Questions & Answers about Clinical Trials

Questions and answers about participating in a clinical trial

As the associate director of clinical research at the cancer center, Kathy Miller, MD, designs clinical trials to improve the quality and length of patients’ lives.

She’s also one of the country’s leading breast clinical trial specialists, serving as co-chair of the National Cancer Institute’s Breast Cancer Steering Committee where she oversees trials across the country.

Breast cancer expert Dr. Kathy Miller

In addition to her research expertise, Dr. Miller has treated hundreds of cancer patients as an oncologist—and she knows decisions about volunteering for a research study aren’t easy to make. Here’s how she advises patients in the clinic.

How do I know if I’m eligible for a clinical trial—or if my loved one might be?

Each cancer clinical trial has strict eligibility rules about who can and cannot participate. These criteria might include age, a specific type of cancer or biomarker, previous treatments, and other specifications. Those criteria ensure the safety of the study participants while at the same time ensuring that the trial can answer the important question.

You’ll find eligibility requirements in the official description for each study. Your oncologist will help you find the right fit and assess the benefits and risks.

Search Our Database Visit ClinicalTrials.Gov

Without clinical trials, we would have no new cancer therapies. That means accepting that what we have to offer patients right now is the best we’ll ever have. And I can’t accept that.

Kathy Miller, MD — Associate Director, Clinical Research

How will I know what kind of risks I might face?

Before you commit to volunteering for a clinical trial, you’ll go through a process called “informed consent.” It’s more than just your signature on a form—this process ensures every patient:

  • Knows what to expect from treatment and side effects;
  • Understands the study schedule and requirements;
  • Learns about any costs or payments for participation;
  • Has the opportunity to ask questions;
  • Has sufficient time to make a decision.

If I participate in a trial, will I be told of the trial’s results?

In most cases, yes. It’s important to remember that the results of some trials may not be available for several years or more. This is especially true of trials testing new treatments to prevent recurrence in patients with early stage disease.

Will I be told if the treatment is working for me?

Absolutely! We all want and need to know if a treatment is working for you. Patients enrolled in clinical trials are followed closely to make sure their disease is improving or remaining under control and to avoid potentially dangerous side effects.

Will I have to travel to Indianapolis for treatment?

While our cancer clinical trials are conducted by faculty at the cancer center and IU School of Medicine in Indianapolis, we work with dozens of hospitals and hundreds of physicians across Indiana to ensure access to as many patients as possible.

Some large trials may be open at hundreds of centers around the country or even the world, while some smaller trials are available at one or two centers. We’ll talk about how often you’ll need to travel to Indianapolis as part of the consent process.

Some large trials may be open at hundreds of centers around the country or even the world, while some smaller trials are available at one or two centers.

Do I pay to take part in a clinical trial?

In general, no. Treatments or evaluations that would be part of your treatment, even if you were not enrolled in the trial, are charged to you or your insurance company.

However, any treatment or test that is required by the clinical trial is free to the patient. We will explain what is provided and covered by the trial as part of the informed consent process. Some trials may reimburse you for the extra time and travel to the study center.

How are clinical trials funded?

Many trials receive grants from government agencies, especially the National Institutes of Health (NIH) and the National Cancer Institute, and some are sponsored by the pharmaceutical companies we work with.

Philanthropic foundations like the Walther Cancer Foundation and the Vera Bradley Foundation for Breast Cancer also provide direct funding, as do volunteer organizations like 100 Voices of Hope.


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