In past blogs, we’ve talked about things our community can do to help advance research and improve treatments for patients facing the challenge of colorectal cancer, including asking Senators to pass the 21st Century Cures Act and supporting the Administration’s Moon Shot initiative. But there is a vital element of advancing research that is outside the control of the scientists who conduct the work and the entities that fund it: clinical trials—the link between scientific discovery and new treatments for colorectal cancer.
The Food and Drug Administration (FDA) is responsible for ensuring that any prescription drug sold in the United States is both effective and safe. The agency employs a rigorous, multi-phase process designed to prove that any new drug or biologic will achieve its claimed clinical result and will do so with a minimum of known risks. In the first phase, developers must establish the drug’s safety and determine how much of the drug should be given. The second phase involves proving the drug works in a small group of volunteers and that the level of side-effects is reasonable. Not many new drugs ever get beyond phase two—just one out of every one thousand that enter pre-clinical testing. Only after a new drug successfully passes these two phases is there the opportunity to conduct what your doctor will likely refer to as a “clinical trial.”
In phase three clinical trials, a large number of cancer patients try the new drug at the same time similar patients are on older therapies, sometimes called the standard of care. Comparing the two groups enables the developer and the FDA to determine if the new drug improves the outcome for patients and what level of side-effects patients must deal with to obtain that outcome. Only if the FDA decides that the new drug provides a positive benefit for patients is it approved and available to doctors to prescribe.
Unfortunately, it is the lack of patients willing to participate in phase three clinical trials that slows, and in some cases stops, a new therapy from becoming available. Even for drugs that do get approved, the delays in recruiting enough patients for the clinical trial add significantly to the cost of the drug. Forty percent of clinical trial sites are stopped because they can’t recruit the minimum number of patients; in fact, only 3 percent of patients participate in a clinical trial.
There are many reasons for the lack of participation, such as the inconvenience or cost. But the biggest problem is that many patients have misconceptions about clinical trials. Patients often think of a clinical trial as “experimental” and they are going to be a human guinea pig. These patients regard the trial as an avenue of last resort; after all, existing treatments fail. By that point, they are likely too ill to qualify for the trial.
In reality, there are rigorous standards protecting people who participate in clinical trials. A clinical trial offers participants the opportunity to access a new therapy that could be significantly better than the standard of care years before it is widely available. There is no guarantee that it is better, but keep in mind it has gone through many years of research and testing before it is ready for clinical trials and a company is betting over a billion dollars that it is an improvement over the standard of care. So a clinical trial should not be viewed as “just an experiment.”
Whether or not you or a family member is considering a clinical trial, anyone interested in what is on the horizon for new treatments for colorectal cancer should know about trials being conducted. The Colon Cancer Alliance is your best resource for the information through Data Blue, an innovative portal that allows you to search colorectal cancer trials by geography, stage at diagnosis and other factors. Additionally, Data Blue provides important information you need to know if you are considering a clinical trial.
Please check out Data Blue and let us know what you think about it. As always, Speak Up and Speak Out.
Speak Up, Speak Out is an advocacy series where we bring you the information you need to know every third Tuesday of the month. Don’t forget, the Colon Cancer Alliance serves as a source of information about colon health. If you have questions or are in need of support, please contact our free Helpline at (877) 422-2030.