(Note: Part Three of our series on Mesothelioma Clinical Trials)
Mesothelioma clinical trials are medical research studies used to test new mesothelioma treatments to see how they affect people. Clinical trial proceed in several stages. What follows is a brief overview of Phase III and IV trials.
Phase III clinical trials for mesothelioma compare the safety and effectiveness of the new treatment against the current standard treatment. Drug treatments that have been proven relatively safe in phase I and that work against mesothelioma in phase II studies can advance to the third stage of testing.
Phase III clinical trials typically enroll a large number of patients, at least several hundred. These studies are often done in many different locations at the same time. Phase III studies are often randomized and double-blinded. What that means is that patients are chosen at random to get either the standard treatment or the new treatment and neither the patient nor the doctor knows which treatment the patient is getting. Placebos are sometimes used in phase III studies but not alone if there is already a treatment available that works.
Phase IV Clinical Trials for Mesothelioma
Phase IV studies are a comprehensive Food and Drug Administration (FDA) review. The treatment is delivered along with a new drug application for approval. The FDA will review the results from the studies conducted in the first four phases and ask questions, order more tests, or simply approve the new drug. The approval of the new drug can be stalled by up to five additional years if more tests are required.
But if the FDA approves the drug in this phase, it becomes the new standard of care which all newer drugs must test against before being approved for use.
For more information on mesothelioma clinical trials and their phases, visit the American Cancer Society.
If you would like to take part in a mesothelioma clinical trial, start by asking your doctor if your clinic or hospital conducts any. ACS has a clinical trials matching service available online. You can also get a list of current clinical trials by visiting the National Cancer Institute’s clinical trials Web site at www.cancer.gov/clinicaltrials.
Contact Sokolove Law about filing a mesothelioma lawsuit that may result in a mesothelioma settlement that could help you and your family get in-home medical care and pay off medical bills, debts, and other expenses.