The Importance of Clinical Trials

By Tara Lin, MD, Medical Director, KU Cancer Center Clinical Trial’s Office

Survival rates for all cancers combined have improved over the last four decades. According to an American Cancer Society 2016 report, the cancer death rate fell 23 percent from 1991 to 2012, translating to more than 1.7 million lives saved during this period.

If you ask any clinician or researcher why cancer death rates have dropped so dramatically over the last several decades, you’ll likely hear the same answer from everyone: most of those lives were saved due to advances in cancer treatment.

As both a clinician and a researcher, I agree. But my appreciation of those advances goes deeper than that. Those groundbreaking therapies – which have saved millions of lives – are available to us because thousands of patients chose to participate in a clinical trial.

What is a Clinical Trial?

Before a new therapy becomes FDA-approved and available to the broader population, it must undergo rigorous testing to demonstrate it is safe and effective. No matter how promising a treatment looks in the laboratory, it cannot be approved until it has been tested on actual patients in the clinic. Clinical trials are the research mechanism by which new, cutting-edge, less-toxic drugs and treatments are given to patients to determine their safety and effectiveness.

Case in point – earlier this year, findings from a National Cancer Institute-funded clinical trial made national headlines: Women with a common form of early-stage breast cancer can safely skip chemotherapy without compromising their survival. Now, as many as 70,000 patients a year in the United States may be able to avoid this harsh therapy. We can thank clinical trials for that.

Clinical trials are a niche offering, usually available at NCI academic cancer centers like The University of Kansas Cancer Center. It takes a deep bench of experts, a unique infrastructure and an unwavering commitment to patient safety to conduct clinical trials.

We are fortunate to have a dedicated facility for cancer clinical research, called the KU Clinical Research Center. Designed unlike any other research facility in the region, the centrally located facility has state-of-the-art features to best accommodate clinical trial participants and researchers. These specialized resources include the investigational pharmacy to manage clinical trial medications, a correlative laboratory to process trial samples and a dedicated team of nurses and technicians whose sole focus is caring for patients on clinical trials.

A Clinical Trial for Every Stage of Cancer

Clinical trials are available for patients with all stages of cancer. For example, there are trials comparing different surgical or radiation approaches in the newly diagnosed, setting trials that study different kinds of chemotherapy given either before or after surgery and trials for patients with metastatic disease. In addition to testing new drugs, there are clinical trials to test drugs that are already FDA-approved for one specific disease to study whether it also can be effective for other cancer types.  

Some people may think that an early-phase (phase I) clinical trial is a “last ditch” effort for cancer patients or that these trials can only help patients who have exhausted other treatment options. That is simply not true. Some phase I trials do test a new drug as a single agent in patients who have already received several treatments. However, more often we see combination trials for patients with newly diagnosed or recurrent cancers – combinations of standard treatments with the addition of a new medication – with the goal of improving outcomes from the standard treatment alone.

That’s why you may hear us refer to clinical trials as “standard of care plus,” meaning that the participant is receiving the treatment as he or she normally would, but with a new drug that has shown promise in the laboratory, as well as the added expertise of the clinical trials team.

Clinical trials at KU Cancer Center are not limited to treatment trials. Other types of studies include cancer prevention studies in high-risk populations, screening studies to find cancer earlier when treatments may be more effective and quality-of-life trials designed to minimize side effects of cancer treatments.

Choosing to Participate in a Clinical Trial

Clinical trials have been and will continue to be the process by which new and improved treatments become available to the broader population. Advances in cancer care would not be possible without clinical trials. Nearly every cancer drug available to us was made possible because patients over the years chose to participate in clinical trials. Data from clinical trials have provided critical insights into the biology of cancer and the development of new treatment strategies. It is awe-inspiring to consider the contributions of clinical trial participants. The contributions of these patients have revolutionized cancer treatment.

If you are interested in learning whether a clinical trial is right for you, talk to your doctor.