In recent years, a great deal has changed in clinical trials for cancer care — and the patients who enroll in them.
“It used to be that clinical trials were offered only to cancer patients who had exhausted all other therapeutic treatment options,” says Edward Chu, MD, chief of the Division of Hematology-Oncology and deputy director of the UPMC Hillman Cancer Center.
“That is no longer the case. With genetic sequencing, we now can identify mutations and/or alterations in a patient’s specific cancer and use a targeted therapy or immunotherapy drug to treat that exact mutation. We believe the drugs that target specific mutations offer the best hope for patients.”
Clinical trials are incredibly valuable to both researchers and patients. Investigators use clinical trials to test new drugs and therapies that treat a wide range of human cancers.
“The goal of clinical trials is to extend patients’ lives, help manage their symptoms, or reduce side effects from various treatments,” explains Dr. Chu. “All treatments in use today and considered to be standard of care treatments were once part of clinical trials. We try to offer patients a clinical trial for every stage of disease so they benefit of the latest research.”
The Phases of Clinical Trials
There are three phases of clinical trials:
- Phase 1 trials are for first-time testing of new agents and/or combination treatments. The goal of these studies is to establish the proper dose and schedule. At UPMC, Phase 1 trials are only offered at UPMC Hillman Cancer Center at UPMC Shadyside.
- Phase 2 trials are for testing of new agents and/or combination treatments that look safe and promising based on the Phase 1 trials. The goal is to confirm the clinical efficacy of these new therapies as well as to provide further information on their safety. At UPMC, these trials are offered at in the community at our hospital-based cancer centers.
- Phase 3 trials compare new agents and/or combination treatments to the standard of care treatments. These trials are offered at UPMC Hillman Cancer Center at UPMC Shadyside and at cancer centers in other UPMC hospitals.
The Purpose of Clinical Trials
Clinical trials are critical in moving promising new drugs from the research stage to the patient’s bedside.
“In the past, clinical trials used to take 10 to 15 years before drugs were approved by the Food and Drug Administration (FDA) for treating patients,” Dr. Chu says.
“Now drug approvals have accelerated to where it may take only about one to three years to move from Phase 1 testing to FDA approval for use every day in clinical practice.”
What Happens When You Enroll in a Clinical Trial
Patients who enroll in clinical trials undergo a thorough evaluation to ensure they meet the study’s eligibility criteria, including blood work, a past medical history, normal organ function, and imaging of their tumor.
Once enrolled and receiving the drug, patients are assessed regularly to ensure that side effects are minimal, they are tolerating the treatment, and the cancer is responding to the treatment.
Paying for clinical trial medicine should not be a concern for patients, says Dr. Chu, as standard-of-care drugs are typically covered by insurance.
“The cost of experimental drugs is covered by the clinical trial, as is the cost of any extra imaging studies and blood tests that are needed,” adds Dr. Chu. “There should be minimal out-of-pocket costs to patients enrolled in clinical trials.”
If you are a patient who has been offered a clinical trial, Dr. Chu suggests that you have an open discussion with your oncologist.
“Research has shown that many of these new treatments are helping patients live longer,” says Dr. Chu. “In 2018, early phase clinical trials provide tremendous hope even for patients who have been heavily treated with standard treatments, and we are now seeing impressive responses with these newer therapies.”