Biopharmaceutical companies both big and small have witnessed the shift toward patient-centric practices in the current healthcare landscape. As a result, many are now including or planning to incorporate the voice of the patient in their drug development strategy.
How do clinical research organizations (CROs) respond and support this increasing focus on patient-centric practices? We recently spoke to Jonathan Zung, PhD, group president, clinical development and commercialization services at Covance to understand his view on the patient centricity imperative and how it impacts clinical development activities.
In his past life on the sponsor side, Zung witnessed how sponsors are spending more time talking with patients to better understand the burden of the disease and determine patients' needs in a trial.
"The voice of the patient is becoming the new norm," said Zung. "Before joining Covance, I worked at a biopharmaceutical company where everything we did focused around the patient and how to better serve their needs. There is no doubt that more and more sponsors, especially large to midsize pharma companies, and those targeting rare and undertreated diseases will enhance their focus on the patient."
Now, with his leadership role at Covance, Zung is determining how a CRO can help sponsors improve their connections with patients. "For a CRO, patient centricity is about engaging with patients in a meaningful way throughout the design and execution of a clinical trial," explained Zung. "Patient centricity must be grounded in an engagement approach for the patients - we need to understand what the patient wants and expects before, during and after the trial."
By some industry estimates, anywhere from 20-60% of a clinical development timeline is spent on identifying and recruiting the appropriate patients, with as much as 40% of trial costs going toward patient recruitment. Zung believes that CROs can help address these challenges with better methods to identify, engage and interact with patients.
"If we understand how the patient feels about what is acceptable in a trial, such as the number of study visits required, number of study procedures, how far they are willing to travel for a study and their desired experience," said Zung, "we can inform sponsors on how to best identify and engage the patients."
Covance can now use information from consented LabCorp patients to understand their preferences in a clinical trial, how certain perceptions may affect their participation in a study and to recruit these patients into a suitable trial. "We continue to explore and understand the role of mobile health (mHealth) and see how the use of apps and devices can help patients take more ownership of disease management, capture data as part of a clinical trial so we can support sponsors incorporating these technologies into their studies," explained Zung.
By fully understanding the patient mindset, study design teams can adjust inclusion/exclusion criteria and address patient-specific concerns that influence recruitment, retention and compliance. "Our goal is to lessen the burden on the patient and optimize the protocol to ensure they choose to stay in the study," said Zung.
Education also factors into the drug development process as more patients feel empowered to assume proactive roles in their healthcare choices. In a blinded, Covance-administered survey of rare disease patients, 45% of the respondents said they have actively connected with a patient advocacy group for their particular disease state.
"Advocacy groups play a huge role in patient-centric efforts," said Zung. "Many of these groups help educate the patient, not only around the standard of care, but by pointing them to clinical trials. I believe the influence of these groups will continue to grow to help guide feasibility, recruitment and engagement in trials."
Typically, sponsors develop direct relationships with the advocacy groups, but Zung notes that CROs can also build those relationships and help facilitate discussions. In fact, in a recent case study, Covance helped a sponsor establish a relationship with a network of over 60 global advocacy groups. They used this connection to deploy an online survey to identify significant patient preferences and influence the clinical protocol design.
In today's complex and competitive drug development landscape, sponsors need a strong strategy to connect with their patients. A CRO can help develop these relationships and leverage the patient voice as a differentiator and competitive advantage for recruitment.
While there are many approaches to increase patient-centric efforts, Zung noted, "There is no one approach or one form of engagement that is suitable for all indications or trials. Anything we do to get the input of patients and caregivers has tremendous value in a trial. That's why I think it is very exciting to see how the role and influence of the patient is shaping how we run clinical trials today."
About Jonathan Zung, PhD
As a member of the Covance Global Operating Committee, Dr. Zung is responsible for overseeing early clinical services, Phase II-IV clinical development and market access services. He is a proven R&D leader with more than two decades of biopharmaceutical experience in all phases of drug development. Prior to joining Covance, Dr. Zung was vice president and head of global clinical sciences and operations at UCB, vice president and head of global development operations at Bristol-Myers and had various leadership positions at Pfizer global research and development. He received his doctorate in analytical chemistry from Emory University in Atlanta, Georgia and a bachelor's degree in chemistry from the Florida Institute of Technology in Melbourne, Florida.