Cancer Research & Clinical Trials

Clinical trials are a way for us to definitively answer important questions. Clinical trials are typically interventional. That means we test to see if a new therapy or a combination of therapies is more effective than what is normally offered to people with a similar diagnosis as standard treatment.

Every effective treatment available today had to be tested first in a clinical trial. Clinical trials give patients access to new, cutting-edge treatments that aren’t available otherwise. Sometimes, they offer additional resources. For example, some clinical trial sponsors help with travel to and from appointments. Within the Froedtert & MCW Cancer Network, patients with specific needs have access to the clinical trials patient navigator, Adrena Luckett, who sends patients appointment reminders and asks if they have any transportation issues. This helps ensure patients complete their intended therapy.

There is also the helping component of a trial. Some people derive satisfaction knowing that participating in a trial helps identify better treatments for future patients.

A tremendous amount of work goes into the careful design and review of a clinical trial. It often takes years of reviewing the data and science to even propose a trial. Additionally, the trial must go through regulatory agencies and ethics committees. By the time a clinical trial is approved, we are confident it is a safe trial.

While clinical trial availability is not limited to academic medical centers, clinical trials require many resources to be conducted safely and effectively. Academic medical centers typically have these resources: appropriate facilities, including lab space; a high volume of patients to participate in trials; administrative and budget oversight; a well-organized clinical trials office; and the ability to closely monitor and report results transparently. Importantly, designing and conducting clinical trials requires the ability to attract experts — physicians and researchers who are specialists in their fields and passionate about finding better ways through research to help their patients overcome cancer.

When we enroll patients in a clinical trial, we very clearly tell them that if, at any point, they want to withdraw from the trial, they can. We then help them withdraw safely and ensure there are no breaks in their cancer care.

There is no direct cost to the patient to participate in a clinical trial, but patients may pay for the standard care they would have received outside the trial. For example, some lab tests and imaging may involve out-of-pocket costs like routine copayments. People should let their health care team know if trial-related costs are a burden for them.

There are many. One of the most memorable for Dr. Clarke was a clinical trial of imatinib, a targeted therapy for gastrointestinal stromal tumors. These tumors did not respond to chemotherapy or radiation therapy, so there was no beneficial option other than surgery for people with advanced disease. Imatinib is a daily pill. When Dr. Clarke was a medical student, she met a patient who had that cancer and was on hospice when the imatinib clinical trial opened. The patient participated in the trial and eight months later, was living a normal, healthy life. Based on trial results, imatinib is now routine treatment for these tumors.

Common barriers are transportation, housing (a patient may be unhoused or staying with relatives) and childcare. It can be difficult for patients to get to appointments on time. As the clinical trials patient navigator, Adrena works to eliminate barriers so cancer care can be the patient’s top priority.

We encourage patients to ask their doctor if there is a clinical trial that would benefit them. Matching patients to trials is complicated. Anai Kothari, MD, MS, surgical oncologist and MCW researcher, is piloting a platform that uses data science and artificial intelligence to match eligible patients with clinical trials available within the Froedtert & MCW Cancer Network.

It is part of our mission to decrease the cancer burden for all our communities. We want to ensure clinical trials are available to everyone who can benefit from them. Every cancer diagnosis is unique, and we want to ensure patients are matched to the clinical trials that are most beneficial to them. Some treatments may not be effective for everyone. If those variations aren’t reflected in trials, treatments may not be as effective for everyone. Our clinical trials patient navigator works with patients to help them understand what a clinical trial is, answering questions and tackling any barriers they face or reservations they may have about participating.