Thinking About A Cancer Clinical Trial? What To Ask First

If you or a loved one has cancer, you might wonder whether a clinical trial is worth considering. These research studies test new treatments that could improve outcomes—but they also raise important questions about safety, cost, travel and what to expect.

A Franciscan Health clinical research manager answers common questions patients have about cancer research studies and clinical trials.

Key Takeaways: Clinical Trials

• Clinical trials offer access to promising new cancer treatments that are not yet widely available while helping researchers improve future cancer care.
• Clinical trials follow strict safety standards, include detailed informed consent and allow participants to leave at any time for any reason.
• Research studies are available for many stages of cancer care and may provide treatment options alongside or even before standard therapies.
• Investigational drugs and study-related procedures are typically covered by the study sponsor, while routine care is generally billed to insurance.

What Are Clinical Trials?

Clinical trials are research studies in which patients volunteer to test a new medicine or procedure. They are a vital tool for improving healthcare, especially cancer treatment. Every new drug or therapy must go through this process before it becomes widely available.

Franciscan Health Cancer Centers across Indiana offer dozens of clinical trials for qualified patients. These studies give patients access to promising treatment options while helping researchers advance cancer care.

Why Consider A Cancer Clinical Trial?

“We offer many of the same trials under investigation at medical centers and often some that are not offered at these larger institutions,” said Cindy Stoner, BS, CCRP, Oncology Clinical Research Manager at Franciscan Health Indianapolis. “We closely monitor participants, so that we may be able to identify and treat any side effects faster than if they were not on a trial.”

When you join an FDA-approved clinical trial, you have access to:

• Advanced treatment options and promising investigational interventions that are usually not available outside the clinical trial
• An intervention that may be more effective than standard therapy (you may be one of the first to benefit)
• Board-certified physicians and experienced registered nurses, phlebotomists and other support staff
• Investigational drugs and, sometimes, standard care provided at no cost

But before you decide to join a clinical trial — for cancer or another condition — you’ll want answers to important questions. We talked with Stoner to get some of these details for you and your family.

What Are The Phases Of A Clinical Trial?

Every clinical trial has four phases. These stages are:

Phase 1: Safety and Dosage

Phase 1 of a clinical trial determines treatment safety. It also identifies the best dose or regimen for a new medication or therapy. It usually lasts several months.

Phase 2: Effectiveness and Side Effects

During the second phase of a clinical trial, researchers identify side effects and determine whether the medication or therapy successfully treats the cancer. This phase can last between several months and two years.

Phase 3: Confirming Treatment Effectiveness

To confirm safety and efficacy, researchers compare the new cancer treatment to standard care options or placebos. This stage may last between one and four years.

Phase 4: Long-Term Monitoring

Once the new cancer treatment is widely available, this stage evaluates the long-term benefits, effects and safety. This monitoring process can last several years.

Why Should I Participate In A Cancer Research Study?

When you participate in a cancer research study, you play an active role in bringing a new, more effective treatment to patients. You receive access to cutting-edge treatment options and help investigators understand how a medication or therapy works for a group of patients.

“Clinical trials often give a patient hope when they may feel they have limited treatment options,” Stoner said. “Some would argue that you get better care in a trial because you are closely monitored and have a research coordinator who follows your care alongside your regular medical team.”

If you join a cancer research study, you also may receive more customized care. In recent years, cancer clinical trials have focused more on the development of treatment options that can be personalized to a patient’s needs.

“We now talk about precision medicine and therapy tailored to an individual. We can look at a group of patients who respond to a treatment or don’t respond to find what they have in common,” Stoner said. “This helps us make better treatment recommendations for patients in the future.”

Are Cancer Clinical Trials Free?

In most cases, patients do not pay to participate in cancer research studies.

“The study sponsor or research site covers the cost of any investigational drug or procedure. It is not billed to insurance,” said Stoner, who has worked in clinical research since 1998. “Medicare or private insurance typically covers the cost of routine care. So, there shouldn’t be an increased cost to the patient who participates in a trial.”

Can I Leave A Clinical Trial?

