No one who signs up for a clinical trial wants to be placed in the placebo group. Placebos are like our savings accounts, our daily workout, why we wash dishes: the end result justifies the means. That doesn’t mean we have to love the process. In fact, the fear of being placed in a placebo group is why some people avoid clinical trials all together.
To really know if a drug is working, researchers have to study groups of similar people, where the only difference is the drug being tested. That way, any differences in outcome can be clearly attributed to the experimental treatment. This is achieved through randomization – randomly assigning clinical trial participants to groups that receive the treatment, or groups that don’t, also known as receiving a “placebo.”
“The purpose of clinical research is to provide clear answers to patients, physicians and regulators alike,” says Erik Pulkstenis, Ph.D., vice president of data and statistical sciences, AbbVie. “Historically that’s been done using randomized placebo-controlled studies because of the comfort they provide with respect to interpretability.”
But what if, in some situations, we could substitute a traditional placebo group with a “synthetic control arm” that includes pre-existing data?