By JOSH TILL

Imagine you have an illness for which there is no approved and available treatment. Your doctor suggests you participate in a clinical trial involving an experimental drug. You are scared. You are stressed. You are overwhelmed with information. This is where UAB’ s Phase I Clinical Trials Unit steps in, giving patients comfort, innovative treatments, and most of all, HOPE.

Clinical trials are the final and crucial step in bridging the gap between the laboratory bench and the patient’ s bedside. Before any new cancer drug can be approved by the U. S. Food and Drug Administration and placed on the market, it must be shown to be safe and effective. This is accomplished through a series of clinical trials.

The UAB Center for Clinical and Translational Science( CCTS) aims to accelerate research for improved human health while making it easier for patients to take part in clinical trials. CCTS research covers every phase of translation – from the first idea, to the first test, to large-scale clinical trials, to moving a proven treatment into health practices and encouraging its adoption as a standard therapeutic approach.

Clinical trials are predominantly conducted in three phases, with phase I trials being the first step in testing a new treatment in humans to evaluate safety, identify side effects and determine safe dosage. As part of that, the CCTS recognized a few years ago the need for a facility at UAB in which patients could receive both FDA-approved and experimental drugs in one centralized location. That place eventually became the Phase I Clinical Trials Unit.

Located on the 15th floor of UAB Hospital’ s Jefferson Tower, the Phase I Unit is a“ one-stop shop” dedicated to conducting all phase I clinical trials at UAB, regardless of the medical specialty or organspecific disease. UAB and the Comprehensive Cancer Center have long been recognized as a national leader in clinical trials, with the Cancer Center currently offering more than 180 cancer-related trials exploring a wide array of therapies, diagnostics and preventive options.

Phase I trials are unique, because they involve drugs never before tested in humans. In these studies, researchers assess the side effect profile of the new drug and its safety profile over a broad dose range as well as gauge its circulation time in the body( pharmacokinetics) and its biologic activity. It takes a specialized team of physicians and staff to conduct such“ first-in-human” studies. Because side effects are also being closely monitored, these studies usually include a limited number of patients who have often exhausted conventional treatment options.

“ Patients who enroll in a phase I trial have often failed all other therapies,” says Mansoor Saleh, M. D., director of the Phase I Program and Cancer Center senior scientist.“ Our patients volunteer to take part in these novel treatment options. It is often a trip into the unknown, and our team is dedicated to giving these patients hope and taking care of them on this therapeutic journey.”

A Dedicated Team

As an institution, UAB has been conducting phase I studies for many years, but in individual interest groups – i. e., breast cancer, colorectal cancer, etc. The beauty of the Phase I Unit is that it brings all of these studies together under one umbrella to be run by a team specifically dedicated to phase I trials. In other

words, a researcher can design a clinical trial, and Dr. Saleh and his team will provide the infrastructure and resources to conduct it.

“ In a phase I trial, we are looking at toxicity and the kinetics of the drug – how long does the drug survive in the patient, are there surrogate markers demonstrating the drug is active, etc.,” Dr. Saleh says.“ Our model is unique in that it allows the investigator to focus on their patient while the phase I team provides all the necessary nursing and specialized resources. This is in contrast to every investigator having to do it for themselves. It is a win-win situation and ideal for the investigator, UAB and for pharmaceutical sponsors who prefer to deal with one team for their early drug development needs.”

Having a core team completely dedicated to phase I studies has had a significant impact on UAB.“ The Phase I Program has been able to identify operational needs and gaps, improve our processes and establish an efficient system that can meet benchmark standards,” Dr. Saleh says. For example, patients no longer have to go to multiple clinic locations for their care while enrolled in a phase I trial. All care, including administration of the experimental agent as well as standard-of-care drugs, can be given in the Phase I Unit in UAB Hospital.

The phase I team has also been able to expedite the time it takes from the receipt of a study protocol to enrolling the first patient on trial, referred to as TTA – Time to Trial Activation.“ We are committed to a TTA of approximately 100 days, a benchmark that would make us a leader in the field,” says Dr. Saleh.

The UAB Center for Clinical and Translational Science( CCTS) aims to accelerate research for improved human health while making it easier for patients to take part in clinical trials.

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