In July, delegates from Rho, Shann Williams, David Cass, and Ryan Bailey, attended the 2nd Annual Strategies in Patient Centered Clinical Research conference in Boston.  They share their thoughts on the conference below.

Patient centricity is garnering broad attention in our industry, but finding time to thoroughly explore the principles and practices of the movement can be difficult.  Needless to say, we were excited to spend two full days immersed in discussion and collaboration with some of the industry pioneers in patient-centered clinical research.  Condensing all of the great content into a few paragraphs is impossible, but we wanted to share our take on the main themes and trends that stood out to us from the event.

A Rapidly Evolving Movement

We are excited to see the patient centricity movement evolving and growing before our eyes.  We were fortunate to attend the inaugural conference in 2016, and the change from last year to this year was noteworthy.  Last year, much of the focus was on establishing the rationale for patient centricity, and convincing stakeholders that patient engagement was worthwhile.  This year, the presentations were much more focused on action and implementation.  The “why” and “what if” questions continued to permeate our conversations, but it’s encouraging to see that we’re not letting some uncertainty hinder progress.

Integrated Patient Engagement Specialists

Many companies are prioritizing patient centricity by creating new positions and departments solely dedicated to patient engagement.  More importantly, these new patient engagement leaders are not merely figureheads, but integral corporate leaders with the authority to enact change at the business unit and study level.  Several presenters shared how their patient engagement teams are integrated into their R&D, study design, and protocol development efforts throughout the product lifecycle.  One presenter noted that, “every project coming to our protocol review committee will be asked if they considered patient insights when designing the trial.”

New Tools and Processes

With companies appointing patient-focused leaders and new departments, it is not surprising that many companies are now developing processes and tools to support better patient integration. The evolution of tools and procedural documentation provide a much needed structure and framework for moving patient centricity from concept to practice.
A sample of the tools mentioned:

• Protocol Quality Assessment Tool with a patient engagement component
• Patient Engagement Toolkit for Study Development
• Unique Patient Plans for each therapeutic area
• Redesigned Informed Consent Forms using professional designers and user interface experts
• Simulation Labs to test drive the protocol with staff and patients before a trial launches

Technology is a Tool, Not a Panacea

Several presenters discussed using emerging technologies to improve trials – e.g., using Uber and Lyft for transporting patients to visits, employing social media listening to determine patient needs, creating virtual, on-demand sites to conduct visits – but a prevailing theme was that technology alone will not achieve patient centricity.  One presenter lamented that in the past 35 years, pharmaceutical development has made no gains in time-to-approval or rate of approval, but cost has gone up an average of $3.0 billion.  Despite all the technological advances in the past three decades, none of the key performance indicators of our industry have improved.  We should leverage technology in our continuous improvement efforts, but not at the expense of investing in other strategies – like patient engagement – to reduce cost and time, and improve success rates.

Metrics and Measurement

Yes, the dreaded “M” word.  From the outset, patient centricity has been hampered by a lack of data quantifying its benefit to trials.  Common sense arguments in favor of patient engagement – e.g., improved recruitment and retention, improved adherence, fewer protocol amendments – have propelled the movement, but the desire for metrics has not dwindled.  Capturing metrics takes time, and it can be difficult to determine the value of a set of broad and somewhat nebulous patient engagement strategies, but some groups are making headway.  Several presenters shared data reinforcing the value of patient centricity.

Highlights:

• Internal review at a top-10 (annual revenue) Pharma company found that 26% of their protocol amendments were attributable to participant burden.  Another top-10 Pharma company reported seeing a year-over-year decrease in the number of protocol amendments after implementing patient-centered strategies.
• Research between DIA and the Tufts Center for the Study of Drug Development found that the single strategy of engaging Patient Advocacy Groups in trial design, added 2-4 months of additional up front planning time, but ultimately saved millions of dollars in prevented protocol amendments and led to faster FDA approval.
• Research out of the Clinical Trials Transformation Initiative (CTTI) found that improving the patient experience (e.g., user friendly informed consent, simpler eligibility criteria, reduced patient burden) could save 10s of millions of dollars in Phase II and Phase III trials.

Summary

For an industry that is often criticized for moving too slowly and resisting change, it is inspiring to see the evolution in just one year’s time.  As companies move beyond concept and into implementation, we are eager to see how these changes will impact patients and improve our research.

One of the quotes that stood out to us from the conference is “the biggest tragedy in clinical research is not a failed trial, it is a successful trial that fails in the real world because we didn’t design with the patient in mind.”  This serves as a poignant reminder that our work must be fundamentally focused on healing patients, not merely getting approval or getting to market, if we are to make a positive impact.