social media – TrialSphere

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

Technology is allowing people to connect and cultivate relationships in very exciting ways. Billions of people are using social networks to stay in touch with their friends, family and colleagues. But what type of relationship will social media & clinical research have?

Mainstream social media websites and clinical Research Professionals have started to get acquainted with each other. Some Research Professionals have climbed on board and created pages to promote their sites and currently enrolling studies. Research Volunteers are able to follow the sites updates, engage via instant message and email etc. This constant “real-time” type of communication should be extremely helpful with study recruitment & following up with study volunteers (recruitment & retention). But so far, it really isn’t.

One of the major challenges could be that many Research Volunteers don’t want to co-mingle their personal lives with their clinical research participation. With these social networks creeping into nearly every part of our lives, along with changing privacy policies, people are hesitant to engage researchers. No one wants to broadcast the fact that they joined a research volunteer “Group” and want to receive updates for a specific (and possibly stigmatizing) medical condition. Especially not to their friends, family and colleagues.

Another challenge faced by Research Professionals is that although the FDA has provided some guidance regarding the use of social media, specific guidelines on it’s use in clinical research have been limited.

“Static” websites designed to promote research opportunities have been around for over a decade. Many websites allow Research Volunteers to submit a questionnaire with their contact information, which is then forwarded to Research Professionals by the website’s administrator (usually charging a fee). But after the message is sent, the site may or may not follow up with the referral. Research Volunteers may change phone numbers, move or change email addresses. Many different scenarios may lead to the dreaded “Lost To Follow Up” status. Further, in the event that a Research Volunteer doesn’t qualify for a particular study, research site’s may not have dedicated staff who have the time to keep complete and accurate volunteer waiting lists.

TrialSphere.com aims to remedy these specific recruitment & retention challenges which can stand in the way of medical innovation and progress. Exciting new treatments can be lost because of the cost associated with clinical trial recruitment & retention. Research Volunteers may register on Trialsphere using only a valid email address which is not visible to other users. Any personally identifiable information must be intentionally provided by users to Research Professionals. TrialSphere is designed as a platform to discuss general research-related topics, ask questions, learn, connect and keep in touch. Logging into Trialsphere each day offers Research Professionals the ability to establish and cultivate relationships with Research Volunteers. Through familiar tools such as instant messaging, email, forums, comments, likes, follows & groups, researchers can now engage in a way which hasn’t yet been available to them. Research Professionals can also maintain their own TrialSphere blog and discuss topics which are important to them. Research Volunteers will always have free access to TrialSphere. If you are a Research Professional, try it out for free. We won’t charge you a dime until you’ve connected with 5 Research Volunteers.

We’d love to hear your thoughts. Please share your comments below.