Having worked for more than two decades as a research scientist before moving into clinical trials management, Tet-Kin Yeo brings an understanding of the full spectrum of clinical research to the classes she teaches for the Clinical Trials and Regulatory Management certificate. More than just the rules and regulations, she is able to give students important insight into the variety of ways the administrative side of clinical research can step in and assist scientists in streamlining the clinical trial process.
“I love teaching and interacting with students,” she says. “I’m especially interested to share with them my experience and knowledge about the clinical trial process while also giving them the unique perspective as an investigator I gained during my career doing research in basic science.”
After completing her PhD in cell biology, Yeo began a career working on preclinical and clinical research projects that took her from Harvard’s Beth Israel Hospital to Tufts, Dartmouth, and Northwestern before arriving at the University of Chicago in 2013. Having done work on wound healing, cancer and kidney diseases, as well as research into mitochondrial genetics, Yeo’s initial exposure to the administrative side of research took place while working on a series of projects that put her in contact with the Institutional Review Board (IRB), the body responsible for the welfare of patients in clinical trials.
“That’s what first alerted me to my possible interest in regulatory management,” she says. “During my three years at Northwestern, I learned more about the administrative side to clinical research and decided to enroll in a certificate program on clinical trials similar to the one offered through the Professional Development Certificates (PDC) program. It allowed me to ground my knowledge of the clinical trial process and the regulatory compliance practices that go along with it. The question from there became how I would progress from the basic and translational science research I’d been doing to the clinical trials and regulatory side.”
To accomplish that, Yeo volunteered as a project coordinator, became an IRB member, and networked all she could. In the end, her hard work paid off and she landed a position working as a clinical research project manager at UChicago. Two-and-a-half years later she was promoted to associate director of investigator services.
“My unique background has allowed me to support investigators across the entire life of the trial, particularly in the beginning when trial initiation involves FDA and other regulatory bodies’ involvement,” she says. “Knowing firsthand the sorts of pressures clinical researchers face and the increasing complexity of federal and local regulatory requirements, I’ve been able to facilitate their clinical trial research by thoroughly understanding the areas around compliance.”
“Having a firm grasp of these practices and how they fit in and support the different stages of a clinical trial is integral to the trial’s success, so working in regulatory compliance comes with a lot of responsibility as well as the potential for significant personal fulfillment.”
In the first class she developed and taught in the certificate, Introduction to Clinical Research: Protocol Development, students will learn the requirements for a successful clinical trial from concept to closeout while gaining foundational knowledge in protocol development with the participant’s safety and regulatory compliance in mind. Along the way, they will have the opportunity to discuss the full range of issues that arise during protocol development, everything from testing study feasibility to ethical questions dealing with population and procedures, as well as issues surrounding site resources and facilities.
“The course is designed for those interested in starting a career in clinical research, as well as those looking to understand more about protocols,” she says. “Either way, gaining insight into the core aspects to successful protocol development is essential to understanding not only the complexities of clinical research but also the rewards stemming from exercising diligence in developing a well-planned protocol.”
In her second class, Good Clinical Practices, which she will begin teaching this July, Yeo provides an introduction to the best practices underlying clinical research according to FDA regulations and the International Conference on Harmonization (ICH) guidelines. Developed after a series of calamitous clinical trials more than 60 years ago, the regulations and guidelines known as good clinical practice (GCP) have evolved into the code of practice everyone working in clinical research now works with.
“As we cover GCP, we’ll go over the regulations established by state, federal, and international regulatory bodies, as well as the roles and responsibilities of investigators, sponsors, monitors, and auditors,” she says. “Having a firm grasp of these practices and how they fit in and support the different stages of a clinical trial is integral to the trial’s success, so working in regulatory compliance comes with a lot of responsibility as well as the potential for significant personal fulfillment.”