Will Social Media Tools Transform Clinical Research?

Health IT Boosts Patient Care, Safety

Online communities in which patients monitor and submit data on the effects of novel drugs can accelerate pharmaceutical research by increasing the number of participants, and reducing the cost of conducting clinical trials. That's the conclusion of a study published last week in the journal, Nature Biotechnology.

The goal of the study, which was conducted with the help of a health data-sharing group called PatientsLikeMe, was to evaluate the validity of a 2008 report published by the Proceedings of the National Academy of Sciences, which claimed lithium carbonate could slow the progression of the neurodegenerative disease amyotrophic lateral sclerosis (ALS).

To do this, PatientsLikeMe built a lithium-specific data collection tool to capture information about the 348 ALS patients registered with the PatientsLikeMe website who began taking the drug off-label via their physician.

PatientsLikeMe also developed a novel algorithm designed to match patients who reported taking lithium with a number of other ALS patients that had similar disease courses. By using a matched control group, PatientsLikeMe was able to reduce biases associated with evaluating the effects of treatments in open label, real world situations and improve the statistical results of the study making each patients contribution more significant.

The results refuted the positive findings of the previous study. "Using our analytic approach and data-capture methodology, we have been unable to replicate previously described promising results of the efficacy of lithium to slow the progression of ALS," the report said.

"This is the first time a social network has been used to evaluate a treatment in a patient population in real time," PatientsLikeMe co-founder Jamie Heywood said in a statement. "While not a replacement for the gold standard double-blind clinical trial, our platform can provide supplementary data to support effective decision-making in medicine and discovery. Patients win when reliable data is made available, sooner."

The study, also outlined five advantages of using online tools to collect patient-reported data to monitor drug use. These are:

-- Speed. It took only nine months from initiation of the tool (March 2008) to the first public sharing of preliminary results (December 2008).

-- Patient access. There is a potential to rapidly recruit widely dispersed patients with rare conditions and to overcome selection bias favoring patients living near specialist centers.

-- Availability of control participants. Clinical outcome data were passively collected from thousands of patients who served as potential matched controls.

-- Cost. Online studies have lower marginal costs per patient as compared with thousands of dollars per patient in traditional trials.

-- Patient engagement. Patients who submitted data using the PatientsLikeMe website were connected with other patients, which may have a range of benefits.

PatientsLikeMe, a health data-sharing website with more than 100,000 patients and 500+ conditions, presented the study's preliminary results to the International ALS/MND Symposium.