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The Teams That Make Clinical Trials Possible

By Natalie Streeter, Assistant Vice Chancellor, Clinical Research, Strategy and Operations
woman with long brown hair holds a sign that says "we are innovative, dedicated, changing lives"

May 15, 2023

Clinical Trial Awareness Day is May 20th and this week, The University of Kansas Cancer Center is hosting several events recognizing the importance of clinical research, as well as celebrating the incredible efforts of our clinical trial team members. The cancer center employs more than 180 staff members and 75 oncologists who are dedicated to conducting clinical research to prevent and treat cancer. We offer clinical trials at all KU Cancer Center sites and across Kansas and western Missouri.  

Clinical trials are research studies that look at the way new medications or therapies work and if they are effective at treating or preventing the problem being studied. This could be anything from headaches to asthma to high blood pressure to cancer.  Clinical trials are crucial to helping us develop new ways to treat disease.  
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The birth of clinical trial research

The first clinical trial is thought to have been conducted aboard a ship in 1747, at a time when scurvy was rampant. It is believed that scurvy killed about 2 million sailors between the 16th and 18th centuries. Aboard this ship, surgeon mate James Lind, a pioneer of naval hygiene, had a hunch that scurvy was caused by decay of the body, and that it could be cured through the introduction of acids.  Lind recruited 12 men for his “fair test” and gave some of them citrus fruits.  Those given citrus fruits experienced “the most sudden and good visible effects,” according to Lind’s report on the trial. Today, we know that scurvy is a dietary deficiency caused by a lack of vitamin C, and citrus fruits are rich in the vitamin. Clinical Trials Day is celebrated around the world to recognize the day that James Lind started what is often considered the first randomized clinical trial.

The field of clinical research has made a lot of progress in 275 years, but in the field of cancer we still have a long way to go. At KU Cancer Center, our goal is to have a research option for every patient we see.  Research is completely voluntary, and people can choose to participate or withdraw at any time. Considerable time is spent on patient education about treatment options so that our patients are aware of all alternatives. Research is the key to find better treatment options for patients, as well as identify better ways to manage the side effects of cancer, live longer with cancer, and hopefully, prevent cancer.

Behind the scenes

At any given time, the cancer center has nearly 600 studies in various stages.  What our patients don’t see are the hundreds of people working behind the scenes. It takes a robust infrastructure and team of experts to carry out clinical trials.  Cancer studies are highly regulated to make sure patients are kept safe and so that researchers have accurate information to drive decisions about what new drugs should be approved for use in the future.  We have 12 main teams. Each is crucial to helping patients get access to new treatments.
  • Clinical Operations: These staff educate patients on the study, meet with the physician and patient at visits, help schedule and coordinate needed tests and treatments and stay in close contact with the patient throughout the study.
  • Clinical Data: These staff comb through medical records and record key pieces of information that will be used by safety teams, scientists and statisticians to decide if treatments are working.
  • Pre-Screening: This team works with our physicians to identify studies that may be an option for a patient. The physician will then work with the patient to select the best treatment.
  • Regulatory: These staff work to make sure that patients have the most up-to-date information, that we are conducting research by the ethical principles, and work with all teams to meet the legal guidelines.
  • Quality Assurance: These staff conduct audits and review study safety.
  • Finance: These staff help us budget our research efforts.
  • Training and Education: This team helps us train our staff on the details, policies and procedures to conduct clinical research. They train all new staff as well as provide continuing education to staff.
  • Lab: We learn a lot about how medications work from studying things such as blood, urine, biopsies, stool, etc.  We also use these tests to keep patients safe. Patients consent to give specimens.
  • Research Systems: Research data is crucial to understanding what we are learning in these studies and this team manages all the databases and tools researchers use to analyze and capture data.  Data is highly regulated to protect patient privacy. 
  • Site Development: This team works with our doctors and scientists to understand what kinds of treatments our patients need and then help find studies offering the new treatment and bring them to KU Cancer Center.
  • Project Management: This team manages the entire process from an idea about a study to getting the first patient treated. They work with the other clinical trial teams, in addition to pharmacy and legal teams.
  • Research Administration: These are the people leading and supporting all the teams above and working with cancer center director Dr. Roy Jensen to carry out his vision for cancer research.

Even though a patient may interact with just a few people throughout their clinical trial experience, there are dozens of people at work, ensuring the process goes smoothly. Clinical trials require the expertise of many individuals to be successful.  

Download the cancer center’s Clinical Trial Finder app

Our app helps people find ongoing trials that might aid their current treatment. The app is available for iOS and Android users. To download, go to the App Store or Google Play Store and search for "KUCC Clinical Trial Finder." From there, download the app to your personal device.


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