To assure medications put on the market in the United States are safe and effective, the Food and Drug Administration (FDA), a branch of the United States Department of Health and Human Services, regulates clinical trials. The FDA began overseeing the safety of new treatments in the late 1930s and started requiring proof of effectiveness in the early 1960s. Before drugs are even considered for a clinical trial, they have to be discovered, purified and tested on cells and animals. According to the American Cancer Society, about 1,000 potential drugs are tested before just one reaches human clinical trials. A new cancer drug takes an average of six years to research before it reaches clinical trials, and then an average of eight years to make it through clinical trials.
Under the FDA, clinical trials are governed by a plan called a protocol. The protocol specifies which patients may enter the study, the schedule of tests and procedures, dosages, the length of the study and the outcomes to be measured. To measure the safety and effectiveness of new medications, researchers measure the outcome of a group given the drug to a group receiving a placebo, or an inactive pill, liquid or powder. Clinical trials take place in four stages, or phases. In phase I, researchers test a drug for the first time on a small group of people to determine dosage and identify side effects. In Phase II, the drug is given to a larger group of people to test its effectiveness and safety. In phase III, the drug is given to large groups of people to continue measuring its effectiveness, monitor side effects and compare it to commonly used treatments. Phase IV takes place after the drug is put on the market. In this trial, researchers gather more information about the drug's risks, benefits and best use. It's easy to see why trials are a time-consuming process.
SAFETY ... OR BARRIER? Although clinical trials help to ensure the safety of new drugs, some criticize the way they are carried out. Others believe certain medications in phase I of clinical trials should be made available to patients who have exhausted all other treatment options. One organization representing this point of view is the Abigail Alliance, named for a 21-year-old woman who died of cancer in 2001. This year, Senator Sam Brownback introduced a bill in accordance with their cause. The ACCESS Act would make an exception for terminally patients, allowing them to receive experimental drugs still in the first phase of trials. Members of the Abigail Alliance believe, "No seriously ill person should have to die merely because the FDA stamp of approval on a drug is years away."
Those against the bill say it's important to consider the purpose of clinical trials; namely, that of weeding out drugs shown to be ineffective or even dangerous for humans. "In fact, statistics show that 90 percent of all drugs that pass phase I testing are ultimately shown to be ineffective or too toxic," Colin Begg, Ph.D., a board member of the Society for Clinical Trials, told Ivanhoe. Fewer than five percent of adults with cancer will take part in a clinical trial, and experts against the access law worry it would lower that number even more, making it difficult to recruit participants and develop new treatments.
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