Before the Food and Drug Administration (FDA) grants approval to a medicine or drug, tests have to be performed to prove both the safety and effectiveness of the new treatment. Clinical trials on actual people can only begin after extensive animal and laboratory tests.
Clinical Trial Phases
Clinical trials progress through four separate phases:
- Phase I trials examine the new treatment’s safety. Side effects are identified. Only 20-80 individuals participate.
- Phase II trials continue the work done in Phase I, with a larger group of patients.
- By Phase III, up to 3,000 people may be participating. Phase III determines the drugs effectiveness, and how well it works compared to older treatments.
- Phase IV trials occur after the FDA approves the drug, in order to monitor the treatment’s long-term effectiveness.
Why Volunteer for a Clinical Trial?
You gain access to new treatments quickly, and long before the general public. You receive the medication for free during the trial, and often for months after the trial. The doctors monitoring your condition will be leaders in their fields, allowing you to access the most informed medical care. Some facilities will even pay for your time.
By volunteering, you’re not only taking control over your own health, you’re also helping others who will benefit from the clinical trial’s results.
Are There Risks?
Well, yes. That’s one reason the FDA insists on clinical trials. The medical treatment may cause unforeseen side effects. There’s always the possibility that the treatment will have no effect on your condition. A clinical trial will also take up some of your time. You can leave a clinical trial at any time (although the researchers would probably appreciate it if you explain why you’re opting out). Also, your rights as a trial participant are outlined by the World Medical Association’s Declaration of Helsinki.
There is the possibility that you may be given a placebo (an inactive pill) instead of the drug being studied. To properly evaluate the drug’s effectiveness, it’s important to have a control group: a group of patients who aren’t receiving the medication.