Crowdsourced Clinical Studies: A New Paradigm in Health Care?

The Miriam-Webster defines crowdsourcing as: “the practice of obtaining participants, services, ideas, or content by soliciting contributions from a large group of people, especially via the Internet.” Clinical studies using patient recruitment and data collected via crowdsourcing is surely an intriguing concept. It characterizes what Dr. Eric Topol describes as the ‘creative destruction of medicine’, challenging previous tenets of clinical research, which emanate from traditional regulations and accepted scientific dogma. The idea of crowdsourced clinical studies arose out of a natural extension of social media. The prospect of rapidly shared medical information which is derived directly from study subjects recruited via the Internet has driven interest in having patients themselves become the originators, investigators, as well as subjects of clinical investigation. This is an offshoot of patient-centric movements such as Health 2.0 and participatory medicine.
Crowdsourced health care studies may originate from subjects themselves, or from traditional sources (companies, physicians). The study subjects determine the degree of information shared and protected. The study may be independent of a corporate sponsor which might decrease the potential for real or perceived conflict of interest. Study subjects participate in data collection and analysis. They may contribute in part or in whole to the design itself of the study.
PatientsLikeMe has conducted the largest number of crowdsourced health studies to date. It aims to include one million patients with rare diseases by the end of this year. One of the first and best known studies involved a cohort of patients with ALS (Lou Gehrig’s Disease) in which the role of lithium on the effect of disease progression was examined. It was shown to be a negative study (where the drug had no positive effect). However, its design and methods were ultimately shown to reflect high standards of practice. The results were published in a peer review journal. 23andME is a company which collects the genetic makeup (genome) of its members and has utilized this information in crowdsourced studies. Crowdsourcing has afforded them the opportunity to evaluate phenotypes (the characteristic expression of the genome) in relationship to genomes, to more quickly verify or discount previously accepted tenets of genetics and to make new discoveries. In addition, patient-organized studies are being conducted via online communities like Genomera and Quantified Self, which have also published quality studies.
Implications of crowdsourced clinical study data for drug and medical device companies and therapies are significant. One may only imagine expedited discoveries of adverse events, benefits, and genetic markers predictive of effectiveness.
The recruitment in short periods of time of tens of thousands or more of study subjects worldwide with the potential for decreasing investigator and sponsor biases is exciting. Exchange of data real-time via wireless technologies, rapid evaluation of results, and more enthusiastic participation and appreciation for clinical research by the public are also potential benefits of crowdsourced studies. Critics of crowdsourced clinical studies cite lack of traditional regulatory oversight, as well as biases in subject selection and study methods. Certainly there need to be rules of procedure and science governing crowdsourced medical studies. One cannot apply the usual boundaries to these types of studies and it will take forward thinking health care provider and patient advocate leaders to all weigh in on these issues. Though some of these concerns have been addressed on an elementary analytical level, much more evaluation of the process will inevitably be undertaken. I look forward this new paradigm of clinical investigation reflecting the penetration of digital health technologies into all aspects of health care.