Highlights from the 2014 Patient Centered Clinical Trials Symposium

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Applied Clinical Trials

Eye for Pharma hosted its first Patient Centered Clinical Trials symposium in Boston.

Eye for Pharma hosted its first Patient Centered Clinical Trials symposium in Boston, and attracted a diverse mix of attendees including biopharmaceutical companies, technology partners, non-profit organizations, and patient advocates to discuss Clinical Trial Patient Centricity. The main themes at this year’s conference included patient centric technologies, patient centric measurement metrics, and patient advocacy and study site engagement.

Patient Centric Technologies

Cognizant Technology Solutions demonstrated that gamification platforms have enhanced patient centricity. To elaborate, Cognizant showed a visualization of a simple patient application in the form of a map/journey with red flags as milestones; Cognizant indicated that gamifying the clinical trial experience enables patients to better understand the trial and motivates them to stay in the study.

Thomas Krohn, Director of Eli Lilly’s Open Innovation group, showcased Lilly’s engagement models that empower study teams to design protocols more efficiently with patient centricity in mind.  The virtual system gathers data from multiple sources, such as geography analytics, enrollment and exposure models, patient analytics, and investigator analytics. Krohn emphasized that there is a mandate for study teams to use the digital system to design and plan studies. 


Patient Centric Measurement Metrics

Patient centricity is an emerging model and many emphasized the importance of patient centric measurement metrics in order to evaluate the concept’s effectiveness. “We’re still going to have to look at high level performance metrics to see if this particular paradigm will have an impact on some of the classic performance measures,” said Kenneth Getz, Director of Sponsored Research Programs & Research Associate Professor at Tufts Center for the Study of Drug Development.

Michael Howley, Associate Clinical Professor at Drexel University, spoke about defining quality measurement metrics for patient centric models. Howley demonstrated that there are existing predefined measurement instruments, such as SERVQUAL, Chronic Care Model, and Patient Activation Measure that can assist with measuring patient outcomes in patient centric trials.  Howley suggested that sponsors should monitor patient centricity by seeking information on CRO performance from study sites, and CROs should evaluate patient activation sources with study sites in order to properly measure patient centric outcomes.

Study Site and Patient Advocacy Engagement

A new trend is emerging in clinical research: patient advocacy and study site advocacy groups are becoming more involved with biopharmaceutical sponsors and CROs in order to design better clinical trials. Some biopharmaceutical companies have launched internal departments to actively seek partnerships with study sites, patient advocacy groups and patients in order to design better clinical trials. Sharon Hanlon, Director of Clinical Trial Partnerships at Bristol Meyers Squibb, for example, shared her experiences in developing relationships with study sites for better clinical trial performance. 

“Patient advocates pushed us to be more patient centric; it was not something that we as an industry came up with. It was patients and advocates who demanded transparency and input in trial design,” said Andreas Koester, VP, Clinical Trial Innovation & External Alliances at Janssen  “We had a CEO of one of the largest CROs in our office to discuss how we can better partner to bring more patients into clinical trials. We were at a top pharma company talking about how we can pilot together in creating a shared value relationship,” said Jennifer Byrne, CEO of PMG Research. “We are seeing a tremendous awakening,” added Byrne.