Crowd Sourced Health Care Studies:Implications for PharmaDavid Lee Scher, MD, FACC, FHRSDigitalhealthconsultants.com
“The most valuable commodity that Iknow of is information”. –Gordon Gekko
Definition• “The practice of obtaining participants, services, ideas, or content by soliciting contributions from a large group of people, especially via the Internet.”
Crowdsourced Health Studies• Convergence of three phenomena: – Citizen science – Crowdsourcing – Health 2.0
Areas of Research• Drug response• Disease research• User experience in crowdsourced studies• Genetic association
Why Crowdsourced Studies? Critique of Traditional Studies • Selection bias • Limited geographies • Surrogate end points • Short-term follow-up • Few comparative studies • COIs
Advantages of Crowdsourced Studies• Shortened study time.• Facilitate recruitment of patients with rare diseases over widely dispersed areas.• Easy availability of control patients.• Lower cost.• Patient engagement (peer group interaction).
Critique of Crowdsourced Health Studies• Lack of verification of disease presence, intervention, or reported data accuracy.• ? Capacity of patients to report.• One study: data as good or better than traditional samples*• Study design: protocol, bias, funding• Regulation and oversight (IRB, consent forms)*Behrend TS, Sharek DJ, Meade AW, Wiebe EN. The viability of crowdsourcingfor survey research. Behav Res Methods 2011;43(3):800-813.
Crowdsourced Health Care Studies: Classification • Researcher-organized studies • Participant-organized studies
Researcher-Organized Studies• PatientsLikeMe –Self-reported data –Survey questionnaires – 23andME – Genotyping data – Survey questionnaires
PatientsLikeMe• 125,000 members• 1000+ condition communities• 25 published peer review journal articles23and Me• >100,000 subscribersOpen innovation:• Harvard’s InnoCentive Program. – NIH-funded study of type I DM. – Question divorced from answers.
PatientsLikeMe: ALS Lithium StudyAccelerated clinical discovery using self-reported patient datacollected online and a patient-matching algorithm. Wicks P,Vaughan TE, Massagli MP, Heywood J. NatureBiotechnology 29, 411–414 (2011) doi:10.1038/nbt.1837• Study of effect of Lithium on progression of ALS.• Study drug had no positive effect on disease.• Landmark trial of crowdsourcing technique.
Participant-Organized Studies• Genomics: Genomera, DIY – Genotyping data – Blood test results – Self-reported data – Survey Questionnaires• Self-tracking:Quantified Self, Curetogether – Self-tracking data (sensors) – Self reporting data
Self-Tracking: Curetogether.com• Symptoms• Treatments –Attempted –Efficacy –Adverse events/side effects• Perceived precipitants or causes of disease• Comments, observations
Crowdsourced Health Studies: Applications to Pharma• Post-market efficacy and AE surveillance• Comparative studies• Genomic-phenotype efficacy/safety studies• Medication adherence studies• Marketing efficacy studies
Crowdsourced Health Studies: Applications to Pharma• Improve image of Pharma• Increased patient engagement-> increased adherence• Source of marketing data• Discover genetic/geographic variances in response to meds• Facilitate personalized medicine
“If you ask me a question Idon’t know, I’m not going toanswer.”