You’ve likely heard of the “placebo effect,” a phenomenon that occurs when researchers study participants in a control group. In clinical trials, control groups typically receive an inactive substance that looks like the drug or treatment being tested, i.e., a placebo. Sometimes known as a “sugar pill,” placebos play an important role in helping researchers determine whether or not a treatment is safe and effective. For maximum trial efficacy, many researchers conduct “randomized, placebo-controlled” clinical trials. Read on to learn more about the implications of the placebo in clinical trials.
The Placebo in Clinical Trials
What Is a Placebo?
A placebo is an inactive drug or treatment used in a clinical trial. It mimics the treatment being tested without actually delivering any effects. For example, a trial participant in a study testing a new eczema cream may be placed in a placebo group, which means they would receive an unmedicated cream that looks identical to the medicated cream being tested. Placebo-controlled trials compare new treatments with a placebo to determine whether a treatment is effective or not.
What Is the Purpose of the Placebo in Clinical Trials?
A placebo-controlled trial allows researchers to compare results from the two test groups: the control group receiving the placebo and the group receiving the treatment. The comparison helps researchers determine whether any symptom changes are a result of the treatment, or if they occur by chance. Clinical trials that use placebos typically require a “blind” study, in which participants, family members, and even clinic staff all are “blind” to the treatment – meaning even the clinicians are unaware of which participants have received the placebo.
What Is the “Placebo Effect?”
The mind can affect the body in powerful ways. The term “placebo effect” refers to a phenomenon in which a participant believes they are receiving an actual treatment. This can, in some cases, make participants feel better as if they’re responding to a treatment. This can also involve negative side effects, when participants begin to feel poorly because they expect side effects – even if they’re receiving placebo treatment.
Do Placebo Trials Carry Any Ethical Concerns?
Placebos are an essential part of the clinical trial process. However, clinicians must proceed ethically and transparently when running placebo trials. In 2019, the Office for Human Research Protection (OHRP) published updated guidelines for the use of placebos in trials. These guidelines outline several principles for ethical placebo trials:
- Pediatric Trials: The use of placebo treatment in children is much more restricted than in adults. When doctors use pediatric placebos, they must exercise utmost transparency and care to protect the participant
- Participant Communication: Participants must understand the rationale and goals of the trial before it begins. While participants cannot consent to receive a placebo specifically, participants must understand the likelihood of receiving a placebo before entering the study.
- Participant Safety: Doctors should never use placebos as a means to withhold effective treatment, particularly for participants with serious and life-threatening conditions. In these cases, placebo treatments should be used in addition to standard care.
- Withdrawal Criteria: Placebo trials must have explicit withdrawal criteria built in. This allows subjects to remove themselves from prolonged placebo treatment if they experience ongoing negative effects.
Placebos are a crucial aspect of clinical studies, providing researchers with a helpful and neutral comparison point. Ultimately, ethical placebo trials hinge on thorough participant communication, built-in medical safeguards, and rigorous testing standards.
Have you ever thought about participating in a clinical trial? QPS Missouri is looking for new participants. Since opening its doors in 1994, QPS Missouri has conducted over 1,000 FDA-regulated studies, paying out over $35 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. This includes several pediatric studies across several age ranges. If you would like to join us in this crucial healthcare mission, consider applying for a clinical trial.
To get started, you simply need to fill out an online application. Within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. Finally, to learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of frequently asked questions.