How clinical trials move cancer treatment forward
COLUMBUS, Ohio (WKRC) - The vision of The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute (OSUCCC – James) is to create a cancer-free world. Clinical trials help the OSUCCC – James pursue that vision by testing targeted methods of preventing, detecting, treating and curing cancer. The OSUCCC – James has hundreds of open clinical trials, many of which are available only at Ohio State. It is also one of only a handful of cancer centers in the country funded by the National Cancer Institute to conduct phase I and phase II clinical trials on novel anticancer drugs.
“Clinical trials are the most important work done at a cancer hospital,” says Bhuvaneswari Ramaswamy, MD, who chairs the Clinical Scientific Review Committee at the OSUCCC – James. “Every drug we use today was once part of a clinical trial, and we are curing more and more people because of (them).”
HOW CLINICAL TRIALS WORK
There are three phases of human clinical trials. Each successive phase addresses a different question. Phase I determines dosage, how the drug should be administered and safety of the drug; this is called a first-in-human trial. Phase II determines whether the new drug has an effect on a certain cancer. Phase III determines whether the drug is an improvement on the current standard of care.
Passing from one phase to the next requires clearing a high hurdle. Every Comprehensive Cancer Center has a Scientific Review Committee like the one Ramaswamy chairs at the OSUCCC – James. The committee is composed of investigators, oncologists, biostatisticians and pharmacists who assess each clinical trial phase for its scientific integrity. For example, is the trial protocol fairly designed? Does it gather enough data? Does it seek to answer a valid question? Is it transparent for the patient? Is it absolutely safe?
If a study passes through all three clinical trial phases, the drug is submitted to the U.S. Food and Drug Administration (FDA) for approval. If the FDA approves the drug, it becomes available for clinical use around the country. The primary benefit to patients who participate in clinical trials is receiving sophisticated cancer treatments not yet available to the public.
There are two most common misconceptions that surround clinical trials. The first is that they are an option of last resort. This is not necessarily the case. At every stage of an individual patient’s journey, whether early or late, cancer clinical trials provide an option, often the best option.
Consider ribociclib, a drug treatment for stage IV breast cancer patients that was developed in collaboration with Ramaswamy and colleagues at the OSUCCC – James. Clinical trials demonstrated that the drug is most effective when it is administered early in the management of metastatic cancer. Hence the patients in those clinical trials received an innovative treatment that no one else could yet receive. The trials also benefited countless future patients by demonstrating how the drug works best.
“There is no way we would have found that this drug works well if patients hadn’t participated in this study,” says Ramaswamy.
The second misconception concerns placebos. Clinical trials use placebos only as an addition to standard-of-care treatment. Participating patients are randomly selected to receive either standard-of-care treatment with the new drug or standard-of-care treatment with placebo.
“At no point,” says Ramaswamy, “would a patient’s outcome be jeopardized by going on a study.”
Enrolling in a clinical trial is a personal choice. Participation is 100-percent voluntary, and participants may leave a trial at any time and for any reason. Anyone entering a trial will receive a full explanation of the study and its potential risks and benefits, but patients also are encouraged to ask their physician about the purpose of the trial and what it entails, why the researchers believe the treatment under study may be better than the standard of care, how participation will affect their daily life, and other questions.
To learn more about what to ask before enrolling in a clinical trial, and other aspects of these studies as well, visit the clinical trials section of the OSUCCC – James website at https://cancer.osu.edu/cancer-specialties/clinicaltrials.
The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is located at 460 W. 10th Ave. on the Ohio State campus. (43210).
To learn more about the OSUCCC – James, visit: https://cancer.osu.edu.