Improving Care through Investigator-Initiated Trials

As an oncologist at The University of Kansas Cancer Center, I am in the clinic every day treating individuals with cancer. It is challenging, rewarding work. I am also a scientist.

Physician-scientists like me are dedicated to both patient care and research discovery. This combination of skills is frequently found at academic medical institutions and National Cancer Institute (NCI)-designated centers such as the KU Cancer Center. Here, Investigator-Initiated Trials (IITs) provide a great opportunity to receive cutting-edge therapies that are not available at other facilities in the area.

What Are Investigator-Initiated Trials?

By providing direct patient care, I am familiar with real-world patient outcomes of standard treatment strategies, as well as the biology of the disease and treatment landscape, providing an understanding of unmet needs in managing cancer.

As a physician-scientist, I can design and initiate my own clinical trials. Most clinical trials are conducted by the pharmaceutical industry, but IITs allow specialists to take clinical observations and try to improve or develop new therapeutic approaches. For example, I am leading an ongoing IIT that evaluates a novel targeted therapy, called PARP inhibitor, to treat pancreatic cancers containing DNA repair defects. The current standard of care for pancreatic cancer is “one-size-fits-all.” In other cancers, some treatments are tailored based on specific genetic or molecular features. This motivated me to launch the first clinical trial targeting both major and minor DNA repair defects in pancreatic cancer.

Another advantage of IITs over industry-sponsored trials is the doctor’s ability to tailor the clinical trial rationale, objectives and treatment algorithms.

IITs tend to address more meaningful clinical questions. If IIT outcomes are promising, it potentially paves the way for large, randomized trials that could actually change the way we treat patients. Also, additional related studies can be built into IITs that may help us better understand the interaction between cancer, therapies, genes, environments and lifestyles, which is very useful for designing future clinical trials.

JCERT’s Role in IITs

IITs require a complex support system, including quality control and quality assurance oversight, and the KU Clinical Research Center – funded in part by the Johnson County Education Research Triangle (JCERT) – provides the ideal infrastructure to develop clinical trials. A steering committee consisting of clinical trial leaders, scientists, pharmacologists, biostatisticians, regulatory and budget analysts provides valuable input into the design and logistics right from the trials’ initial stage. We also have an in-house molecular oncology lab to study patients’ tumor cells and personalize their care. The recent NIH award to establish the Kansas Institute for Precision Medicine will further augment IIT efforts.

As an academician, I truly feel conducting IITs is one way I contribute to move the scientific field forward and also impact patient care at an individual level.

There is always room for improvement in patient outcomes, and my personal goal – and the goal of the KU Cancer Center – is to have a clinical trial option for every patient, at every stage of cancer and at every line of treatment.