Many people who have been diagnosed with malignant mesothelioma will want to participate in a clinical trial. For many patients, clinical trials offer hope when other treatments have not worked, or when existing treatments have been ineffective in reducing the size of the mesothelioma tumors or providing relief from mesothelioma symptoms. At the same time, patients frequently want to be involved in clinical trials in order to have access to cutting-edge therapies or to learn about current mesothelioma research that is being undertaken. Many mesothelioma and other asbestos-related cancer patients feel that participation in one or more clinical trials gives them an opportunity to exercise some control over their health care and treatment, and to play an important role in making choices about treatment options. Yet if you do not qualify, what can you do, and what should you know?
Failing to meet the eligibility for a clinical trial can feel devastating, but it is important to remember that you may have other options. First, if you do not qualify for a clinical trial, you should remember that there are also disadvantages to many clinical trials, and patients can experience significant side effects that can be harmful. It is also important to remember that failing to qualify for a specific clinical trial does not necessarily mean that you will not qualify for a clinical trial in the future. You should learn more about eligibility and the criteria for inclusion and exclusion in clinical trials. Then, you should understand how pre-screening and screening for clinical trials works, and what options you may have for alternative treatments if there are no possibilities for participation in a clinical trial.
When You Do Not Qualify for a Clinical Trial, You May Be Avoiding Potential Side Effects
While clinical trials can be beneficial to patients for many different reasons, there are also disadvantages and cons to consider, including the possibility of serious side effects. In the best-case scenario, a clinical trial will provide one or more health benefits to patients that outweigh the harms. Yet in some of the more complicated clinical trial scenarios, a patient will experience significant side effects and an outcome that is not what the patient or their family (or the researchers) had hoped for. Accordingly, it is critical to think carefully about participating in a clinical trial and whether it is the best option for you.
Not Everyone Will Qualify for Clinical Trials
In some circumstances, you may not have the option to participate in a clinical trial. It may be that you want to participate, but you do not meet the criteria, or you are not healthy enough for the researchers to agree to your participation in the study. There are various types of eligibility criteria that people need to meet, and there are often highlighted inclusion and exclusion criteria, according to the American Cancer Society.
For patients struggling with mesothelioma, especially when other treatments have not been effective, it can be devastating to hear about a clinical trial that sounds promising only to learn that you do not qualify for it. It is important to keep in mind that there are a very wide variety of clinical trials, and simply because you do not qualify for one particular clinical trial does not mean that you will not qualify for another clinical trial later on. Moreover, if your health and general well-being are such that you do not qualify, you should know that it may be possible to get to a place where you are healthy enough to be able to take part in a clinical trial. You should speak with your health care provider about potential clinical trial options and how to prepare yourself for eligibility.
Eligibility for a Clinical Trial: Inclusion and Exclusion Criteria
The American Cancer Society explains that eligibility for a clinical trial is based on various eligibility criteria. Within those eligibility criteria, two terms are commonly used: inclusion criteria and exclusion criteria. When researchers refer to inclusion criteria, they are referring to factors that would allow a person to participate in a clinical trial, or to be included in a clinical trial. Exclusion factors refer to factors that would be used to exclude a person from a clinical trial.
Having one or more inclusion criteria does not necessarily mean that a person will be able to participate in a clinical trial, and having one or more exclusion criteria does not necessarily mean that you will not be able to participate in a clinical trial. However, there are certainly many situations in which certain inclusion criteria are required for participation, and in which certain exclusion criteria mean that a person cannot participate in the study. Ultimately, the goal of using inclusion and exclusion criteria to determine eligibility is to ensure that research participants can be safe (or as safe as possible), and that their participation will be able to benefit the study. The American Cancer Society cites the following subject matter for inclusion and exclusion criteria:
- Type of cancer a person has;
- Stage or extent of a person’s cancer;
- Previous cancer treatments the person has had;
- Length of time since the person’s last treatment;
- Lab test results;
- Current medicines the person is taking;
- Other medical conditions the person has;
- Previous history of any other type of cancer;
- Person’s activity level (also known as performance status);
- Person’s age; and/or
- Person’s sex.
Criteria may be modified at different phases of the study, or based on information and data obtained through research. Accordingly, even if you do not qualify for a particular phase of a clinical trial, you could be eligible to participate in a subsequent phase of the clinical trial.
Pre-screening and Screening to Determine Eligibility for a Clinical Trial
There are many different reasons that a person might not qualify for a clinical trial, and those kinds of determinations will be made either during the pre-screening process or during the screening process. These processes are designed to ensure that you meet the inclusion criteria and that you are healthy enough to take part in the study.
Pre-screening will usually occur before a patient is asked to sign the informed consent form in order to participate in the study. A pre-screening session will usually involve a questionnaire, a meeting with one of the researchers involved in the study, and a determination of the patient’s performance status to determine whether that patient is healthy enough to participate in the study. Some pre-screenings may require more invasive procedures such as blood tests or scans like X-rays or MRIs to determine whether the patient is a good fit for the study. It is only once a patient has been pre-screened (and, accordingly, pre-approved in a sense to participate in the study) that the patient can move into the screening process.
In screening, a patient will nearly always be required to undergo medical procedures and lab tests to determine their performance status and their ability to participate safely in the study. While scans or tests can sometimes be used in pre-screening, a mesothelioma patient should almost always expect to undergo scans like MRIs or X-rays during screening, and to have blood tests and any other relevant laboratory work and tests conducted prior to their participation in the study. As such, you could be determined ineligible to participate in a clinical trial following a pre-screening process, or you could go through pre-screening and sign your informed consent form, only to learn that you are ineligible during the screening process based on the outcome of your tests or laboratory work.
Seeking Alternate Options: Experimental Drugs, Alternative Medicine, and Compassionate Use
When you are ineligible to participate in a clinical trial, beyond waiting for other clinical trials in which you could be eligible to participate, you can consider alternative options that may include experimental treatments. In some cases, according to the American Cancer Society, you may meet all of the eligibility criteria for a clinical trial, but the trial may have already enrolled enough participants. In those circumstances, you could be eligible to be among the first patients to receive the treatment being tested in the clinical study if they are ultimately approved by the FDA.
In addition, you could be able to gain access to certain treatments being tested in clinical trials when they are in their later phases (like a Phase III trial) but before they have received FDA approval. To be eligible for this type of access to drugs or treatments being tested, you may have been too ill to participate in the study, but you may have exhausted all other treatment options for your mesothelioma. The American Cancer Society explains that, under these types of circumstances, you could be eligible for what is known as “expanded access” or “compassionate use” programs if you are in urgent need of the treatment being tested.
If you are in this situation, you should speak with a health care provider to determine possible experimental drugs, alternative medicines, or compassionate use program participation. Even if you are too ill to be involved in a clinical trial, these options may be available to you.