Researchers: Increased Online Chatter Could Jeopardize Clinical Trials

July 31, 2014 in News

Drugmakers and researchers have raised concerns that the growing use of Facebook groups, online forums and other social media by clinical trial participants could jeopardize trial results, the Wall Street Journal reports.

According to the Journal, clinical trials used to develop new treatments for decades have followed a central principal that both researchers and participants must be “blinded” to who is receiving experimental drugs and who is getting a placebo or standard treatment.

However, patients participating in trials for hepatitis C, multiple sclerosis and Amyotrophic lateral sclerosis have turned to social media websites to share their experiences. For example:

  • Patients have shared details of possible drug reactions online and attempted to discover whether they were receiving the active drug;
  • Patients have exchanged tips on ways to get accepted for trials even if they do not meet all of a trial’s requirements; and
  • Some participants have collected and analyzed their and others’ medical data to try to determine whether the treatments will be successful.

Researcher Concerns

Such practice has some drugmakers and researchers concerned about patient safety and the integrity of trial results. For example, the researchers worry that:

  • Patients may drop out of trials because they believe they are not receiving an experimental drug;
  • Patients may report inaccurate symptoms because of others’ influence or suggestions; or
  • FDA could refuse to approve a drug if it has doubts that the study was “blind.”

Craig Lipset, head of Clinical Innovation at Pfizer, said that patients who share too much about the trials “could effectively chill a new drug before it ever gets to patients by misinterpreting early signals.”

According to the Journal, so far no clinical trials have been halted as a result of patients sharing their experiences online.

Patient Perspective

Despite the potential consequences, clinical trial participants argue that they have a right to discuss and share such information.

Jeri Burtchell, a multiple sclerosis patient who blogged about her experience in a trial for an experimental therapy from Novartis, in a blog post wrote, “If I’m going to be poked and prodded, I’m going to be here blabbing about it.”

After having a conversation with Burtchell about the information she posts, Lipset said she made him realize that the researchers have to change, not the patients. He added that she reminded him that “ultimately patients are human beings. They are going to talk.”

Addressing the Issue

In an effort to address the way patients share clinical trial information, some drugmakers have begun including disclaimers in their consent forms, warning patients about the dangers of sharing too much information online.

However, drugmakers say the practice of sharing such information does not disqualify a participant.

Meanwhile, Burtchell recommended that drug companies establish their own online forums where patients can get their questions answered by experts and discuss issues with other patients in a moderated setting (Dockser Marcus, Wall Street Journal, 7/29).

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