Biopharma searching for right balance in addressing social media use by trial participants

The Wall Street Journal turned its attention this week to researchers' long-standing concerns about the consequences of patients talking about clinical trials online. And while the feature covers familiar ground such as worries about unblinding and manipulating inclusion/exclusion criteria, it also digs into how biopharma companies are tapping technology to counter these concerns.

A popular approach among biopharma companies in the early days of the social web was to simply stay off blogs, forums and other platforms on which patients communicated. While this eliminates the risk a researcher will see an adverse event that needs reporting to the FDA or a comment that could influence the clinical analysis, it does nothing to stop patients unblinding the trial by trying to work out whether they are taking the experimental drug or placebo.

Some trial participants have always tried to answer this question, but before the Internet these people had little influence over the rest of the trial. Now, with online comments on reactions to the drug--or placebo--potentially reaching all participants in the trial, biopharma is realizing it must be more proactive. "The industry needs to do a lot more," Joseph Kim, formerly of Shire ($SHPG) but now senior adviser, clinical development innovation at Eli Lilly ($LLY), told the WSJ.

Shire is one of the companies doing work in this area. The company partnered with Boston-based nonprofit the Center for Information and Study on Clinical Research Participation to create videos on the consequences of sharing information online. In the videos, animated beans explain the purpose of inclusion/exclusion criteria and the consequences of discussing side effects with other subjects. The videos could prevent problems before they arise by improving patient understanding of trials.

People will always want to discuss big events in their lives with individuals who are going through similar situations. Biopharma now faces the challenge of trying to discourage aspects of such talks that threaten the integrity of clinical trials without alienating patients. "It is a hard thing to modify behavior without it being too controlling," Kim said.

- read the WSJ feature (sub. req.)