This page was written by experienced mesothelioma nurses, Eleanor B. Ericson, RN, BSN and Lisa Hyde-Barrett, RN, who have decades of experience working with mesothelioma patients and their families. Patients and families affected by mesothelioma who contact MesoLawyersCare can be now be put in contact with Ellie and Lisa to address their medical questions and needs.
Clinical Trials for Mesothelioma
Advancements in the treatment of mesothelioma, and hopefully a cure for this cancer, will only occur through research. Clinical trials is one form of research for mesothelioma and other diseases that is used by the medical community. Clinical trials provide the structure and transparency necessary for research into mesothelioma. An important part of the clinical trial process mandates that the findings can be duplicated by others, using the same methods. The results of clinical trials supply evidence as to whether a particular treatment or protocol works on a certain group of patients.
Mesothelioma Clinical Trial Digest
The Mesothelioma Clinical Trial Digest (“Meso Digest”) is the only published guide to all active clinical trials for mesothelioma. The Meso Digest is authored and updated 4 times a year by medical professionals who have decades of experience in the treatment and care of mesothelioma patients.
MesoLawyersCare is proud to make the Meso Digest available for free both as an electronic book (“eBook”) or as a convenient paperback.
What are Clinical Trials?
The definition of clinical trial by the National Institute of Health is:
“A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health- related biomedical or behavioral outcomes.”
There are different types of clinical trials. In cancer research, there are treatment trials with interventions that are being analyzed, some are observational (studying health issues in a specific population of people), some are focused on prevention, and some focus on screening and quality of life, supportive care.
Clinical trials can be held in a variety of settings and many involve more than one medical center. Because the population of mesothelioma is small relative to other cancers, many clinical trials are held with co-operating mesothelioma academic centers. Every hospital has an Institutional Review Board (“IRB”) whose function is to review and approve all research in order to protect the safety of participants.
Mesothelioma Clinical Trial Information
Phases of Clinical Trials
There are distinct phases of clinical trials, time lines and protocols to be followed. Each phase is tasked with answering a specific question
Pre-clinical research is the initial phase of the clinical trial in which a doctor has a research theory which must be proved in a laboratory before he can proceed to human testing. It must be first tested in laboratory animals and proved to be effective. This stage can take years to happen. If it is successful the next step is to file an Investigational New Drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”) for permission to study the treatment in people. The application must be approved in order to proceed to the next step. Throughout all these steps the information collected concentrates on the dose, safety and how well the treatment works.
Phase I involves a small number of participants – usually about 10-30 people- testing the treatment. All treatments that are now in clinical practice have been tested in a Phase 1 clinical trial. Patients enrolled in Phase 1 trials can be the first to get a new treatment option. This part of the process can last several months to a year.
Phase II clinical trials are conducted on a larger group of patients usually 30- 120 patients. At this point the safety and how effective the treatment is working on a specific cancer is measured. This can be done with specific blood work, or measuring the tumor size. It can take about 2 years to complete. There can be different arms of the trial. Doses of the treatment can be different for certain groups of patients. This is referred to as randomized phase II trial.
Phase III clinical trials test the treatment on a much larger group of patients. The number of patients can be more than 300 to as many as thousands of people. At this point it is important to have participation from different ages, sexes, and cultures to study the side effects and possible benefits of the treatment options. This phase can take years to complete. Comparisons are made between two or more treatment options. At this point if the data is positive and the treatment works well, an application for approval to the FDA can be made. If approved by the FDA, the treatment is typically for a specific cancer and a specific use.
Phase IV clinical trials are done after the treatment is being used. The purpose is to gather more information on safety and side effects over a longer period of time.
Clinical trials involve a team. Members of the clinical trial team include the Principal Investigator, research nurse, data manager, staff doctor or nurse. All have very specific roles in the different phases of a clinical trial.
Clinical trials can be sponsored by the government, non-profit organizations, drug companies, hospitals and academic medical centers.
All participation in clinical trials is voluntary. Information must be disclosed to the participant in an official form listing the possible side effects and risks to the participant. The form is called Informed Consent.
The latest figures involving participation by cancer patients in clinical trials estimates that only 3% of patients with cancer enroll in a clinical trial.
Advances in treatment for mesothelioma can only happen with successful clinical trials. To find out more information to see if you or your loved one qualifies you should ask medical personnel experienced in treating mesothelioma.
MesoLawyersCare works with highly experienced mesothelioma nurses who can help answers questions you have about mesothelioma clinical trials, treatments and surgical options. Contact MesoLawyersCare for more information and to get connected with an experienced mesothelioma nurse who can help you.
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