Cancer experts at Holden Comprehensive Cancer Center are hopeful that a new Iowa law will help more patients with cancer take part in clinical trials. George Weiner, MD, director of Holden Comprehensive Cancer Center at University of Iowa Hospitals and Clinics, talks about what this new law means to Iowans with cancer:
What is a clinical trial?
A clinical trial is a way to test treatments or other approaches to providing care to figure out scientifically what approach is best. Very often, the doctor would base the treatment they chose on their own experience, which sometimes is just with a small number of patients. A clinical trial allows us to put science behind this and rigorously compare one treatment to another so that the better treatment is the one that we use moving forward.
Why are clinical trials important in developing treatments for cancer patients?
This is how we figure what works best. Basically, a common form of a clinical trial will be taking what is currently considered standard of care and comparing it head to head with a new treatment we think might be better. If the new treatment is indeed better, then it becomes the new standard of care. This is the way—step by step—that we can improve our ability to take care of patients with cancer.
What is the new law and why was it needed?
One of the things that concerns patients is the financial impact of participating in a clinical trial. Until now, some patients have been concerned that maybe their standard costs of medical care—their doctor's visits, their blood tests, their X-rays—would no longer be covered by their insurance company if they agreed to participate in a clinical trial.
With this new law, that is no longer a concern. They know, based on the law, that their standard costs of medical care will be covered. So it's one less impediment to their participation in the study.
We never put a patient on a clinical trial unless they've given us both verbal and written informed consent that they want to participate.
Currently how many patients participate in a clinical trial at the Holden Cancer Center and how many trials are there?
We currently have more than 200 different trials open in our cancer center. Some of these are being done only here; some are being done with national groups. We can divide these into two basic groups.
- The most common group in clinical trials is what we call therapeutic trials. We put about 300 patients per year on therapeutic trials that are testing new treatments.
- We probably put three or four hundred more patients on what we call registry trials. These are trials where patients provide a blood sample or a tissue sample that allows us to look at the biology of cancer and how it behaves. It's not testing a new treatment, but it allows us to follow-up closely to see how new treatments are working.
Overall, I would say each year we enroll about 700 patients on clinical trials of all types.
How do you expect the new law to affect participation in cancer clinical trials at the Holden Cancer Center?
We hope it results in more participation by removing the financial concern from those patients who have decided they would like to participate in such a trial.
Is every patient with a cancer diagnosis offered the chance to participate in a clinical trial at some level?
Not every patient, in part because these trials are ruled or governed by very strict rules. For example, if we have a new treatment that could have potential side effects related to the heart, we wouldn't want to enroll someone who has heart disease onto that trial. We're unable to offer every patient with a cancer diagnosis participation in a trial, but many patients are offered the chance and it's up to the patient to decide whether this is something they're interested in or not.
Are there other states that currently have a similar law?
There are. There are now about half a dozen states that have similar laws. Each one is a little bit different, but this is something that is moving across the country and it's something that's part of the discussion of health care reform in Washington, as well. So it's possible there'll be a federal law in addition to state laws.
Nationally, is there an existing law at the federal level that is similar to the law in Iowa and other states?
There is not, and that's part of the reason we felt that it was important to pass this in Iowa, even though it's being discussed in Washington. Plus, just due to the complexities of regulation that the state law doesn't cover insurance companies that are regulated at the federal level. So we think it's very important for this to take place at the federal level and the state level. |