Cancer Drugs, Clinical Trials, and Regulatory Agencies

Abstract

The treatment of cancer, including Head and Neck, often requires powerful medication which needs to undergo a rigorous development and evaluation process. This complex interaction between basic scientists, clinical investigators and the pharmaceutical industry is largely overseen by the Food and Drug Administration (FDA). The FDA must regulate the medications approved in the United States for the safety and benefit of the patient. Therefore, a comprehensive and detailed approval process has been developed over the last several decades that attempts to assure proper drug evaluation without undue delay in approval of these vital products. The elaborate process begins with preclinical trials where investigational medications are tested in animals to assess whether there is predicted benefit and safety in humans. When the medication is deemed safe enough to evaluate in humans a lengthy process of three phases of clinical trials begins. Each clinical trial phase has specific goals and requirements allowing progression of the drug towards approval. When it comes to testing and utilizing these medications for head and neck cancer patients there are several important ethical issues to consider. These issues include that these medications are usually only tested in patients who have tried and failed already approved treatment regimens, placebos should not be used in this patient population because it is not ethical to give these sick patients no treatment at all and patients that cannot participate in the clinical trial due to the very specific requirements of many trials may be able to access the investigational medication through a protocol process. Investigators in head and neck clinical trials are responsible for looking out for the needs of these very ill patients. It is a delicate balance to maintain proper clinical care and still conduct trials to search for better drug treatment regimens. An investigational review board is used to review and oversee clinical trials to make sure the trials are being completed properly and in the best interest of the patients. In instances where the trials show positive results, the developers of the drug will seek FDA approval to be marketed for specific clinical uses. This entire approval process is followed by surveillance of the drug even after it has reached the clinical use market. Although the FDA is charged with the task of careful consideration of all new potential cancer drugs there is some controversy as to whether this process actually slows clinical use of certain drugs in the United States. Whether a clinician is considering using a new cancer drug or an investigator is looking for the next hopefully better drug, knowledge of the FDA process of trials and drug development is vital to understand.