What is Blinding?
From the Desk of Dr. Danielle Meadows
Vice President of Research Programs & Operations
This month, I want to continue drilling down on some of the considerations that go into study design—the first stage of the research process—which contribute to how extensive of an undertaking it really is to launch a scientifically rigorous study.
One of the many aspects of scientifically rigorous clinical trials is blinding, so I’ll share a little bit about what blinding is, how it works, and some of the challenges we face with blinding in ME/CFS research.
The Heart of the Matter
- In clinical trials, there are different treatment groups that a participant gets put into when they start the trial. Blinding is when different people involved in the trial are kept unaware, or blind, to which group the participant is in.
- Blinding helps make a trial less biased because people aren’t able to behave or report things differently based on whether they are receiving a treatment or not.
- For a practical example, OMF’s Life Improvement Trial is a double-blind study—both the participant and the researchers don’t know whether the participant is receiving the drugs or placebos until the end of the trial.
Blinding is an important concept in clinical trials, contributing to the objectivity and scientific rigor of a research study.
What is blinding?
Blinding is a process in clinical trials where the treatment that a participant is given as part of the trial (e.g., the drug being studied vs. a control) is kept from specific people involved in the study. There are three main types of blinding for a research trial:
- Single-blind: In a single-blind study, the participant does not know which treatment they have been assigned.
- Double-blind: In a double-blind trial, both the participant and researcher are unaware of the participant’s treatment assignment.
- Triple-blind: In a triple-blind study, the participant, researcher, and data analysis personnel are all blinded to the assigned treatment.
In OMF’s clinical trial, the Life Improvement Trial (LIFT), both the participant and researchers are blind to each participant’s trial arm assignment, making it a double-blind study. Read more about the LIFT design in the protocol paper.
Why is blinding important?
Blinding is an important component of facilitating scientific rigor in clinical trials. It helps protect against various biases that often affect the results of the research, including performance bias, reporting bias, and observer bias. Blinding also helps to identify the placebo effect—when a person experiences a health improvement from a treatment that was designed to have no therapeutic benefit (a placebo).
Blinding in ME/CFS research can sometimes be complicated, particularly because many patients have tried a wide variety of treatments. It’s possible that a person’s prior experience with a treatment could help them identify whether they are receiving that treatment or a placebo. Therefore, study teams have to carefully consider how to mitigate that possibility.
How does blinding happen?
Blinding typically occurs during the randomization stage of a clinical trial—when participants are randomly assigned to a treatment arm based on previously determined factors. In order to achieve blinding, that randomization is done by a third party and the results are coded. For example, in the LIFT, randomization is done by the pharmacy distributing the drugs and the code is not released until after the trial is completed, leaving the researchers and the participants blind to their treatment assignment—a double-blind trial.
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