Recent medical breakthroughs have led to a host of new cancer drugs coming to market. Many of these offer hope for patients with cancers that are rare or hard to treat, such as mesothelioma. As a result, there are many more cancer clinical trials underway at once than is usually the case. Despite the increasing prevalence of cancer, this research boom has led to a shortage of qualified participants.
Many of the current cancer clinical trials test the effectiveness of immunotherapy drugs and other experimental cancer treatments. Some cancer patients, including some mesothelioma patients, have reported exciting results from immunotherapy treatment.
Immunotherapy drugs are a piece of a larger trend in cancer treatment: personalized medicine. These new treatments focus on very specific mechanisms, often at the cellular level, to fight cancer. The treatments are wonderfully effective, but they usually work well for only a small subset of patients.
Still, many more cancer clinical trials are needed before researchers understand who will be helped by these treatments. Research will also create a better understanding of what drug combinations and dosages are most effective for mesothelioma patients and others.
What Are Cancer Clinical Trials?
To bring a new drug to market, research must go through several stages. After laboratory research, promising new mesothelioma drugs are tested on humans, in cancer clinical trials.
When research reaches the clinical trial stage, it is broken into at least three phases. At each phase, research may stop if the cancer clinical trial doesn’t show positive results. If the new treatment looks promising, it will progress to the next phase.
Phase 0 is an unusual part of the clinical trial process. This pre-trial phase is used to gather information that will smooth the way for the rest of the clinical trial phases. The FDA doesn’t require a Phase 0 trial and most mesothelioma research doesn’t use it.
In Phase 0, the study will have very few participants, usually no more than a dozen. Participants will receive low doses of the drug being tested for a very limited amount of time. Researchers will run tests to determine how the participants react to the drugs.
There are few risks with Phase 0 trials, because the doses are low and the time frame is short. There are also few benefits for participants, because this phase uses such small amounts of the drug. Phase 0 can help avoid expensive larger trials, if the drug doesn’t work.
Phase I cancer clinical trials are designed to determine the best dose of an experimental drug. If you participate in a Phase I trial, you will be closely monitored by the doctors doing the research. They will be looking for adverse effects and negative side effects.
There is no control group and no placebos are given during Phase I clinical trials. This phase usually involves no more than a few dozen test subjects.
Because little is known about how a new drug or drug combination works on the human body in this initial mesothelioma research phase, these trials carry the most risk for patients. However, because there is currently no cure for mesothelioma, you may decide that the potential benefit of being the first to receive a new treatment is worth the risk.
Once researchers have established safe doses in a Phase I trial, they will progress to Phase II. At this point, the study can include anywhere from a couple of dozen participants to more than 100. The Phase II trial tracks the effectiveness of the new treatment and can last for a period of months up to a couple of years.
Many Phase II trials include randomly selected control groups that receive a standard treatment or no treatment at all. Because of the serious nature of mesothelioma and other rare cancers, some cancer clinical trials are not “blind” tests like this and provide all participants with the same treatment.
Phase III is the final set of trials before a new drug comes to market. These trials have traditionally included hundreds or even thousands of participants. Phase III trials allow researchers to develop a better understanding of the effectiveness of the treatment and provide further proof that it works across a large population.
Because of the small number of patients who meet the criteria for narrowly-targeted new gene therapy or immunotherapy treatments, it has been difficult or impossible for researchers to find enough participants to conduct large Phase III cancer clinical trials. Scientists and regulators have had to make do with smaller groups of test subjects, according to recent reporting by the New York Times.
Wave of New Cancer Clinical Trials
Another reason for the shortage of participants is the large number of active cancer clinical trials at the moment. This is partly due to the fact that different drug companies want to bring their own version of successful immunotherapy treatments to the market.
That’s not the whole story, though. Data about the ways that cancer cells hide from your immune system has created many possibilities for immunotherapy treatments. Sophisticated lab testing has opened the possibility of a mesothelioma treatment tailored to the cancer cells in our specific tumor.
All this means new hope and new treatment options for mesothelioma patients. It also means a glut of cancer clinical trials. This has sometimes left researchers scrambling for participants.