintaining these standards have grown more complex. 

The focus has shifted, Glessner said, from just “checking things” through audits and inspections to emphasizing preventative measures. She recalled her time at Pfizer when ensuring quality meant metrics and key performance indicators.  

“I was so proud at the time, and I’m so embarrassed now! We had over 200 measures for clinical trial quality. Who can actually measure quality with 200 measures?” she said. “I’m proud to say the industry is finally getting very smart and going upstream, going to the prevention of errors.”  

Transition to a Risk-Based, Proactive Approach 

Kristi Koontz, a leader in clinical quality at Daiichi Sankyo, echoed Glessner’s insights, describing her own shift from big European pharma companies with traditional, well-defined quality assurance processes—AstraZeneca and GSK—to her current role in a medium-sized organization where she has been building a Clinical Quality Assurance (CQA)-like team from the ground up. Koontz pointed out that her journey with quality has evolved “from reactionary to proactive,” due largely to the organizations she was in and the flexibility and resources available at larger pharmaceutical companies compared to smaller organizations. 

With the advent of risk-based monitoring and data-driven approaches, both Glessner and Koontz emphasized that companies are increasingly adopting quality-by-design practices. These approaches, grounded in risk assessment at the earliest stages of clinical trial design, prioritize embedding quality directly into protocols rather than relying solely on retrospective checks. According to Glessner, such forward-looking methods can prevent errors, reducing the need for time-consuming audits later in the process. 

Industry Faces Barriers to Implementing Quality-Driven Change 

Despite the progress, the panelists noted a range of challenges. “Prevention is really a difficult cultural mindset to get, and it’s difficult to ensure that the financial investment is made,” Glessner observed, adding that while companies may understand the benefits of proactive quality management, the costs of implementation remain high. Koontz agreed, suggesting that an industry-wide shift toward risk-based quality approaches is still in its infancy. She explained that even organizations with well-established quality infrastructures can struggle to unify all parts of their operation, resulting in silos that make it difficult to implement consistent standards across departments. 

Both panelists emphasized the importance of senior leadership in championing quality initiatives. Koontz suggested that frequent leadership turnover in the industry can create further roadblocks, as new leaders often need time to adjust to the culture and processes of their organization. “It takes a leader a while to get into an organization, to find a level of stability, to understand the culture, and then create a sense of credibility that you can then influence senior leaders to get the resources,” she said. 

The Growing Role of Data in Quality Assurance 

As the panel discussion turned to the issue of data management, Koontz pointed out the impact of the industry’s digital transformation, which has brought vast amounts of data to clinical trials. With the rise of wearable devices and other data-generating technologies, companies now face both the opportunity to enhance quality and the challenge of managing unprecedented quantities of information. Koontz shared how she’s using data to back her requests for resources and support, particularly when it comes to securing vendors to help streamline quality management across clinical operations. 

The more data I have, Koontz said, “helps me negotiate a conversation with senior leadership to secure resources.” By presenting measurable results, she’s able to underscore the value of data in quality discussions and build stronger cases for necessary infrastructure. 

The Path Forward: Balancing Quality and Speed in Clinical Trials 

The panelists reflected on how to achieve the balance of moving clinical trials forward at the required pace while maintaining rigorous quality standards. Glessner underscored the need for a system that goes beyond technology—one that brings together the right vendors, expertise, and resources to ensure quality becomes an integral part of clinical trials. 

While they expressed optimism that the industry would continue evolving toward a culture of quality-by-design, they also acknowledged the difficulties of widespread adoption, especially for companies with limited resources.  

The panel concluded with a call to action for those in leadership to foster environments where quality is embedded across every stage of development, creating trials that are both efficient and reliable. As data and technology continue to reshape the industry, the importance of quality as a proactive, design-focused element remains a critical focus for the future of clinical trials. 

Clinical research is really a privilege. “It costs a lot of money to do a clinical trial,” Glessner said, “Dedicating resources to it doesn’t mean assigning a person; it means assuring there’s a person who is equipped to execute and you have the infrastructure for them to be heard.”