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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.”
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
