Four Things to Know about Clinical Trials

4 things everyone should know about clinical trials

Clinical trials are research studies in which people with either a high risk for cancer or diagnosis of the disease help physicians find ways to improve health and cancer care.

What can clinical trials really do for cancer patients and researchers? Tim Lautenschlaeger, MD, medical director of the cancer center’s Clinical Trials Office, shares a few facts that he thinks everyone should know.


Without clinical trials, we would have no new cancer therapies.

Laboratory studies can only reveal so much and take the search for a cure for cancer so far. Many treatments that look promising in the lab don’t work when tested in people. Some drugs may be metabolized differently or have different side effects based on a patient’s racial or ethnic background.

If we couldn’t test safety and effectiveness on a wider scale, with a diverse population, we wouldn’t be able to recognize and understand those differences.

Every advance in cancer that you will read and hear about in the next five years is available today, but we need patients to participate in the clinical trial.

Dr. Nasser Hanna — Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research

Every new cancer therapy goes through three phases of clinical testing.

Phase I clinical trials study the safety of a new treatment. Phase I studies enroll only a small number of patients and follow patients closely. Once researchers know a treatment is safe and understand the dose and schedule, they move to phase II.

Phase II evaluates efficacy—how well a treatment works in certain patients. For example, there may be a phase II trial in patients with previously treated lung cancer and a separate phase II trial in patients with kidney cancer.

Phase III compares the new treatment to the best currently available treatment.

Chemotherapy is just one type of cancer clinical trial.

When you look at a listing of clinical trials, you’ll see the names of dozens of new chemotherapy drugs. While pharmaceuticals make up a large percentage of current trials, our researchers are also investigating new treatments and techniques for radiation, surgery, high-tech imaging, immunotherapy, and more.

In addition, IU is gaining national prominence in the growing field of survivorship—the long-term impact of life during and after cancer treatment. Our experts are testing side effects like cognitive issues (the infamous “chemobrain”), nerve damage, hearing impairment, and muscle loss.

People of color are significantly underrepresented in clinical trials.

From genetic vulnerabilities to debilitating side effects, Black patients face unique barriers in detecting and surviving breast cancer, multiple myeloma, and other diseases.

Other populations can have similar negative outcomes due to completely different causes. If we don’t have a diverse population in the trials, we can’t recognize and understand those differences.

No one wants cancer, but if you are diagnosed, you want the best treatment available. I feel like I was able to experience that.

Sandra Chapman — Breast cancer survivor and clinical trial participant


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