The Placebo Effect in Clinical Trials: What to Know

There is evidence that the mind can affect healing. People often feel better simply by believing that they feel better. This mind-body healing phenomenon is sometimes called the placebo effect. When setting up a clinical trial to determine the safety and efficacy of a new treatment, it is essential to distinguish between a placebo effect and therapeutic improvement.

What is Placebo?
A placebo is usually a sham or inert medicine, such as a sugar pill. Patients given a placebo believe they are receiving treatment and will often report improvement. Sometimes, it is not even necessary to dispense the sham medicine. Some patients begin to feel better just knowing that they are under a physician’s care or part of a study.

The Problem with Placebo Effect
The problem with the placebo effect is that it can mask therapeutic outcomes in research studies. It can be difficult to determine if the patient improvement is the result of the study drug or placebo. A patient may not even need to receive a placebo for the effect. For example, a study patient enrolled in clinical research may convince themselves they feel better just by participating in the study. They want or expect to see a positive outcome, and as a result of that mind-body connection, they feel better.

Placebo Effect on Research
Research administrators may also influence patient outcomes by how they interact with the study subjects. Patients may unknowingly respond to the perceived expectations of the study administrators. Double-blind controls ensure that neither the study patients nor the study administrators know who is receiving a placebo or the study drug.

It may be necessary to take extra precautions to ensure a blind control group. Not all placebos are inert. Sometimes the study drug has known side effects. A placebo is needed to mimic the known side effects of the study drug. The intent is to prevent the study subject from “guessing” that they are part of a control group. If a patient believes they are not receiving treatment, it may cause a negative placebo effect. The patient may convince themselves that they are not feeling better.

Distinguishing Therapeutic Outcomes from Placebo
The powerful connection between the human mind and healing is complex. Yet, while a placebo may make a patient feel better, there is no evidence that it can shrink a tumor or cure disease. Therefore, it is critical to design research to distinguish significant therapeutic outcomes from a placebo effect.

Altus Research and Clinical Trials
Altus Research understands the importance of designing research studies that distinguish between therapeutic efficacy and the placebo effect. Altus Research, located in Lake Worth, FL, has conducted clinical trials since 1996. It works closely with major pharmaceutical companies and private medical practices on Phase I, Phase II, Phase III, and Phase IV clinical trials. If you are interested in participating in a clinical trial, please complete the online contact form to schedule a consultation appointment.

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