This article is the part of a monthly series of stories focused on cancer issues. Denver7 is proud to partner with the American Cancer Society, Cancer Support Community, Colorado Cancer Coalition and Sarah Cannon Cancer Institute at HealthONE to bring you these stories, tips and resources.
DENVER -- Cancer research plays an important role in making new advances in prevention, early detection, treatment and care for those with cancer.
The American Cancer Society cancer research program began in 1946 and since then has helped more than 24,000 investigators make important discoveries, with 47 Society funded researchers also receiving the Nobel Prize. Some of the advances the American Cancer Society has supported include:
- Furthering knowledge of the genes linked to breast cancer
- Pioneering work in bone marrow transplants
- Finding a key driver of the blood cancer chronic myeloid leukemia
- Proving that obesity increases the risk of premature death, and establishing the link between obesity and death from certain types of cancer
In Colorado, the American Cancer Society is currently funding 17 multi-year research grants totaling $9.2 million.
What are clinical trials?
Clinical trials, also known as medical research studies, are carefully designed tests of medicines and treatment options under the supervision of a physician. These studies rely on people, called study participants, to try the new medicine or treatment that may have fewer side effects, or provide an effective treatment that is better than the one currently in use.
"Without clinical trials, we wouldn't know how to treat patients with cancer,” said Gerald Falchook, MD, MS, Director of Drug Development at Sarah Cannon Research Institute at HealthONE. “If we had perfect treatments for cancer, we wouldn't need clinical trials. But we don't have perfect treatments for most cancers, and there is always room for improvement on the treatments that we do have. So every clinical trial is an opportunity to find a new and better treatment."
While many clinical trials involve new drugs that haven't yet received approval, others focus on changes in how certain therapies are done or drugs are administered. Clinical trials are also conducted on drugs that have already received FDA approval for one indication (i.e., one type of disease) but look promising for other indications.
Who oversees clinical trials?
Clinical trials must follow strict rules set by the Food and Drug Administration (FDA), and each trial must be approved by an Institutional Review Board (IRB) group of both medical and non-medical community members responsible for protecting the study participants and making sure that the study complies with the law.
Why should I enroll in a clinical trial?
Being in a clinical trial gives you the opportunity to receive therapy that may be more effective or better tolerated than therapies that are currently on the market. Another benefit to enrolling in a clinical trial is that it gives you the opportunity to help future generations with the same disease. Every treatment and drug that is currently used had its beginnings with clinical trials, with patients who were willing to help science find new and better ways to treat disease.
Can I leave the trial any time I want to?
You can withdraw at any time. All you need to do is notify your physician you no longer wish to continue.
First-in-man, Phase I, Phase II, what do all those terms mean?
Clinical trials involve several phases. These include:
- Phase I: testing the safety of the drug in humans
- Phase II: testing the effectiveness of the drug, including dosage and timing of treatments
- Phase III: comparing the new treatment to the one currently in use
- Phase IV: following the drug after it is licensed and approved by the FDA, to track its safety and gain more information about its risks, benefits and optimal use
First-in-man means that it is the first time the drug has been tested in humans and that, up to this point, the drug has only undergone pre-clinical and animal testing.
What else should I know about clinical trials?
Before you enroll in a study, you will receive an Informed Consent Form that provides the following information:
- A detailed description of the study
- Any possible risks and benefits of participating
- Information about any financial obligations you may incur by participating
Your physician and research staff will make sure you are completely educated before the trial begins and answer any questions you may have before and during the trial.
How can I find out if I'm a candidate for a clinical trial?
For more information about clinical trials, contact your physician or the “Ask Sarah” information service at HealthOne’s Sarah Cannon Research Institute by calling 1-877-691-7274 or emailing firstname.lastname@example.org.
What Are the Goals of Cancer Clinical Trials?
Today's clinical trials are tomorrow's latest treatment option. Every therapy, drug or approach that is in place today to treat cancer had its start in a clinical trial.
This process takes time, beginning with laboratory research followed by studies with animals before the drug or therapy moves into the clinical trial phase, a process that on average can take approximately seven years.
"The decision to move a drug from the lab to people in a clinical trial is a big decision, a complicated one, and a very expensive one, too,” said Dr. Falchook. “In order for a drug to move forward into a clinical trial, it needs to look very promising in the lab, as well as demonstrate safety in animal studies. It needs to be clear how the drug is given, whether it's a pill or IV, and how it's absorbed. All of these things are studied extensively in animals before a drug enters a clinical trial."
But while most cancer patients have to wait until FDA approval is gained, those patients participating in a clinical trial have the opportunity to get early access to new treatments.
"Some patients have already undergone standard treatment for the cancer that didn't work. Clinical trials provide new options for those patients," Dr. Falchook noted.
Clinical Trial Successes
At Sarah Cannon Research Institute at HealthONE, where the focus is almost exclusively on Phase I clinical trials, the level of patient interest in participating in trials has been overwhelming.
"We are far ahead of the initial expectations, in terms of enrolling patients," said Dr. Falchook, "There are more patients requesting to be enrolled on trials than we have spots available. It's an exciting time in cancer research, with progress in the lab leading to a pipeline of new drugs entering trials in the clinic. We've seen lots of wonderful successes, including many new drug approvals by the FDA of targeted drugs and immunotherapy drugs in the last few years, for many types of cancer."
At a personal level, Dr. Falchook finds his work immensely rewarding.
"When you are treating cancer patients, you want to do everything you can to help them. And when there are no good treatments or options for these patients, it takes research to find something that will be effective,” Falchook added. “In the past few years I have performed three first-in-human trials that were so successful that these treatments later received FDA approval. That was extremely satisfying to me to know that the patients who participated had so much benefit and that now these treatments are available all over the world to help thousands of other patients. That's what really draws me to this kind of work: finding better treatments for patients living with cancer."