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Thinking About Participating in a Clinical Trial?
Before a drug can be prescribed in the United States it must be approved by the Food and Drug Administration (FDA). The United States has the most stringent drug approval requirements in the world. The lengthy approval process requires that a drug’s manufacturer conduct a number of tests of the drug’s safety and efficacy (effectiveness). The tests that are performed on humans are called clinical trials.
Each year in the U. S., tens of thousands of volunteers participate in such trials.
The San Francisco Clinical Research Center conducts from 30 to 40 clinical trials a year.
One reason people volunteer for trials is to receive experimental treatment before it is available to the general public. Another reason is to help further medical research.
PRECLINICAL TRIALS
When a pharmaceutical company discovers a promising new drug, that drug must undergo extensive laboratory investigations of its primary physical and chemical properties. There tests are followed by tests in animals. These 2 types of tests are called preclinical trials.
CLINICAL TRIALS
Drugs that still seem promising after preclinical trials may be tested in humans. Human testing occurs in 3 phases.
Phase 1 In its first human tests, a drug is given to a small number of patients or to healthy people. The SFCRC does not conduct Phase I studies. The main purpose is to test the safety of various doses and to assess side effects. These trials can also study how long drugs effects last and how long the drug stays in the human body. A drug may behave very differently in humans than it does in animals.
Phase II If all goes well, the drug moves on to phase II clinical trials, which may involve hundreds of patients. The main purpose of these trials is to study the drug’s efficacy against the disease or symptom it is intended to treat. Short term safety is also measured. Phase II trials are controlled clinical trials, which means that the participants are divided at random into groups. One group takes the drug. The other group, the control group might take a different drug or no drug at all. Instead, it might take a placebo, an inert substance that looks just like the study drug. The control group provides a standard against which the effects of a new drug are measured.
Most of our trials are double-blinded. This is done to make sure that the volunteers and the clinic staff do not overrate the drug’s abilities because they subconsciously hope that the drug will produce beneficial effects.
Phase III Phase III trials, which involve several hundreds to several thousands of participants, further test the safety and efficacy of a drug and provide data for the FDA to use in deciding what it’s labeling should say if it is approved. These trials may be either controlled or uncontrolled or either blinded or unblinded. Unblinded tests are open label, which means both the patient and the doctor know what treatment is being given.
The San Francisco Clinical Research Center conducts Phase II and Phase III trials.
POST MARKETING SURVEILLANCE
After a drug has been approved and is being prescribed, doctors and researchers track how well it is working. In the United States, the FDA maintains a postmarketing surveillance program called MedWatch that enables healthcare professionals, drug companies, and the public to report side effects via the internet, mail, or fax. Postmarketing surveillance is useful in detecting rare but serious side effects. Visit http://www.fds.gov/medwatch/ for more information on reporting side effects.
ENROLLING IN CLINICAL TRIALS
The FDA keeps a listing of trials open for enrollment at clinicaltrials.gov.
We conduct trials on a number of neurological conditions, including migraines and other headaches, Parkinson’s Disease, mild memory loss, Alzheimer’s Disease and other dementias, Post Herpetic Neuralgia, and Diabetic Neuropathy. To find out what studies we are currently recruiting for, call 415 673-4600.
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