Mesothelioma clinical trials are studies of new treatments for this deadly cancer. These studies need mesothelioma patients to help researchers discover advancements in areas that include diagnosis, pain management, and treatment. If you are interested, you can find lists of mesothelioma clinical trials at the website of the National Institutes of Health, the Food and Drug Administration, and the National Cancer Institute.
The people who run mesothelioma clinical trials have a specialized vocabulary for talking about this vital research. If you’re not a scientist, some of it may sound like a foreign language to you. Here’s a glossary of terms that will help you understand mesothelioma clinical trials.
Mesothelioma Clinical Trials Glossary
Adverse Event: This is a fancy way of saying that something has gone very wrong. It could be an unpleasant side effect of the drug being tested or your health taking a turn for the worse for other reasons. “Serious” adverse events are life-threatening complications. “Other” adverse events are more minor negative outcomes in a clinical trial like headaches, rashes, severe stomach pain, nausea, vomiting, minor swelling, fatigue, drowsiness, speech disorder, and oral dryness.
Baseline Characteristics: The baseline in mesothelioma clinical trials is like the baseline in baseball: it’s the starting point. At the beginning of a study, researchers collect data from all the participants about things like age, health status, and prior treatments. This helps evaluate the change that happens during the mesothelioma clinical trial.
Control or Control Group or Controlled Trial: The control group in a mesothelioma clinical trial does not receive the experimental treatment. The control might receive a placebo (defined below) or the standard treatment. The control allows researchers to compare the new treatment to existing therapies or to no treatment at all. A controlled trial is one that includes a control group. Not all trials use a control.
Eligibility Criteria: If you want to participate in a mesothelioma clinical trial, you will need to meet the eligibility criteria. These are also called inclusion and exclusion criteria. The eligibility criteria for a study could include your age (within a certain range), the type of mesothelioma cancer you have, the stage of cancer you have, or which mesothelioma treatments you already completed.
Enrollment: The target number of participants for a study to be complete. Mesothelioma clinical trials will have different enrollment goals depending on whether they are initial trials (phase one) or advance trials (phase three or four). Once you are signed on to participate in a clinical trial, you are considered enrolled in the study.
Expanded Access: If a new treatment shows promise in mesothelioma clinical trials, the manufacturer can use the FDA’s expanded access process to provide more people with the drug. For patients with serious diseases such as mesothelioma, expanded access could allow you to take an experimental drug that has not yet been put on the market, even if you aren’t able to be part of the clinical trial.
Informed consent: If you choose to participate in a mesothelioma clinical trial, the investigators will want your informed consent. This means that you have been told about all aspects of the study, including possible side effects and adverse events, and you still choose to go ahead. As part of your enrollment process, you will be asked to sign a consent form. Informed consent doesn’t stop after you sign the form, however. You have the right to ask the researchers questions at any time. You also have the right to leave the study at any time.
Intervention: This is the clinical trial term for the new treatment that is being studied. The control is the old treatment (or no treatment) and the intervention is the new treatment.
Investigational New Drug: Drugs that are the subject of mesothelioma clinical trials but haven’t yet been approved by the FDA are investigational. They will be unavailable or not widely available, except to participants in the clinical trials.
Investigator: The researchers who design and run clinical trials are called investigators. The principal investigator or study principal investigator is the person who oversees the clinical trial. Investigators in mesothelioma clinical trials are often medical doctors and are usually connected with the world’s best medical centers.
Masking (also called Blinding): This refers to the withholding of some information from mesothelioma clinical trial participants and sometimes even the investigators. In a single blind study, you won’t be told whether you are in the test group for the new treatment or in a control group with a different treatment. Researchers do this to make sure that you accurately report the effects of the drug. If you knew which group you were in, this might affect your perceptions about the treatment. A double blind study keeps both investigators and participants in the dark. This prevents researchers from unconsciously changing their observations based on what they expect to see.
NCT Number: When the government funds mesothelioma clinical trials, they are given NCT numbers. This is an ID number. If you know the NCT number for a study, you can search for it by that number.
Phase: Mesothelioma clinical trials are broken down into phases. At the end of each phase, the trial can stop or advance, depending on the results. The initial phase will involve very few participants; more people will be asked to enroll in later phases of the trial, after investigators have confirmed the best dosage and delivery method for the treatment.
Placebo: A substance that looks like the intervention but has no medically active properties. Placebos are sometimes called sugar pills (because they sometimes are sugar pills). Study participants given placebos sometimes have positive health outcomes because of the placebo effect: if your brain thinks you should be getting better, you might just get better.
Protocol: The design of a mesothelioma clinical trial is called the protocol. This is a written description outlining the purpose of the study, how many participants it will have, whether a control will be used, and the intervention that will be studied, among other things. You can ask an investigator to explain the trial’s protocol to you as part of your informed consent.
Randomization or Randomized Allocation: When participants are randomly assigned to the control or intervention group in mesothelioma clinical trials, this is called randomization or randomized allocation.
Recruitment Status: Recruitment status tells you whether or not mesothelioma clinical trials are adding new participants. Open studies are either recruiting (actively accepting participants), not yet recruiting (no one has been enrolled yet, so be patient), or available for expanded access (the study is underway, but you can still join). Closed studies are no longer enrolling participants. They may be active but have as many people as they need or they might be completed.