Discovering new cancer treatments through clinical trials
It was 1983, and the first time Muriel Worth of Mt. Holly was in a hospital since the birth of her youngest son. This time, however, her visit was less joyous. Worth, an otherwise healthy woman of 65, was beginning treatment for early-stage breast cancer. That's when her medical oncologist told her about a promising new therapy. But it was only available through a clinical trial.
"I don't think I ever heard about clinical trials before I was asked to participate in one," recalls Worth. "After my doctor explained clinical trials and what it means to take part, my husband and I decided it was the right thing to do. After all, if people like me don't take part in clinical trials, how will they ever learn the best ways to treat cancer?"
Investigating new treatments
Clinical trials, such as the one Worth participated in, are voluntary studies that investigate new ways to prevent, diagnose and treat cancer. Patients who participate in these studies gain access to the most recent approaches in cancer care, developed by the nation's foremost cancer specialists. Many of today's standard treatments for cancer began as clinical trials.
"Clinical trials are critical to the advancement of science," explains
Ashok Bapat, MD, medical director of the
Fox Chase Virtua Health (FCVH) Cancer Program at Virtua West Jersey Hospitals. "The goal is to improve the outcome of a given illness, and to find out if new treatments are better than the standard of care."
At the time Worth participated, the standard of care for patients with her disease was surgery followed by 12 months of chemotherapy. The clinical trial she agreed to participate in compared this standard of care with a treatment of four months of chemotherapy with and without tamoxifen — a new drug that showed promise in reducing the recurrence of breast cancer. While the standard of care has continued to evolve, now tamoxifen is used regularly in breast cancer treatment. This advancement is a direct result of the information that was gathered from this and other clinical trials.
How clinical trials work
The trial Worth participated in was considered a Phase III trial. Clinical trials fall into four phases with each building on information gained from the previous trial. Phase I trials involve a small number of patients testing a new therapy for safe dosage and side effects. Phase II include a slightly larger group of participants and test whether the Phase I treatment is effective in treating the disease.
Phase III trials involve more than 100 participants. These compare treatments of proven efficacy against one another or against the existing standard treatment. "By design, no patient is expected to be treated with a modality that is hypothetically less than the standard of care when on a Phase III trial," says Dr. Bapat who serves as a principal investigator for FCVH Cancer Program at Virtua West Jersey Hospitals. "On occasion, early in the course of a clinical trial, researchers may find one treatment to be vastly superior or inferior to the other. If this happens, they are obligated to modify the clinical trial. Thus, the researcher will stop the less effective treatment or make the superior treatment available to everyone."
Phase IV clinical trials are reserved for successfully proven treatment options that are approved by the Food and Drug Administration. These trials are developed to answer other questions about the treatment including risks, benefits and optimal use.
Safeguards protect patients
While there are no guarantees in a study, there are safeguards to protect patients.
Michael Entmacher, MD, FCVH medical oncologist, says that the most important safeguard is the Institutional Review Board (IRB). "The IRB is a group of clinicians, members of the medical staff and members of the community who review studies before they are offered to patients," explains Dr. Entmacher. "The IRB does everything possible to ensure the patient's safety and make certain that a trial's potential benefits outweigh the risks." This group also monitors the progress of the studies.
"Virtua has participated in hundreds of clinical trials over the years," says Dr. Entmacher, who has served as a principal investigator for Virtua Memorial Hospital for more than 20 years. "We select trials that best meet the needs of the community and enable us to offer today's cutting-edge treatment options."
If you are interested in participating in a clinical trial, see a list of the
trials offered through FCVH. For a free information sheet on clinical trials, call
1-888-Virtua-3.
Meet the physicians
Ashok Bapat, MD, completed a residency at St. Francis General Hospital in Pittsburgh. He completed two fellowships including one in hematology at Thomas Jefferson University Hospital and another in hematology-oncology at the University of Medicine and Dentistry of New Jersey. He has been treating cancer patients for almost 20 years.
Michael Entmacher, MD, earned his medical degree from Duke University School of Medicine in Durham, North Carolina. He completed a medical residency at Ohio State University Hospital as well as a fellowship in hematology-oncology at the Duke University Medical Center.