What is a clinical trial?
Clinical trials are conducted to evaluate new treatments. The personal benefit for the patient who gets enrolled in a clinical trial is unpredictable. It lies in the nature of a trial that the outcome is unknown. The new treatment being evaluated may turn out to be more effective than standard therapies but this cannot be guaranteed.
Adverse reactions to the treatment under investigation are possible. Before a new treatment strategy is being evaluated in humans, extensive research is performed in the laboratory. Thus a large amount of data is available on how the new treatment works and what the possible side effects are by the time the clinical trial is started.
Phase I clinical trials
So called Phase I clinical trials are conducted to determine the toxicity (‘side effects’) and tolerated dose of a new treatment. Drugs that are used in a phase I clinical trial have not been used in humans before and thus adverse reactions specific to humans are possible. That is why phase I trials are conducted stepwise starting at relatively low doses. After each dose step the trial temporarily closes and a toxicity evaluation is performed. The study only continues at a higher dose-level if no serious drug-related toxicities have occurred.
Phase II clinical trials
Phase II clinical trials investigate the efficacy of a new drug or treatment protocol at the optimal tolerated dose as determined in a preceding phase I trial.
Phase III clinical trials
Phase III clinical trials compare the efficacy of a new treatment with a procedure that is considered standard of care or a ‘placebo’.
Enrollment in a clinical trial requires your permission. Your doctor may ask you if you are interested to participate. You will be given verbal and written information on the particular trial. Take as much time as you need to go through the material. Your doctor is available if you have any questions. There is no obligation whatsoever to participate and you can withdraw from the trial at any time. If you decide not to undergo treatment within a clinical trial, you will be offered a treatment considered ‘standard of care’.
Most of the time, cost of participation are covered by the institution conducting the clinical trial or a pharmaceutical/bioscience company. If coverage is required by your insurance company, we will assist you in determining prior to your enrollment if you insurance company is willing to do so.
Clinical trials are conducted by institutions such as the Yale Brain Tumor Center alone or in cooperation with national tumor consortia or pharmaceutical/bioscience companies. ‘Consortia’ are comprised of several cancer centers or dedicated Brain Tumor Centers throughout the United States.
The Yale Brain Tumor Center as part of the Yale Cancer Center is a member of the national tumor consortia RTOG and ECOG. Please refer to the website of these institutions for further information. For more information about the Yale Cancer Center please refer to its website. For more information on Clinical Trials in general please refer to the website of the National Cancer Institute.