Subjects no more: what happens when trial participants realize they hold the power?
BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g368 (Published 28 January 2014) Cite this as: BMJ 2014;348:g368- Paul Wicks, vice president of innovation,
- Timothy Vaughan, director of data science,
- James Heywood, cofounder and chairman
- 1 PatientsLikeMe, Cambridge, MA 02141, USA
- Correspondence to: P Wicks pwicks{at}patientslikeme.com
The social contract of the randomized controlled trial is imbalanced: patients adhere to arduous protocols, are randomized to placebo, and are blinded to their health status. Although most participants (>90%) would like a lay summary of results,1 only a minority (<10%) receive one,2 with the remainder left with the option of paying around $30 (£18; €22) to read the results once the study is published in a peer reviewed journal.3 Such imbalances may have contributed to an emerging movement, enabled online by “patient powered research networks,”4 in which participants have begun systematically to unblind themselves, pool their data, parse literature, conduct statistical analyses, and post their findings online.
In 2007, patients with amyotrophic lateral sclerosis (ALS) used Google to translate an Italian conference abstract suggesting that lithium carbonate might slow their illness.5 In a publication titled “Lithium delays progression of ALS” 16 patients treated with lithium (all of whom survived 15 months) were compared with 28 control patients (a third of whom did not survive the trial).6 Within six months of the abstract’s publication 160 patients reported obtaining lithium off-label and tracked their progression using Google Spreadsheets and the validated ALS functional rating scale (ALSFRS-R).7 A patient in Brazil and …