For someone facing a diagnosis of malignant mesothelioma, cancer clinical trials often present the best chance for improving their prognosis and living a longer, more comfortable life. This is especially true now, as researchers and doctors around the world are making fundamental discoveries about the role that genetics plays in both the development of cancer and the possibility of developing effective, targeted and individualized treatments for mesothelioma and other cancers. There are currently dozens of clinical trials exploring new options for treating cancer, including all forms of mesothelioma, but not all clinical trials are appropriate for every cancer patient. Understanding how cancer clinical trials work, how patients are selected for them, and how to learn more about them can help patients and their families evaluate their treatment options and decide on the best course of treatment for them.
Cancer Clinical Trials 101
The U.S. Food and Drug Administration requires that all new drugs, treatments and diagnostic methods undergo a schedule of testing before they will grant approval and release it to the general public. The clinical trials help detail how effective the treatment is, what side effects patients may encounter, and the best methodology for implementing the treatment. They are a vital tool in developing and releasing new drugs, treatments and diagnostic methods for cancer and other diseases and conditions.
New drugs and treatments generally go through three phases of clinical trials, each expanding the number of human patients participating. In general, by the time a new treatment reaches the clinical trial phase, it has already been in development for an average of six years. Those six years will include studies, animal research and other types of research to determine whether the drug or treatment is likely to be useful in treating humans. Once the pre-clinical phase is complete, according to the American Cancer Society (ACS), it takes an average of eight years between the beginning of clinical trials and final approval. Each step of the way, the researchers and developers must follow specific protocols to ensure that their data and findings are correct and useful for human patients.
Understanding Clinical Trial Phases
Each phase of a clinical trial is designed to answer specific questions about the new treatment, and carries different benefits and risks to people who agree to take part in them. Knowing the phase of the clinical trials being considered can help patients decide whether they want to participate in them.
Phase 0 Cancer Clinical Trials – How Does It Work?
Phase 0 trials are not a required part of all testing, and there are few openings for volunteers to participate. These earliest stages of testing are designed to find out if an how a new drug or treatment works in human patients. They are usually very short term, and only involve a few participants. The ACS notes that participants in Phase 0 trial are unlikely to benefit personally from their participation. The information learned in this phase, however, can eventually benefit others. At the same time, the risks of participating in a Phase 0 study are minimal, since the dosages are generally very low, and the duration of treatment is short.
Phase 1 Cancer Clinical Trials – Is It Safe?
The focus of Phase 1 clinical trials is the safety of the treatment. It is the first phase of the studies that involves a significant number of patients, and the researchers focus on possible side effects and dangers, as well as attempting to determine the highest and most effective dosages of new drugs and/or proposed treatments. Phase 1 studies are usually carried out at major medical centers, which may limit the possibility of participation. In addition, this early phase carries the largest potential risk for participants, and is not designed to test how effective a new treatment is against cancer. They usually only involve a few dozen participants, and are generally open to people diagnosed with many different types of cancer.
Phase 2 Cancer Clinical Trials – How Well Does It Work?
In Phase 2 trials, researchers are looking for evidence that the new treatment or drug actually works against specific cancers using specific measures. They may be looking for reduction or elimination of tumors and other evidence that the protocol being tested actually has a benefit in fighting cancer. They usually involve 100 or so volunteer participants, and are most often carried out at major medical centers and cancer treatment centers, but may also be carried out in doctors offices and community hospitals. Researchers also continue looking for side effects, since the larger number of participants increases the possibility that they will find specific interactions that may not have been evident in smaller groups. Participants may receive the actual treatment, or a placebo.
Phase 3 Cancer Clinical Trials – Is It Better than Existing Cancer Treatments?
Phase 3 clinical trials are designed to measure the effectiveness of the proposed treatment, and compare it to current standard treatments for cancer. They generally include several hundred participants, and are carried out in settings across the country and around the world. While participants in Phase 3 trials may receive a placebo, if there is a current standard treatment for their type of cancer, the placebo will be given along with the standard treatment. This increases the chance that participants will benefit from the new treatment. Phase 3 trials are safer than the earlier stages because researchers already know how to limit and eliminate those who are most likely to have adverse reactions to the new treatment.
Phase 4 Cancer Trials – What Else Can We Learn?
The safest of the phases, Phase 4 clinical trials are designed to answer important questions beyond safety and effectiveness of a new treatment. They happen after a new drug has been approved by the FDA, and generally involve thousands of patients in hundreds of settings. The risks of participation are low, since earlier stages have established the safety of the treatment, the most effective dosages and durations, and potential interactions that may height risk or improve the effectiveness of the treatment.
What to Consider
When deciding whether a particular clinical trial is right for you, it’s important to consider a number of factors, including these:
- Is it appropriate for the type of cancer you have?
- Is it being held at a location near you, or to which you can travel?
- Are the risks ones that you are willing to accept?
- Do the possible benefits outweigh the risks?
- What does your oncologist think?
- How will the proposed treatment affect your family?
Cancer clinical trials are especially important for those diagnosed with one of the forms of mesothelioma because so few effective treatment options exist. The current clinical trials, and ones that will open in the foreseeable future, include treatments as well as new diagnostic methods that could identify mesothelioma at earlier stages, opening the door to using more effective drugs and conventional therapies against this deadly form of cancer.