The 2009 Annual Report highlighted HCI’s new Center for Investigational Therapeutics (CIT) and phase I clinical trials. With the CIT’s streamlined clinical trial process, the phase I and I/II program led by Sunil Sharma, MD, HCI senior director of Clinical Research and a professor in the University of Utah’s Department of Internal Medicine, “has experienced tremendous growth,” according to Brad Bott, associate director of HCI’s Clinical Trials Office (CTO).

Phase I clinical trials are the first step in testing new treatments in humans. They test the best way to give a new treatment and the best dose. Phase I/II trials study the safety, dosage levels, and responses to a new treatment.

From the time Sharma arrived in July 2009 to the end of the year, the CTO opened seven trials in the two categories. “During 2010, we activated 19, six of which are ‘first-in-man’ studies,” said Bott. In first-in-man studies, drugs and medical procedures—previously assessed through mathematical modeling, in vitro, and animal testing—are given their initial testing in humans. “In 2009, the CTO enrolled 95 HCI patients on phase I and phase I/II clinical trials compared to 189 in 2010,” Bott adds.

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Brad Bott and Sunil Sharma, MD

In addition to increased phase I and I/II enrollments, HCI has advanced its overall clinical trials program. Approximately 16% of HCI patients are currently enrolled in therapeutic clinical trials. This compares to a national average of less than 5% reported by the National Cancer Institute. Also in 2010, HCI implemented the OnCore clinical trials management system. It tracks, manages, and centralizes clinical research data and processes.

“Since investing in and implementing the phase I program in July 2009, HCI has made significant progress in developing clinical trials,” says Sharma. “Clinical trials allow us to provide our patients with additional options for continuing their treatment while advancing research that can improve the hopes of future patients.”

Read the 2009 Annual Report story Investigational Therapeutics Offer the Last, Best Hope.

The Phases of Clinical Trials

Phase I trial: The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. Because little is known about the possible risks and benefits of the treatments being tested, Phase I trials usually include only a small number of specific patients.

Phase I/II trial: A trial to study the safety, dosage levels, and response to a new treatment.

Phase II trial: A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

Phase III trial: A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

Phase IV trial: After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial.