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New Therapies and Drug Trials

Clinical Trials Provide More Options for Cancer Care

Discovering Better Ways to Treat Patients

Cancer is the uncontrolled growth of cells that can invade normal parts of the body and spread to other parts of the body. There are more than 100 types of cancer, with an estimated 1,735,350 cases diagnosed in 2018 alone.

In order to better serve patients, Northwestern Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University and Northwestern University Feinberg School of Medicine utilize clinical trials to seek improved outcomes. Maha Hussain, MD, FACP, FASCO, medical oncologist and deputy director at Lurie Cancer Center, says, “Applied medicine is a combination of evidence, science and clinical experience. As leading experts, we are very involved in developing clinical trials and testing leading-edge treatment.”

The Purpose of Clinical Trials

Clinical trials were first introduced in 1025 AD in Avicenna’s The Canon of Medicine, in which he laid down the rules for experimental use and testing of drugs. Although medicine has come a long way, the intent is still the same: Develop the best treatments for patients.

Northwestern Medicine currently is conducting more than 4,500 clinical trials, investigating a wide range of conditions. Each trial’s purpose is to answer a specific question in order to improve patient care. Ultimately, the goal is to discover more effective, less risky methods to treat patients and manage health conditions.

Clinical trials are designed to address specific needs across the spectrum of a certain type of cancer, including situations where there aren’t any other effective treatment options, explains Dr. Hussain.

Robust research is what will conquer cancer.
— Maha H. Hussain, MD, FACP, FASCO

Before creating a clinical trial, clinical scientists must conduct an extensive review of prior investigations. They identify the current standard treatment, evaluate past unsuccessful trials and assess the reasons for failure. They also must understand weaknesses in existing treatments for the disease.

“Our subspecialized multidisciplinary teams meet to discuss gaps and unmet needs, and develop clinical trials. In addition to trials our investigators design, they have access to National Cancer Institute clinical trials, and collaborate with another institution or scientific entity for the best clinical trials to bring to our patients,” Dr. Hussain says.

Weighing the Risks

The process for conducting clinical trials is extremely rigid and tightly regulated for patient safety by the Institutional Review Board, the Lurie Cancer Center Data Safety and Monitoring Committee and the U.S. Food and Drug Administration. “Ultimately, our goal is to ensure safety of the patient and the integrity of the process,” says Dr. Hussain.

As with any procedure or treatment, risk is an important factor to consider.

“Any intervention has risks, even routine procedures. Potential risks are explained and written down for the patient. There’s very close monitoring and, depending on severity, therapy might be adjusted or stopped if medically unsafe or ineffective,” says Dr. Hussain.

In certain trials, a placebo (an inactive drug or other treatment approach) may be used with some participants. This provides a control group in order to measure the effectiveness and safety of the active experimental treatment. Participants are informed if placebos are used in their particular trial, and the information will be provided in the consent form. However, to maintain integrity of the data, neither the treating physician nor the participants know if the participant is receiving the placebo or the active treatment.

Certain risks and side effects of some treatments are known, such as suppressing bone marrow function with chemotherapy. However, the complete risk may not be entirely known. Regardless of the type of side effect, physicians and their team closely monitor participants and have protocols in place for dosage adjustments in order to minimize risks. “The priority is to maximize the benefit versus risk ratio, and minimize side effects as much as possible,” explains Dr. Hussain. When the risk significantly outweighs the potential for benefit, it’s “unacceptable risk” and the trial will not move forward.

Taking the Next Step

After diagnosis of illness, Northwestern Medicine physicians discuss with patients next steps and the options for treatment, including standard care and available clinical trials.

“I discuss in details the standard of care treatment options, expectations and offer all options including clinical trials when they’re at a crossroad. I prioritize the options based on their value and opportunity based on totality of the available evidence, including if any standard of care options are available, clinical and scientific rational ,” says Dr. Hussain. “I always recommend that the patient take some time to think about the choices and let us know preference. Seeking a second opinion is always an option a patient can consider. Ultimately, our goal is to serve patients and make sure they’re very well informed so that they are comfortable with their decision.”

If you are interested in participating in a clinical trial, federal law requires most health insurance plans to cover associated standard of care costs. However, policies may vary.

Changing the Field of Medicine

“We all get into medicine for different reasons, but the most common overarching cause is primarily to make a difference for people. My goal is to make life better, longer, and to minimize physical and mental suffering for patients and their families,” says Dr. Hussain.

Patients have a key role to play in this quest as well, and Dr. Hussain notes the generosity and thoughtfulness of individuals who participate in clinical trials. “Patients are very generous, and their first reaction many times is, ‘I want to help others,’” she says.

Medical research has significantly improved health and reduced mortality. Research has led to life-changing and curative advances like the development of antibiotics to treat infectious diseases such as bacterial infections, tuberculosis, and syphilis. Significant strides have been made in cancer care, such as treatment for testicular cancer, a curable disease even after it spreads. Dr. Hussain adds, “There are numerous stories, with advanced breast, lung, prostate and colon cancers and many types of blood cancers, in which the field has developed impactful, life-prolonging and potentially curative treatments.”

According to the National Center for Health Statistics, cancer mortality is decreasing. “We are curing more cancers and prolonging life in many cancers because of the research across the spectrum that led to discoveries of impactful procedures or treatments,” Dr. Hussain explains.

But research is a never-ending quest. “We continue to be part of the process of discovery and research that leads to better therapies, and part of the scientific teams that are leading efforts to test better treatments with the goals of prolonging life, minimizing suffering and death, enhancing survivorship and ultimately curing cancer,” says Dr. Hussain. “Robust research is what will conquer cancer.”

Maha H. Hussain, MD
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