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.
As Gerald Falchook, MD, MS, Director of Drug Development at Sarah Cannon Research Institute at HealthONE put it, "Without clinical trials, we wouldn't know how to treat patients with cancer. 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.
From Lab to Treatment
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, said Dr. Falchook. "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. 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. For example, 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.”