Patient Centricity Goes Global


Applied Clinical Trials

Barbara Lopez Kunz, Global Chief Executive at the Drug Information Association discusses how involvement of patients in healthcare is critical for success.

Patient centricity has been a significant area of interest in regions (i.e., US and EU) where regulators evangelized the concept as a priority in clinical trials, and the industry followed suit. Now, the concept of patient-centricity is gaining ground in different global regions. Barbara Lopez Kunz, Global Chief Executive at the Drug Information Association (DIA), works with the board of directors and advisory councils who are experts across the healthcare continuum, and leads DIA’s activities worldwide as they have offices around the world, in China, Japan, India, Europe, and the United States, supporting the Americas, Europe, MiddleEast, Africa, and Asia. In this interview, Barbara discusses how patient-centricity is gaining ground globally.

Can you discuss the idea of a universal patient experience and the guiding principle for it that can be implemented and tailored to respective country expectations, norms, and regulations? 

Barbara Lopez Kunz:The world is seeing that the involvement of patients in healthcare is critical for success but just as important to introduce minimal disruption to their life. For example, the traditional way of

Barbara Lopez Kunz

conducting clinical trials would have a patient turn up at a healthcare facility. Now, ensuring trials are accessible to patients locally is critical to engaging them in healthcare product development. This approach benefits many during the product development process: the sponsor of the medical product, protocol procedures, therapeutic product development, and the patient community at large. In addition, we believe patients need to be involved in therapeutic product development from the early stages. This includes everything from designing the clinical protocol to determining appropriate endpoints and indicators of therapeutic effectiveness. This kind of involvement is now supportedby the FDA, as well asthe European Medicines Agency (EMA). Through concrete guidelines, these organizations ensure that the patient voice is brought in for decision making along the way of therapeutic product development.

In the last few years,more countries have embraced the idea that evolution by medical innovation is essential to the country, its citizens and to the GDP. China, for instance, has taken significant steps toward participating in clinical trials on a global scale with other countries and foreign regulatory agencies. To elaborate, China is actively participating in the International Council on Harmonization, which helps countries set a standard set of regulatory policies and takes actions related to their implementation. We have also seen a significant evolution of entrepreneurs in China. Large multi-national companies, as well as the government, have invested in research dollars in the country, stimulating innovation in healthcare products intended to be available to people outside of China. The healthcare delivery system is also improving as mechanisms for clinical trial design, and execution requests are taking hold. However, it is at an early stage, andthere is muchopportunity for capacity building, learning and collaborating outside of China to ensure that best practices are putin place. 

What are some key challenges the pharmaceutical industry is experiencing when it comes to bridging the gap between pharma companies, patients, and clinical trial participants?

Long before the topic of patient centricity became important, DIA was bringing patients into discussions to help them understand the functioning of regulations and R&D so that they could participate more fully in the process. The organization has been involvedin integrating patients into therapeutic development for around 15 years.We are now at the stage where patients serve as experts on our panels and are writing publications in our journals. In the spirit of patient centricity, some of the areas of opportunity we’ve observed include defining the patient landscape for a multitude of internal and external stakeholders during the product development process. This includes helping the industry better understand the relevant patient groups to engage and how to more effectively bring them into discussions so that their priorities are known. 

We’ve also seen that the pharmaceutical industry is quickly developing the need for better information sharing with patient groups. There has been an influx of people joining the industry who have specific jobs that are focused on patient integration. Many of the companies have their mission, policies, and resources being allocated appropriately to drive this cultural support for patient centricity within the organization. In fact, we have some research programs at DIA in collaboration with industry and patient partners. Patients want their voice to be brought in and integrated effectively, so we see a lot more emphasis on generating processes to integrate the patient voice in clinical trials efficiently.

What advancements in patient engagement along the drug development continuum can we expect in 2019?

We anticipate continuing to see new advances using digital technologies to help facilitate patient-reportedoutcomes and the collectionof data that is relevant to the disease. The digitization and sharing of information are critical to the researchers that are involved in driving those new products to the market and the patients.

We are also excited to see progress as the development of systematic approaches to collecting and using meaningful data advances. A few months ago, for example, the FDA issued its first draft guidance-called the Patient-Focused Drug Development Guidance. We think this was really important because it positions patient input to move beyond anecdotal and representing personal views to encouraging the industry to view it as representative of broader patient communities. We seea positive effect on therapeutic developments as patients start forming their communities and building their knowledge resources that can be utilized in early stages by researchers in academia and industry in the same way as using genomic testing or building patient registries of tissue banks.

How are industry associations like DIA helping to advance innovation in patient engagement?

As part of our mission to advance patient centricity in the product development process, DIA architected a number of helpful patient educational tools. For example, we participated in building an educational system called the European Patient Academy for Therapeutic Innovation, or EUPATI, several years ago. We now see patients as a group that isinvolved in therapeutic innovations at every stage. They publish in our journals, participate in trainingand even teach. We are creating much morecontent that helps industry groups and regulators implement best practices in working with patients. This global neutral platform is helping us spread the word on how successes are being manifestedwith other countries and industry participants around the world. 

Secondly, DIA has been embarking on various research projects. We have been executing programs that bring together industry, academia, patient groups, regulators, and stakeholders across the healthcare system. We are researchingthrough different voices to create tools and processes that can be utilized by all those groups across the entire community. We collaborate with many organizations to bring the resources that we have to the table so that we areefficient in utilizing them to advance the drug development process.


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