Crowd Sourced Health Care Studies: Implications for Pharma

David Lee Scher, MD, FACC, FHRSDigitalhealthconsultants.com

“The most valuable commodity that I know 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 crowdsourcing for 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 articles

23and Me• >100,000 subscribers

Open 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 data collected online and a patient-matching algorithm. Wicks P, Vaughan TE, Massagli MP, Heywood J. Nature Biotechnology 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 I don’t know, I’m not going to answer.”

------Yogi Berra