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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