Clinical trials measure efficacy of experimental therapies by comparing outcomes in patients receiving therapeutic interventions (treatment response) with patients receiving placebo (placebo response).
Topic: Placebo Response
A representative from Tools4Patient discusses how grasping the ties between the two can help in reducing the impact of the placebo response in trials.
Placebo response is a major source of noise in trial data analysis, muddying the results and making it more difficult to detect true treatment effect. We know that it’s a pressing problem for clinical trials that needs solving, but where does it come from in the first place? Patient psychology, expectations and baseline severity of the disease play a significant part of a patient’s placebo responsiveness.
When we think about patient characteristics that influence health, disease, and clinical research, we tend to think about things like vital statistics, medical history and genetic makeup – while patient personality or psychology is often overlooked. In reality, the importance of personality has been under scrutiny for centuries and dates back to Greek and Roman times
As in many other diseases (e.g. pain, osteoarthritis, rheumatoid arthritis, Parkinson’s Disease, etc ), patients participating in clinical trials for IBD treatments may experience a pronounced placebo effect or placebo response. As IBD is a chronic disease, efficacy is comprised of improvement rates as well as remission rates; unfortunately, both are influenced by placebo response, albeit at different rates.
Adjustment for covariates helps clinical trial statisticians demonstrate differences in drug effect between groups of people. In this blog, we discuss what this means and how it can help improve analysis and interpretation of clinical trial data.