Tag: placebo effect

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Social Media, Clinical Research & Unblinding

A new challenge has been presented to researchers conducting placebo controlled studies:  The potential of social media unblinding a clinical research study. 

But, what is unblinding?

Unblinding is when either a volunteer or a clinician become aware of which treatment the volunteer is receiving.

Being “blinded” to whether someone is receiving active study drug or a placebo (i.e. “sugar pill”) is necessary to determine if a treatment is effective. In order for FDA to approve a new medication, they need  evidence that it can treat disease symptoms more effectively than a dummy pill. Interestingly, a dummy pill is often quite effective at treating a number of medical conditions, though the reason for this is still unclear.

If someone believes they are receiving treatment that will make them feel better, often times they do feel better. So much so that the disease may slow down or even go away completely. If a researcher knows that a participant is receiving active study drug, they may be inclined to interact with them in such a way as to amplify the effect of the drug (i.e. “I definitely think you’re getting better.” or “This drug is promising. I expect you to improve soon”. This bias can skew the study data, rendering it worthless. This is why the “blind” must be maintained if we are to understand the drug’s value.

Research Volunteers are now able to connect and communicate with each other using faster technologies which speak to broader audiences. The risk of research volunteers sharing sensitive study information has always existed, whether volunteers are talking among themselves in a waiting room, attending support groups or, more recently, engaging in conversations on Facebook, Twitter, or health-oriented online communities. The exchanges are typically not moderated and many tech savvy Research Volunteers are understandably eager to share their experiences with others.

Scenario
A research volunteer participating in an online forum may share that they received an injection at their randomization visit in which they experienced no side effects. Meanwhile, another forum participant may share that the injection they received gave them a burning sensation when  administered. The two can engage in conversation about their experience while trying to determine who is receiving study drug and who is receiving placebo. This scenario could jeopardize the blind and once this information hits the internet, there is usually no way for anyone to come along and remove their comments or posts.

This is a real concern and it’s happening now. See The Wall Street Journal July 2014 article – Researchers Fret as Social Media Lift Veil on Drug Trials.

The Center for Information and Study on Clinical Research Participation (CISCRP) has also produced some short, volunteer-facing videos which attempt to educate Research Volunteers on this problem.  Also, some Informed Consent Forms now contain language warning volunteers against sharing study-related information over the internet.

Even with these measures in place, the exchange of study related information may be difficult to stop. While education may be helpful, there is no guarantee that people will comply or fully understand the issue of sharing sensitive study information. If a health-related website took initiative and attempted to moderate comments and posts from their users, those users can always create their own community with no moderation or rules.

“The FDA is going to have to figure out how to accommodate social media.”

– Richard Garr – President/CEO Neuralstem Inc.

While TrialSphere seeks to bridge the communication gap between Research Professionals & Research Volunteers, we understand that the information shared through forums, messages and comments could be sensitive.

Comments and posts are moderated by TrialSphere staff members who have years of experience working in clinical research. We have also added the ability for all Research Professional members to moderate the material posted by any Research Volunteer members. If a Research Professional comes across a comment or post by a Research Volunteer that looks like it may contain sensitive study information, that Research Professional may flag it for deletion. Research Volunteer members are made aware of the possibility that their posts and/or comments may be deleted by Research Professional members, in the interest of preserving the integrity of the study data. Research Volunteers seem to be understanding of this.

We know that this issue is an ongoing discussion and we welcome your questions and comments below.

If you would like to learn more about Social Media, Clinical Research & Unblinding, check out:

Society For Participatory Medicine – Website

Nature Medicine – Engage with research participants about social media – Article by Craig H. Lipset, MPH – Head of Clinical Innovation Within Worldwide Research & Development at Pfizer

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Placebo Effect

Ah, the placebo effect. Some of you may have heard of it. For those of you that haven’t, it’s a pretty fascinating thing.

Have you ever thought about something, and then noticed that your body had an actual physical reaction? For example, if you focus hard enough on something REALLY sour, you can make the inside of your mouth start to water.

This can happen with our physical and mental health too. Most people wouldn’t suggest that an illness will go away simply if you think about it hard enough. But, no one disputes the fact that our thoughts can impact the severity of illness-related symptoms that we experience.

People with various medical conditions or illnesses can actually improve based only on the belief that they are receiving a medicine. This medicine usually has no biochemical effect on the body. It is a dummy pill, sometimes known as a sugar pill or a placebo.

Many clinical research studies will use a placebo in a certain percentage of volunteers. The placebo serves as a comparison to the investigational treatment. The FDA often requires that a medicine is shown to be more effective than a placebo, in order for it to be approved.

In order to get a clear picture of how effective a medicine is or isn’t, it’s important that both the researcher and the volunteer remain “blinded” to who is receiving study medicine or placebo. This a called a “double-blind placebo controlled clinical trial”. This type of trial helps to prevent bias. For example, if a researcher knows that a volunteer is receiving active study medication, they may assume that the volunteer is getting better. That researcher then carries that bias into all interactions with the volunteer and also may not report the volunteer’s symptoms as accurately. Alternatively, if a research volunteer knows they are receiving an active medication, they may be more likely to report an improvement or side effects that they otherwise would not have noticed.

Clinical research studies are carefully designed to avoid the possibility or “unblinding”, or exposing which medication the volunteer is taking. The chance of unblinding could increase if a volunteer shares too much about their experience with a study medication to another volunteer or the researcher. This could occur on TrialSphere, Facebook or even in the clinics waiting room. In order to minimize this possibility, TrialSphere Research Professional members have the ability to moderate comments and posts made by Research Volunteer members. If a comment is made in the forums or on an article and it could expose sensitive research study data, Research Professional members are encouraged to remove it.

If you’re a Research Volunteer and something you posted gets removed, please don’t take it personally. Clinical research and social media is a relatively new arena and we are doing everything we can to promote open communication between researchers and volunteers, but not risk the integrity of a whole study. Please feel free to chime in below!

TS