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Conversely, social media discussions about study requirements and procedures may discourage participation and undermine study integrity, according to experts at last week’s Drug Information Association (DIA) annual meeting in Washington, D.C.
That intriguing question raises important issues about how widespread patient sharing of information over the Internet can both support and undermine efforts to obtain meaningful results from biopharmaceutical research studies. Disease group chat rooms, instant messaging and Facebook pages can help recruit patients to clinical trials and make them feel part of a community making an important contribution to health and science.
Conversely, social media discussions about study requirements and procedures may discourage participation and undermine study integrity, according to experts at last week’s Drug Information Association (DIA) annual meeting in Washington, D.C. Online conversations by trial participants may skew enrollment, undermine blinding, and minimize or exaggerate adverse event reports, noted Craig Lipset, head of clinical innovation at Pfizer.
On the plus side, Lipset described how leveraging social media can generate wider patient input to design protocols with endpoints that matter most to individuals. Sponsors and CROs should engage patients on trial design and site selection well before recruitment, advised Eric Peacock, CEO of MyHealthTeams, which helps patient communities establish social networks. The key is to be sure that a study assesses symptoms most important to those familiar with a condition, that required tests are reasonable, and that patients understand terms such as “infusion” and specifics for handling and taking drugs.
Such efforts to gain patient input on study design, however, also encourage continued online conversations among trial participants, which can be problematic, Lipset commented. Individuals increasingly share advice on how to skew personal health information and adverse event experiences to meet eligibility criteria for entry into a study and to stay in the trial. Patient groups are going online to rate research sites and discuss study screening processes, inclusion and exclusion criteria, site locations and features, and support services, explained Lindsay McNair, chief medical officer of WIRB-Copernicus Group. This has become so mainstream, she noted, that there are even Yelp reviews of clinical research sites.
McNair described blogs by trial participants about side effects and reactions to treatment, and how these may spur a wave of similar complaints from fellow subjects that can exaggerate safety concerns about a test product. Online discussions also may offer advice to an individual experiencing a rash or other adverse event about what not to tell the investigator in order to stay in the trial, said Eric Peacock.
A notable trend is for study subjects to use social media to discover whether they might be in a placebo or treatment arm of a study. This may involve exchanging information on the taste or appearance of a pill, and even composition of crushed tablets. People post pictures of pills and lot numbers and comment on how viral load changes may indicate if one is on the drug, McNair pointed out, actions that may lead to unblinding and can compromise the integrity of a clinical trial.
While sponsors may want to monitor such conversations and interact with patients about their comments and concerns, such actions may be risky, Lipset noted. Providing advice on how online discussion may undermine trial integrity may only raise awareness among others that study-related conversations are taking place.