Mesothelioma Clinical Trials
Due to the rising number of cases of mesothelioma, the disease has attracted more attention in recent years, more research dollars are being spent to find new drugs and procedures in an attempt to halt the disease or treat its symptoms. Each year, research scientists dedicated to finding a cure and more successful mesothelioma treatmentoptions come up with new possibilities for addressing the disease and they need the help of volunteers to test their finds.
Sometimes, the process that takes a new drug from infancy to approval by the Food and Drug Administration (FDA) can be quite a long one. Before the FDA even considers use in humans, the drugs are usually tested on animals to be sure their use carries no serious consequences.
Once the drug is approved for clinical trial involving humans, study directors begin a search for patients who are willing to volunteer to test the new drug. By conducting clinical trials, doctors or researchers hope to discern proper dosages, potential side affects, and effectiveness of the drug in question before it is released to the general public. Some drugs will never be approved while others that show great promise may be rushed through the system in hopes of saving more lives.
Patients may benefit greatly from participation in clinical trials but there are risks involved and there is the chance that mesothelioma victims will see no change at all in their condition, even during or after the clinical trial. Anyone thinking of enrolling in these trials should understand the risks and potential outcome before agreeing to participate and should talk frankly with their doctor about what may be involved. Explore potential side affects (if available), determine the length of the study, and read any written literature carefully before signing any legal or medical papers associated with the trial.
Understanding the hierarchy of clinical trials may help you make an informed decision. Currently, the FDA guidelines for clinical trials are as follows:
- Phase I trials - Phase I clinical trials are generally quite small since researchers do not yet know the exact affect a drug may have on the human population. They usually involve approximately 20 to 50 patients from a very select group. Goals of this phase include the evaluation of the safety of the drug, dosage range, and potential side affects.
- Phase II trials - Once the Phase I trial has significantly established the safety of the new drug, it's time to test it on a larger group of patients. This phase determines how effective the drug is against a particular disease or group of diseases. Safety continues to be evaluated. Phase II study groups normally involve around 200-300 patients.
- Phase III trials - If a drug has successfully passed through Phases I and II, it is swiftly approaching approval. Phase III clinical trials usually compare the new drug to an established drug that has proven to be effective in the treatment of a particular disease or group of diseases. Once again, effectiveness and side affects will be monitored. A Phase III study group can include up to about 3,000 participants, allowing researchers to form a larger database about the new drug. Soon, when the drug is approved, this information will be released to the medical community and general public.
- Phase IV trials - These trials are post-marketing tests, done after the drug is approved to determine how it might work against other diseases and how to best use the drug.
Clinical trials test more than just new drugs. Each day, strides are being made in other areas that might benefit mesothelioma patients, such as new curative and palliative procedures, screening and diagnostic techniques, and prevention methods. These must be tested as well before they can be used by the human population.
Last modified: December 24, 2010.