Jun 25 2012

Clinical Trials in the Facebook Age

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On 07 Jun 2011, Pfizer initiated a clinical trial pilot to assess safety and efficacy of Detrol LA, which is a treatment for overactive bladder (OAB).  The trial, REMOTE (Research on Electronic Monitoring of OAB Treatment Experience), was the first completely “virtual” trial ever designed.   The trial was set-up to compare if a completely virtual trial could replicate the results obtained from a traditional trial.  Patients were to be recruited through online patient communities and web-based advertising on sites like Craig’s List and Facebook.  Potential subjects would then visit a website that explained the trial and also allowed enrollment.  Study material, including medications, was to be shipped to subjects at their homes, and an app was designed to allow patients to keep diaries and report outcomes electronically.  The goal was to obtain faster, better quality, and more reliable results.  Briggs W. Morrison, M.D., Pfizer’s senior vice president of Worldwide Medical Excellence said, “This program and similar programs that may follow could lead to an entirely new way for patients to participate in trials and contribute to biomedical research.”

As of 11 Jun 2012, REMOTE stopped recruiting patients.

According to Craig Lipset, the head of Clinical Innovation at Pfizer, there were thousands of hits to the informational websites, but the rates of those patients subsequently expressing interest and actually enrolling in the trial were very low.  Lipset suggests that there is potentially a level of trust that is absent when the patient is not receiving trial information from their physician or another patient.   Additionally, Lipset admits that OAB, an non-life threatening indication for which there are already many treatments, may not have been the best disease to target.  So where does that leave the use of social media in clinical trials?

There have been other trials that have successfully used social media to increase enrollment.  In 2010, the HIV Vaccine Trials Network successfully ran ads on Facebook to help recruit patients for an HIV Vaccine study.  In 2011, the Mayo Clinic used a patient-run website to reach out to patients with spontaneous coronary artery dissection (SCAD) and successfully enrolled the full clinical trial for the rare disease within a week.  There have been other success stories, and nearly all target a rare or potentially life-threatening disease (HIV instead of OAB) and have an organized and demographically favorable patient population.

A recent survey from PWC found that community– or patient–run health sites had 24 times more social media activity than any of the health industry companies did.  Additionally, the survey revealed that while 24% of all survey responders have used social media to post about their health experiences, over 50% of those between the ages of 18 and 24 have.

The FDA, although intimately involved with the design of REMOTE and an advocate of innovation in clinical trials through the Clinical Trials Transformation Initiative, has been notoriously quiet on the use of social media in clinical trials and drug regulation.  One guidance has been released regarding social media, and that only discusses the FDA’s recommendations for responses by pharmaceutical companies to unsolicited requests for off-label information.

Even though REMOTE as a whole was unsuccessful, the trial was designed in a module format, and Pfizer will likely integrate the successful modules into future trials.  For now, the best way to harness social media’s power is likely through online patient initiatives, but as the social media-savvy early-20s demographic ages, we will likely see increases in the success rates of enrolling for and potentially even running clinical trials based on social media outreach alone.

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