Clinical trial sponsors, investigators must now account for social media in study designs

The Pink Sheet is a newsletter on the pharmaceutical industry read by many drug manufacturers. One recent issue had a report discussing the impact of Social Media, such as Facebook, on the design and execution of clinical trials.

You can read the whole story here: Social Networks in Clinical Trial Design

Clinical trials, in particular the all-important Phase 3 Pivotal trials, cost many millions of dollars to execute. They are designed meticulously, especially when it comes to blinding and randomization controls. Study subjects can’t know whether they took the study drug, the placebo (or, if applicable, the comparative drug) until after the trial is completed. If they did, they might not react naturally or adhere to the study protocol, and the trial results could be compromised.

Derrick Gingery reports:

Craig Lipset, Pfizer senior director in clinical research, said patients are using chat rooms and forums directed at specific diseases, in some cases talking about the clinical trials in which they are participating and their experiences with the study drugs. The online talk could threaten a trial’s blinding and randomization, especially as patients are more able to interact with other trial participants, he noted.

At the same time, as Lipset says later in the story, asking clinical trial subjects to refrain from using Social Media is not realistic. Recruiting subjects for clinical trials and getting them to follow existing protocols is hard enough as it is. So trial sponsors and investigators need to account for these tools in designing clinical trials.

Lipset’s employer, Pfizer, took a step in this direction this past June by conducting a virtual clinical trial for the long-acting formulation of Detrol LA. Other drug sponsors, investigators and CROs (contract research organizations) will likewise need to design clinical trials with Social Media in mind.

At the same time, researchers and pharmaceutical companies can also use Social Media to their advantage. While comments on a Facebook page or an internet message board are not statistically reliable or a substitute for the FDA’s adverse events reporting guidelines, they can provide hints of problems  before they become catastrophic public relations disasters. On a more positive note, sponsors can, as Gingery reports, tap into social media to recruit subjects for clinical trials.

 

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