How Do Clinical Trials Work?
At some point in your life you probably heard the words “clinical trial”, but you may not know how they work, who they are for or what they are trying to accomplish. Mesothelioma clinical trials and treatment opportunities are available for eligible candidates.
A clinical trial is any study that recruits human participants to help understand if a new medical therapy, drug or device is safe and effective for general public use.
Researchers use clinical trials to find new and better ways to prevent, treat or manage cancer and other diseases. Due to the limited treatment options for mesothelioma, clinical trials can give patients a critical treatment alternative. Trials have the potential to extend the lives of mesothelioma patients. As with all treatments, it’s important to understand both the benefits and the risks.
Stages of a Clinical Trial
Before a drug or therapy is tested in a clinical trial, it’s investigated in pre-clinical studies. These studies are conducted on cells, tissues or animals. If the pre-clinical results are promising, the drug or therapy moves into a phase 1 clinical trial.
Clinical trials are organized into stages, depending on the extent the drug or treatment has been investigated and the goal of the study. Each stage of a clinical trial helps researchers answer specific questions.
Clinical trials in phase 1 investigate treatments for the first time. These trials test the new drug or therapy on small groups of people, with the main purpose of assessing if the treatment is safe.
Researchers in phase 1 clinical trials look for a safe dosage range and identify any side effects.
Clinical trials in phase 2 offer treatments to larger study groups—usually over 100 people. Trials in this phase gather initial observations on the effectiveness of the drug or therapy.
Researchers in phase 2 clinical trials confirm a safe dosage range and watch for any additional side effects or safety concerns.
Clinical trials that move into phase 3 are opened up to even larger study populations—usually 1,000 people or more. Trials in this phase compare the treatment in question to commonly used treatments to assess the new treatment’s effectiveness.
Researchers continue to monitor side effects and collect key information that will allow the new treatment to be safely used by the general public.
Phase 4 clinical trials are conducted after a drug has been approved and released to the public.
Researchers in these types of clinical trials are looking for the best way to use the drug and monitor the benefits and risks of long-term use.
Types of Clinical Trials
It may surprise you to know that clinical trials test medical interventions for a wide variety of reasons—not just treatments to extend life or cure disease.
Clinical trials are organized into 5 different types, depending on what the researchers are testing for.
- Screening: These trials help doctors find more accurate, faster ways to find diseases in patients sooner.
- Diagnostic: The focus is on finding more effective and accurate ways of diagnosing a certain type of disease.
- Prevention: Researchers attempt to identify lifestyle changes, vitamins, vaccines or drugs that may prevent the development of diseases.
- Treatment: These trials attempt to find new surgical procedures, drugs or therapies to better treat diseases.
- Quality of Life: Researchers in these trials focus on finding ways to reduce discomfort in incurable illnesses.
Who Participates in Clinical Trials?
To test the safety and effectiveness of a new drug or therapy for people, researchers need to recruit volunteers to participate in the clinical trial.
Some trials offer payment with phase 1 trials offering the highest compensation as a reward for the highest risk. Clinical trial participants may be patients with a specific disease or illness. Participants can also be healthy individuals who want to support innovative medical advancements.
Clinical trials investigating new mesothelioma drugs or therapies recruit individuals with a mesothelioma diagnosis. Mesothelioma clinical trials are very specific, with each trial investigating a different disease location (pleural, peritoneal or pericardial), cell type and possibly disease stage.
Patients who are interested in participating in mesothelioma clinical trials will need to review the entry requirements to see if they qualify.
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Steps in Finding and Enrolling in Mesothelioma Clinical Trials
Once you have decided you are interested in participating in a clinical trial, you will need to work with your mesothelioma specialist or doctor to choose the trial that is right for you. There are important steps to take prior to being accepted into a clinical trial to ensure your health and safety.
1. Get a Referral From Your Mesothelioma Specialist
If you have made the decision to participate in a clinical trial, the first step is to speak with your mesothelioma specialist or doctor. Your health care provider will be able to share the potential benefits and risks if you decide to participate in experimental therapy.
Your mesothelioma specialist or doctor may know of a trial that is accepting participants or an upcoming trial that you may be a good candidate for.
2. Learn More About Your Clinical Trial Online
You can find information on all active clinical trials online at www.clinicaltrials.gov. When you receive a referral from your doctor, they can provide you with a study ID number.
Online you can learn details about the trail, including credentials of the research team, the study sponsor and eligibility criteria.
3. Apply and Enroll
If you are still interested in participating in the clinical trial after your web research, you can contact the study organizers via email or phone.
If you meet the eligibility criteria, the organizers may set up an interview or a physical exam to ensure you meet the study standards. You will receive a consent form that will cover the details of your participation in the study.
On your consent form, there will be details on:
- How the study will be organized
- Any specific requirements
- Potential benefits and risks
- How long the study will last
- Contact information for key organizers or researchers
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About Undergoing Trial Testing
After you have been accepted and enrolled in a clinical trial there are a few steps before you being the testing. This starts by arriving at the correct clinical trial location, undergo initial screening tests and then starting with the first dose or trial test. During the trial, you will be regularly monitored for side effects and outcomes and you can quit the study at any point.
Choosing Clinical Trial Locations
In most cases, clinical trials are run by researchers in hospitals, universities or health clinics. If you are traveling to participate in the study, you may have a choice of several locations.
Most clinical trials are multi-center trials and have dozens of locations. Some locations may be more convenient if you have friends or family members who live in the area and can provide you with accommodation. In some cases, hospitals or sponsors may provide financial support for travel or accommodation associated with trial participation.
Initial Tests and First Doses
Once you arrive at your trial location, you will undergo initial tests to establish a baseline before you receive your first treatment. Depending on the type of trial, information may be collected on your complete medical history, along with blood and imaging tests.
If you are participating in a clinical trial that is investigating a new treatment, you will receive your first dose after the initial tests are complete.
If you are in a treatment clinical trial, researchers will monitor your response through ongoing tests. As you receive additional doses, researchers will observe if the treatment is effective in treating your disease. You will continue to receive the treatment and undergo monitoring until the study concludes or you decide to leave.
Reporting Side Effects
Reporting any side effects—regardless of the severity—is very important if you are participating in treatment clinical trial. Researchers may be able to alter treatment delivery or dosage to reduce any negative side effects.
Given that the treatment being investigated is exploratory, researchers need to be aware of all the possible negative side effects, as each user will respond differently.
Quitting the Study
It is important to remember that you have the right to leave a clinical trial at any time for any reason. Your health care provider will continue to provide you with the best possible treatment available.
While participating in a clinical trial, you may want to quit the study if:
- The treatment is not working
- You experience serious side effects from the treatment
- You are traveling to participate in the study and are experiencing financial constraints
Accessing Specialized Mesothelioma Treatment
Mesothelioma clinical trials can provide critical breakthroughs in new ways to prevent, detect or treat mesothelioma. Given the limited treatment options for mesothelioma patients, clinical trials investigating new treatments or therapies have the potential to extend or save lives.
It’s a personal decision to participate in a clinical trial and you should be informed of the potential risks and benefits before you make a decision.
If you have weighed the pros and cons and want to learn more about mesothelioma clinical trials, contact the Mesothelioma Justice Network. The Mesothelioma Justice Network can put you in touch with a mesothelioma specialist. These specialists often run mesothelioma treatment programs at cancer centers across the country.
If you are interested in joining a clinical trial, specialists have the best connections to mesothelioma clinical trial opportunities. Speak with someone from the Mesothelioma Justice Network today and start working with a mesothelioma specialist to ensure you have access to a wide range of treatment options.