The anatomy of a clinical trial

Clinical trials serve as the bridge between research and patient care. Learn more about clinical trials, who can participate and why they play a vital role in cancer research.
Written by: Anna Waters
Media contact: Yvonne Taunton

Clinical Trial StreamClinical trials serve as the bridge between research and patient care. Learn more about clinical trials, who can participate and why they play a vital role in cancer research. clinical trial is a special kind of research approach that physicians and scientists use to study the effects of a new treatment in order to compare it to an existing treatment. If the new treatment proves to be safer or more effective than the current standard treatment, it can become the new standard of care for treating people with cancer.

Clinical trials represent the culmination of a long, rigorous process by which physicians and researchers translate promising scientific findings from the laboratory into medical practice so those findings can become new treatments for a disease.

As researchers ask questions about how cancers develop in the human body, they can use the results of their research to develop potential treatments for cancer that can challenge the bodily processes upon which cancers depend. These potential treatments are then tested in clinical trials where they are offered to cancer patients. Clinical trials are a vital component of this “bench-to-bedside” model that defines the field of translational science, representing the bridge between scientific research and patient care.

Barry Sleckman, M.D., Ph.D., director of the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, says its NCI designation and diverse clinical trials portfolio differentiate the Cancer Center from other cancer care providers in the state.

“Today, many patients on clinical trials are experiencing remarkable, disease-altering effects on cancers that were uniformly lethal just yesterday,” Sleckman said. “For this reason, offering cancer patients clinical trial opportunities is really the standard of care for cancer.”

How do clinical trials work?

The treatments that are tested in clinical trials must be studied carefully and evaluated in large, diverse groups of people over long periods of time before they can be officially offered to the public as the standard of care. But if a new treatment does prove to be effective, trial participants could be among the first to benefit from it, especially if their cancer is not responding to existing treatments.

Doctors decide whether a patient is eligible for a clinical trial depending on the patient’s specific kind of cancer, current condition and individual needs. If doctors believe a patient might benefit from a new treatment offered by a clinical trial, they will give the patient the choice to enroll.

“If you are diagnosed with cancer and aren’t sure what to do next, it’s OK,” Sleckman said. “You don’t have to know exactly what to do. You need to know where to start. At the NCI-designated O’Neal Comprehensive Cancer Center at UAB, you have access to the best multidisciplinary cancer care and the latest cutting-edge trials.”

Patients participating in a clinical trial receive the new, experimental treatment or, at the very least, the best available existing treatment for their cancer. Patients who receive the existing treatment typically still benefit from it as they would have if they had received it outside of the trial.

What is in a phase?

Clinical trials are conducted in at least three phases, each of which seeks to answer different questions about a new treatment. It can take a long time for a trial to move from one phase to another, which means it might be years before a treatment is officially approved by the Federal Drug Administration.

In Phase I trials, physicians and scientists learn how a new treatment should be administered, what constitutes the optimal dose and schedule, and how the treatment affects the human body.

Phase II trials focus on how the treatment affects a specific type of cancer in larger groups of people. Then, if treatment shows promise in Phase I and Phase II, it is tested in a Phase III trial, where physicians and scientists work to confirm its effectiveness, monitor any potential side effects and compare it to the existing standard-of-care treatments for that specific type of cancer. Phase III trials are large-scale studies that can include hundreds or even thousands of people.

Who participates in clinical trials?

Despite the O’Neal Comprehensive Cancer Center’s push to expand its Clinical Trials Office and increase trial enrollment, only 3 percent to 5 percent of adult cancer patients in the United States participate in trials, according to Oncology. Demographic data also indicates that cancer patients who enroll in clinical trials, both in and outside the United States, are more likely to be younger, male and white.

“Offering patients the opportunity to enroll in clinical trials as part of their overall treatment plan is just one example of what the O’Neal Cancer Center can do through its cancer services to give patients a genuinely comprehensive experience,” Sleckman said. “Clinical trials are now the standard of care for cancer, and they can and should be offered to every patient at UAB who could benefit from them.”

Sleckman says it is imperative that patients understand the lifesaving potential of these clinical trials, as well as the many other cancer therapies and treatments that are available at UAB.

The O’Neal Comprehensive Cancer Center is committed to offering its patients a diverse array of high-value clinical trials with potential disease-altering impact.

The O’Neal Trials program invests in building the Cancer Center’s clinical trials portfolio and training junior clinical faculty at the O’Neal Comprehensive Cancer Center to become nationally recognized clinical trialists.