What Is A Blinded Study?

When it comes to clinical trials and medical research in general terminology can be a barrier, preventing patients from being as informed as they should be. Informed consent is a major part of taking part in a clinical trial, but in order to give your informed consent you must be in on the jargon used by researchers.

We at FindMeCure don’t just want to inform you about your options and give you knowledge of what’s going on in the world of medical advancements. We want to empower you to make your own decisions, to take your health in your own hands and be an active participant in your own recovery process. This is why being educated in the basics of clinical trials is so crucial.

For some time now we’ve been posting about all sorts of things you might be interested in if choosing a clinical trial seems tricky because of the terms used for different kinds of trials. From the main purpose of a clinical trial to the method of research used, we’ve mostly covered the basics.

We even talked about randomization in clinical trials but until now we hadn’t really explained what ‘blinding’ means when it refers to the way a trial is conducted. Well, let us fill in the gap.

Blinded studies

The 20th century was marked by scepticism and disillusionment. The great ideology of positivism and the belief that exact science was always accurate, measurable and unbiased tumbled down. Philosophers of epistemology (the ‘how do we know what we know’ branch of philosophy) theorized that even empirical data extracted from controlled lab experiments can be skewed. The belief that numbers speak for themselves no longer held water when one considered how the results can be interpreted in different ways by researchers supporting different hypotheses.

As many of us know, there is no perfect method in science. However, there are some steps that can be taken in order to limit researchers from taking their own bias with them in the assessment of studies.

And this is exactly what blinding is – a way to ensure more objective results as well as more unbiased analyses of said results.

How is it done?

A blinded clinical trial means that one or more parties are unaware of the treatment being received. Usually, it’s the participants in the clinical trial that are “blinded”, meaning they don’t know whether they are being treated with the drug in development or a placebo. A placebo is an inactive substance given to a control group in order to asses the real drug in testing.

The logic behind “blinding” participants is that by not knowing whether they receive the drug or a placebo, the results they report are more authentic, since they’re not influenced by the belief of what’s supposed to happen to their bodies and how they’re supposed to feel.

Sometimes the staff administering the treatment, the physician responsible for the assessment of it or the people who interpret the results can be blinded too. By blinding the medical staff the team behind the clinical trial ensures that no one can accidentally reveal to the patients whether they’re receiving the actual drug or are in the placebo control group.

Types of blinding

So, there you go, now you know what blinding in clinical trials means. But what exactly is a double-blind clinical trial? And who is blinded in a single-blind study? Naturally, the types of blinded studies depend on the number of parties blinded. If everyone is aware of who gets what kind of treatment, the study is called unblinded or open label.

Single-blind are studies which blind only one party, usually those who receive the treatment;
Double-blind means that both the participants and the people who collect the data are in the dark about which treatment is received;
Triple-blind takes double-blind a step further – the people who analyse the collected data are unaware as well in order to ensure they interpret it objectively.

Disclosure

Also called unblinding. For you as a participant it might be nerve-wrecking not to know whether you receive the actual treatment or a sugar pill. However, when the clinical trial is blinded, the process of unblinding is described in the study protocol (the document where all the details about the trial are listed) and you give your consent to it beforehand.

Consent, however, can be withdrawn at any given moment. There is usually a process of unblinding the participant before the agreed upon time, all you need to do is read the documents thoroughly and communicate openly with the medical staff of the trial.

If now you feel more prepared to tackle the world of clinical research, you will find a variety of clinical trials to choose from on the search page of FindMeCure. If however, you don’t feel quite ready yet, keep reading our blog where we answer some of your most pressing questions about clinical trials and even review trials you might be interested in.