The explosion of online communities and crowdsourcing has shifted discrete internal corporate functions externally to an anonymous network of motivated individuals. This change has had a significant impact on product development and marketing practices, in an effort to increase the connection of a customer to a brand, ensure long-term loyalty, and in turn, increase sales.
This concept of “customer knows best” is also starting to edge into the space of clinical research. Indeed, it was the focus of the plenary session at the Partnerships in Clinical Trials conference in Las Vegas, Nevada last month. Keynote speaker Roni Zeiger, MD of Smart Patients certainly made a good case for the involvement of a network of “microexperts” in protocol development and establishment of endpoints and outcomes relevant to patients living with the studied disease. Shortly following this conference, PatientsLikeMe announced a five-year agreement with Genentech, to explore use of their global online patient network to develop innovative ways of researching patients’ real-world experience with disease and treatment in oncology.1
So what about this swing from physician to patient as “research expert”? Do you want the people in line at your local Starbucks to be deciding key outcomes for complex research protocols? The answer is certainly not simple, and for the purposes of this piece I will focus on the positive aspects of this trending topic.
In many cases, especially life-altering or end-stage diseases, the importance of quality of life (QoL) evaluations cannot be overstated. Crowdsourcing input from patient groups to determine the type and frequency with which these measures are taken in a research protocol should provide the most accurate indicator of the patient experience. The utility of this type of exercise was seen with the FDA approval of a Phase II study assessing the utility of the antihypertensive drug lisinopril as adjunctive therapy in multiple sclerosis.2 The protocol was designed by Transparency Life Sciences whose platform allows patients, physicians, researchers and other stakeholders to contribute to the design of clinical studies.3 A novel efficacy parameter was suggested by participating patients, exemplifying the unique perspective this group provides.
A further benefit for clinical trial recruitment is also possible with the crowdsourcing of research protocols. A trial designed with the input of patients living with the disease should align with “real-life” and by capitalizing on the motivated patients within the existing online communities, the trials themselves should benefit from expedited recruitment and sustained retention. Given that recruitment is the single largest driver of clinical trial costs, this will surely be a benefit to companies conducting clinical trials.4
There is certainly resistance to this concept, but as pharmaceutical companies face mounting pressure for increased transparency, capitalizing on the crowdsourcing movement is a great step forward.