Placebo and clinical trials

Notes Competing interests: None declared. References 1. Associated Press Release. FDA advisers endorse new drug for arthritis. Oregonian, national section. August 8, , p A Medical Informatics information package: leflunomide AravaJ. The continuing unethical use of placebo controls. N Engl J Med ; : Levine RJ. Ethical and regulation of clinical research. Professional integrity in clinical research. JAMA ; : Perceptions of cancer patients and their physicians involved in phase I trials.

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Accountabil Res ; 4 : Beecher HK. Ethics and clinical research. Support Center Support Center. External link. This usually occurs after weeks when enough information has been collected on how they perform without the new treatment. Most phase 3 trials are designed so that all participants will get access to the study drug before the trial ends. In most cases where a placebo is involved, you won't know if you're taking one, and it's often the case that your medical team won't know either.

This is because knowing what treatment participants are taking can affect the results of a clinical trial. For example, if a doctor running the trial strongly believes the new treatment is better than what's available today, he or she might subconsciously try to help sicker patients by putting them into the group that receives the new treatment. So at the end of the study when the team is looking at the results, it might look like the new treatment didn't work as well as the old treatment, just because patients who received the new treatment were already much sicker than the ones receiving the old one to begin with.

This can make the treatment look like it has worse side effects than it does. To make sure the results are accurate, doctors often use two methods called blinding and random assignment. Blinding is where one or more groups involved with the clinical trial don't know what treatment the participant in the study is receiving. Some of the groups that the researchers might want to prevent from knowing what treatments the patients are on include:.

Two common types of blinding are single-blind and double-blind. In a double-blind study, neither the patients, nor the medical staff treating the patient know which of the possible treatments the patient is taking. In a single-blind study, the researchers know what medicine each patient is taking but the patient does not.

Random assignment can be used to help make sure that the right groups are blinded in the study. With random assignment, patients are placed into a treatment group randomly. One way that participants are randomized is by using a computer to assign patients to groups. Programs that do this can make sure the investigational group and the control group to be as similar as possible in terms of age, sex, and other features.

Most likely, you won't know during the study if you're in the investigational group or control group, but once the trial is finished, all participants should be informed of which group they were placed in. In any trial where patients may receive a placebo, they will always be notified of this possibility during the informed consent process before joining a trial. This will cover any potential risks associated with the control group treatment, and what percent of patients are placed in a group that doesn't receive the study treatment.

So while you may not know if you are in a control group, the medical team will provide the details that allow patients to make an informed decision about whether participating is the right choice for their situation.

While the possibility of receiving a placebo can seem scary, remember that trials are designed with patient safety as the first priority. Part of the approval process with the FDA and IRB before a trial begins includes reviewing what treatment groups will be used.

If the possibility of receiving a placebo would be unsafe for any potential participants, the IRB withholds approval from the study. We believe that all patients should have the power to access the most advanced healthcare available and our goal is to make this process as seamless as possible. Adjusting to Cancer. Day-to-Day Life. Support for Caregivers. Questions to Ask About Cancer. Choices for Care.

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