Yes, you can leave a clinical trial at any time and for any reason. If you no longer want to participate, talk with the research coordinator or medical team.

“We’ll never suggest something that’s not in the patient’s best interest just because they are in a trial,” Stoner said. “If it’s best for them to come off the trial to pursue other treatments, they come off the trial.”

Are Clinical Trials Only Available In Academic Medical Centers?

No, clinical trials are not only available at academic medical centers. As a Franciscan Health patient, you have access to national research studies, including ones supported by the National Cancer Institute.

“Franciscan Health has some trials that large academic medical centers may not have,” Stoner said. “We consider our patient population when we select which studies to participate in. Study sponsors ask us to participate in trials based on our ability to enroll patients and follow regulations, regardless of whether we are an academic center or community hospital.”

The cancer research teams at Franciscan Health Mooresville, Franciscan Health Indianapolis, Franciscan Health Lafayette East and Franciscan Health Michigan City Woodland Cancer Center lead these clinical trials.

Should Cancer Patients Be Concerned About Privacy In Clinical Trials?

Clinical trial leaders take several steps to protect your privacy and safeguard your protected health information (PHI) during a research study. They remove all identifying information and don’t share personal details with study sponsors.

“We hear some concerns about privacy when we talk about molecular testing to develop targeted therapies. If genetic testing results reveal a gene linked to cancer or another inherited disease, patients and family members often worry how those outcomes may affect their ability to find employment or health insurance,” Stoner said. “But we take extra measures to protect your privacy.”

For example, there are protections in place, such as the Genetic Information Nondiscrimination Act.

Are Clinical Trials A Last Resort?

No, clinical trials are not always a last resort. They can be an option for patients who do not respond to standard therapies. And they also test new treatments that may become first-line care options.

Clinical trials can occur in and focus on any of the four stages of cancer. Trials can also have different objectives, Stoner says. These include:

• Data collection
• Evaluation of new treatment options
• Observation
• Testing new ways to use existing treatments

If you have questions about a clinical trial, its focus or your treatment options, discuss your concerns with your doctor.

“Don’t be afraid to ask questions, discuss with your family and bring questions back to the doctor and research team,” she said. “You should make informed choices.”

Before you join a clinical trial, you must sign an informed consent document. This form explains:

• Expected benefits
• Foreseeable risks
• Purpose of the trial

Connect With A Nurse To Join A Trial

Franciscan Health Oncology Nurse Navigators are registered nurses with special training in cancer care. As your personal guide and advocate, they are by your side at every step of your cancer journey.

In addition to supporting you through a clinical trial, our Oncology Nurse Navigators provide:

• A single point of contact for your care team
• Assistance with timely appointments, insurance issues and access to resources
• Education and information about your diagnosis, treatment options and care plan
• Emotional support and encouragement

Frequently Asked Questions: Clinical Trials

In a cancer trial, would I get a placebo instead of the medicine I need?

Researchers rarely use a placebo alone in cancer clinical trials. Instead, they typically add them to standard treatment. If your trial uses a placebo, the informed consent document will clearly explain it.

Are clinical trials dangerous?

An official Institutional Review Board reviews, approves and monitors every study for safety. This committee stops the trial if the new medication or treatment presents risks that outweigh the benefits. Additionally, you can withdraw from a clinical trial at any time.

Are clinical trials are expensive to be part of?

Clinical trials rarely pass costs along to participants. If you have expenses related to the study, such as childcare, hotel, parking or travel, researchers typically reimburse you. The clinical trial sponsor assumes the cost of any investigational drug or procedure, and Medicare or your insurance company typically covers any routine medical care during the trial. Before you enroll, check with the clinical trial team and your insurance provider to determine your insurance coverage.

Why hasn’t my doctor shared information about a trial that could help me?

Your doctor may not tell you about a clinical trial that could help you. They are not always aware of all open research studies. If you are interested in joining a clinical trial, you can search the National Institutes of Health database — ClinicalTrials.gov — for studies you may qualify for. If you find one, you can reach out to the research team for details. The Clinical Research Programs and Services Education Center can also answer your questions.