5 Things to Know Before Starting a Mesothelioma Clinical Trial
March 17, 2020
Enrolling in a clinical trial for mesothelioma can be an exciting and frightening experience. You will be giving yourself a chance to receive the best treatment available and helping future patients on the same journey as you.
Participating in a clinical trial is not the same as a standard visit with your physician, however. Knowing what to expect ahead of time can prepare you for the unexpected during the course of a clinical trial.
Review Eligibility Requirements
Many patients believe their physician grants them access to a clinical trial by chance or preference. In reality, your medical history and previous treatments determine your qualification as a candidate.
Every clinical research trial has an extensive list of inclusion and exclusion criteria. In order for a patient to be eligible, they must meet every requirement in both categories. If you are considering enrolling in a trial, ask your physician or their research staff for a copy of the eligibility requirements.
Ask questions about any requirements you’re unsure about and have your medical records available.
Items to Include in Your Medical Records
- Surgical history
- Medical history
- Previous cancer diagnoses
- Medication list
Ensure your medication list is updated, so your physician can determine whether you are taking anything prohibited during the trial.
Prepare for the Screening Process
Once you have thoroughly discussed the clinical trial with your medical team and family members, and you meet all inclusion and exclusion criteria, you will be asked to sign an informed consent.
The document can be lengthy. Typically, you are given a copy of the consent form to review in advance, so you can ask questions.
Questions to Ask Your Research Team Before Signing Consent
- What are the costs?
- What are the risks of participating?
- What type of long-term follow-up care can I expect?
- What are the odds I receive a placebo in this trial?
The research team and your physician will lead you through the consent and then enroll you into the next step, which is the screening process.
Before you have the opportunity to receive the experimental medication, there will be a preliminary series of blood tests and imaging scans. These tests will guarantee the clinical trial does not put you at an increased risk for permanent damage.
The screening period usually lasts two to four weeks after signing consent, during which time you will be asked to return to your treatment center for blood work and imaging such as CT or MRI exams.
Because you have been enrolled into the trial at this point, any tests or exams that are not considered conventional treatment (tests your doctor would normally prescribe) are likely covered by the research trial.
Understanding Randomization in Clinical Trials
Once you have completed all the screening activities, you will be randomized to a treatment arm. If you are deemed high risk or ineligible for the trial during the screening period, your physician will discuss alternate conventional treatments with you.
For most trials, randomization means being assigned a treatment that either includes or does not include the experimental drug alongside the conventional therapies.
Your physician and research team can provide you details on how many treatment arms there are for your study and the chances of being randomized to each one.
Plan for Extra Visits and Tests
Although you will have likely experienced increased travel and doctor visits during screening, you should be prepared to maintain that frequency during the early stages of the trial.
Your physician and research team will provide you a schedule of activities that details exactly how many visits will be expected and what will be performed at each visit.
This schedule will unlikely change during the course of your study, but if it does, your medical team will inform you in advance and ask that you sign an updated consent form.
You should also be prepared for any unexpected visits. Participating in a clinical trial involves several unknown risks, and any changes in your health status can prompt your physician to schedule an unplanned visit.
Before enrolling in a trial, ensure you have adequate transportation and discuss any possible reimbursement with your research team. Because clinical research is testing the latest medicine, your doctor will track you closely during the first several months of the trial.
Review Your Progress
During your experience in a clinical research trial, you may wonder how your cancer is reacting to the experimental medication. While data regarding the overall clinical trial may be unavailable, your physician will review your progress in a number of ways:
- Tumor size measured by imaging scans
- Performance status based on your level of daily activity
- Overall health after a physical exam
- Organ function tracked through blood work
Keeping up with your progress during a clinical trial can help you make informed decisions about whether to continue with the research trial or pursue another treatment.
Expect a Long Follow-Up
If you have found success with a clinical research trial that has managed your cancer over a long period of time, you may be wondering how and when the trial will end.
The follow-up period of a trial will vary depending on the protocol and structure of the study. If the study is testing a second-line therapy, your physician may continue you on the experimental medication indefinitely until you experience progression of disease.
If the study is testing an additive medication that is used alongside standard of care in first-line therapy, you may only complete a set number of cycles of chemotherapy or radiation followed by a reevaluation period.
Follow-up activities typically mirror the tests and exams you completed during screening. This information helps the study team collect data on your overall health and benefit after completing the treatment. You will then enter the final phase of the study, which is called long-term or survival follow-up.
During long-term follow-up, someone from the research team will likely call you every few months to determine the status of your cancer and whether you need to pursue other treatment.
Enrolling in a clinical research trial can be frightening, especially when there are many unknowns.
However, with the right knowledge and preparation, you can find the right clinical research trial for you. Partaking in a trial is an exciting experience as you seek new therapies for yourself and help scientists pursue new cancer treatments that lead to inspiring participant stories.