By Marylyn Donahue.
Crowd sourcing is hardly new, not even for pharma. Pfizer launched the first ever clinical trial to recruit and communicate with patients entirely via the Internet in 2011. Although it did shut down earlier last year due to lack of participants.
But that certainly doesn’t mean crowd sourcing (use of web-based technologies to recruit project participants) is dead.
On the contrary, participatory health in general has emerged as the hot, growing area with individuals using health social networks, crowdsourced studies, smartphone health applications, and personal health records to achieve positive outcomes for a variety of health conditions.
Last month the FDA cleared the drug developer’s Transparency Life Sciences (TLS) IND application to study a generic hypertension drug for a new potential use in patients with multiple sclerosis.
The clearance is the first for a clinical trial protocol developed with the aid of crowdsourcing, and is among the first to make intensive use of telemonitoring and other remote methods for patient data collection.
“FDA clearance of our first crowd-sourced protocol is a major milestone in our efforts to build a drug development company for the twenty-first century,” Tomasz Sablinski, MD, PhD, founder and CEO of TLS told Centerwatch.
A key element of TLS’s approach is incorporating insights gathered from a global crowd into its clinical protocols using the company’s Internet-based Protocol Builder, an online tool that elicits input from patients, physicians and researchers to help design clinical trials more efficiently and with greater relevance to clinical practice and patients’ needs.
So why is it all coming together now?
“Crowd-sourced health research studies is the nexus of three contemporary trends,” says Melanie Swan in her recent paper “Crowd-sourced Health Research Studies: An Important Emerging Complement to Clinical Trials in the Public Health Research Ecosystem,” published in the Journal of Medical Internet Research.
• Citizen science (non-professionally trained individuals conducting science-related activities);
• Crowdsourcing (use of web-based technologies to recruit project participants);
• Medicine 2.0 / health 2.0 (active participation of individuals in their health care particularly using web 2.0 technologies.
She points out that patient groups such a PatientsLikeMe and 23andMe have emerged as the leading operators of researcher-organized, crowdsourced health research studies.
“Crowd-sourced health research studies have arisen as a natural extension of the activities of health social networks (online health interest communities), and can be researcher-organized or participant-organized,” says Swan who sees participatory health initiatives as having the potential to facilitate a next-generation understanding of disease and drug response.
“Not only is the large size of crowd-sourced cohorts an asset to medical discovery, too is the near-immediate speed at which medical findings might be tested and applied,” says Swann. “Participatory health initiatives are expanding the scope of medicine from a traditional focus on disease cure to a personalized preventive approach.”
Oh, and remember Pfizer’s failed virtual trial mentioned earlier (for recruiting and managing online participants with overactive bladders)? Well, the drug company is not giving up. They plan on re-jigging the model and it could be re-launched later this year.
Pfizer’s Craig Lipset was quoted recently as saying that with a few “internal alterations” and some changes to fit with the European regulators need, Pfizer will try again soon, this time in the EU.