Editor's Note: This article is part ofthe 2023 Red Jacket Awardspecial report.

In April 2002, Time magazine published an issue witha now-famous cover: a disgruntled patient in a hospital gown sat in an animal cage. The headline read: "How Medical Experiments Are Turning Millions of Us Into... Human Guinea Pigs."

Ken Getz, then a professor and executive director at Tufts University School of Medicine'sTufts Center for Drug Development Researchrecalled wondering if anyone in the industry would step forward to defend the importance of clinical research. But he was also thinking about the situation of the "guinea pig" on the cover.

"What struck me most was that no one came forward to defend the woman in the cage—the image of the research volunteer," Getz said. He believed the depiction was almost an "insulting" disregard for the contributions of clinical trial volunteers.

"At that moment, I thought we needed a more systematic and effective way to educate the public and patient communities about the valuable role of participating in clinical trials," he said.

The following year, Getz founded theCenter for Information and Study on Clinical Research Participation (CISCRP). The organization is dedicated to educating patients and their families about clinical research and the role of participants, and it conducts direct community outreach. Additionally, CISCRP offers a free clinical trial search tool to help patients connect with trial programs. CISCRP also collaborates with the industry to provide plain-language communication services, research services, and content licensing.

Getz has been named to the PharmaVoice 100 list multiple times and is now a Red Jacket Award winner. He has decades of research experience and expertise in drug development and clinical trial management, and he was an advocate for the concept of patient engagement long before it became a recognized term.

"Many organizations we approached looked at us with confusion, thinking 'Why do we need this?' About 15 years ago, the patient engagement movement really took off, and we happened to be in the right place at the right time," he said. "Now, the number of organizations seeking CISCRP's support and assistance has noticeably increased."

Twenty years later, Getz has become a recognized leader in the clinical research field, with influence extending beyond the patient perspective. In his current role, he and his team work to optimize the drug development process.

"For me, this is the ideal workplace," he said. "It's an academic group with nearly 50 years of history, focused on conducting rigorous empirical research, gathering solid evidence, and educating the drug development community on how to optimize its performance, efficiency, quality, and economic benefits."

"There is growing recognition of the need to balance excellent science with excellent execution."

— Ken Getz, Professor and Executive Director, Tufts Center for Drug Development Research

The center shares its research findings with major regulatory agencies, government policymakers, foundations, industry associations, and industry participants, covering topics such as protocol design, patient recruitment and retention, drug development costs, and clinical trial success and failure rates.

"I hope our research provides valuable reference for pharmaceutical, biotech, CROs, and other organizations serving the clinical research industry," he said.

PharmaVoice spoke with Getz about his work, the clinical research trends he is following, and opportunities for continuous improvement.

This interview has been edited for length and style.

PharmaVoice: Can you talk about trends in clinical trial design and how these have changed over the years?

Ken Getz:There is growing recognition that balancing excellent science with excellent execution is crucial. Years ago when I first entered the field, the industry focused only on the science itself, spending heavily on operational support without recognizing the high costs and inefficiencies. I believe the industry continues to innovate, striving to find a balance between careful planning and operational activities, which are now better managed and supported by numerous new technologies such as electronic data capture.

Although we have made many improvements, we have also identified more room to enhance efficiency and effectiveness. Part of the reason is the increasing complexity of the work we do. The pace of this complexity change has exceeded our ability to adjust our scientific and operational approaches to improve performance, speed, recruitment, and retention. Due to the highly customized and fragmented nature of current research, these goals remain difficult to achieve.

What other areas in clinical research need improvement? How do you think they should be addressed?

Almost every aspect of clinical research presents significant opportunities for improvement and efficiency gains. The two most critical drivers of current operational conditions are the degree of customization in clinical trials. This is directly reflected in protocol design: the patient populations we target are increasingly narrowly defined; the research questions are extremely complex; the volume of data collected is unprecedented; and we have introduced more intermediaries to support protocol execution, including contract research organizations, trial sites distributed across many countries, and now technology vendors offering virtual and remote solutions. Therefore, the challenge at every step is: how to optimize performance and quality in such a highly customized and fragmented operational environment. Currently, every trial is unique, and given this level of customization, it is difficult to systematically apply standardized methods.

What current changes are you excited about?

What excites me is the opportunity to update the research we have conducted in the past, and also the emergence of new areas supporting clinical research. When direct-to-consumer providers entered this field, I was very excited. When retail pharmacies announced their intention to support clinical research activities, I was also excited. It is a constantly changing, dynamic environment.

I am also encouraged by the growing interest of regulatory agencies—especially the U.S. Food and Drug Administration (FDA)—in becoming a more proactive and inclusive partner in supporting drug development.

Of course, I am passionate about advancing patients and communities as partners in the research process. The entire diversity, equity, and inclusion movement is very exciting for me and my team; it is an important area that has been neglected for too long, and we need to support it with more effective methods on an ongoing basis.

View our full2023 PharmaVoice 100 winnerslist.