(This is the third and final part of our series on Mesothelioma Clinical Trials.)
Phase III clinical trials typically enroll a large number of patients. These studies are often done in many different locations at the same time. They are likely to be offered by community-based oncologists.
Typically, drug treatments that have been proven relatively safe in phase I and that have been found to work against mesothelioma in phase II studies can advance this stage of testing. Phase III clinical trials for mesothelioma compare the safety and effectiveness of the new treatment against the current standard treatment.
Phase III studies are often double-blinded as well as randomized. 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 may be used in some phase III studies, but they are never used alone if there is already a treatment available that works.
Phase IV Clinical Trials for Mesothelioma
Phase IV studies are not additional tests conducted by the researchers, but rather a comprehensive Food and Drug Administration (FDA) review. The treatment is delivered along with a new drug application (NDA) to the FDA 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. If more tests are ordered, the approval of the new drug can be stalled by up to five additional years. If, on the other hand, 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.
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.
For more information on mesothelioma clinical trials and their phases, visit the American Cancer Society.
Filing a mesothelioma lawsuit may result in a mesothelioma settlement, which could help pay for in-home medical care and pay off other bills, debts, and other expenses. Contact Sokolove Law today to learn more about pursuing your legal options.