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Why are we doing a Randomized Placebo-Controlled Blinded Trial?

Randomized placebo-controlled blinded clinical trials (RCTs) give us the gold standard of proof of what therapies and treatments work. RCTs are studies done in such a way that as many sources of bias as possible are removed from the process.

Basically, scientific errors of the past have taught us where we can go wrong by drawing false conclusions from our research. RCTs are designed to remove these major problems.

In most RCTs, the goal is to decide if a specific therapy actually makes a positive difference to the people getting it. To figure out if it does, researchers need to compare:

Did the women who took a new drug do better than those who received a placebo, that is, a sugar pill?

The “control group” is the group that doesn’t get the new treatment (e.g., they may get an older treatment or a placebo). They are the benchmark, the standard we measure against. Researchers testing a new therapy or drug hope to show that the people getting the new treatment end up much better off than those who were in the control group.

Blinding means that neither you nor the researchers know what you’re getting. This allows the researchers to measure the physical effects of the treatment independently of your and the researcher’s expectations and beliefs about the value of the treatment. We also do it this way because sometimes people can have response to a placebo (called the placebo effect). This response can be positive or negative. So, it’s important that neither you nor the researchers know what group you’re in.