Friday, June 18

Leveraging real-world data in cross-sector partnerships is key to advancing clinical development

As the world begins to see a light at the end of the COVID-19 tunnel, healthcare leaders have begun strategizing on how to take the lessons learned and apply them to a post-pandemic environment.

“What we really want to be able to do is leverage many of those learnings that we garnered from this experience and really institutionalize those in the health system as we move forward, and how we reimagine clinical discovery, clinical development and even commercialization of drug therapies as much more of an ecosystem in our world today,” Christopher Boone, VP and global head of health economics and research outcomes at Abbvie, said yesterday at HIMSS’ Accelerate Health event.

As someone with an extensive background in clinical drug research and development, the expanding use of real-world data was top of mind for Boone’s keynote presentation.

This kind of data is any information gathered outside of the clinical trial setting and used across the life cycle of drug development. It’s used to determine the feasibility of clinical trials, to recruit participants, to inform regulatory safety decisions, to lead commercialization and customer support programs, and more.

“It’s just not optimal to conduct a formal randomized clinical trial for a population that is so small, so we rely heavily on the use of real-world data and real-world evidence to really understand the benefits and risks of all drug therapies,” he said.

Within recent history, the use of real-world evidence has been broadly pushed forward, from regulations like the 21st Century CURES Act to advancements in the availability and analytical capabilities of that data.

But this progress alone isn’t enough to generate the type of change desperately needed in the healthcare system today, according to Boone.

He cited statistics in the clinical trial space that exemplify its lacking diversity and efficiency. For example, between 1997 and 2014, the number of ethnic minorities in clinical trials increased only slightly (about 7%), according to Nature.

What’s more, it takes an average of 12 years and costs about $2.6 billion to develop a drug from start to finish, according to Alzheimer’s & Dementia.

For Boone, the future lies in moving away from using big data solely in the context of patient care to seeing how it can be used to understand the quality, safety and effectiveness of therapies in a real-world context. To do this, the often siloed sectors of the industry will need to form new models of collaboration, he said.

“I think that, as we start to really embark on this journey of what does it mean to really improve the patient experience [and] what does it really mean to advance precision health, we have to think about it in terms of what does it look like from a cross-sector partnership perspective, and what are some of the more effective ways to ensure that all parties are getting what they need.”

For that hope to become a reality, healthcare stakeholders need to take three strategic steps, according to Boone.

  • Establish a shared vision and agenda for clinical practice and development focused on the issues of all communities, especially those facing health disparities.
  • Develop a joint plan of action that addresses systemic racism, inequalities, social determinants and diversity.
  • Invest in foundational data analytic capabilities such as curation, tagging, linking and searching to allow for public health surveillance.

“We have to find ways to better understand the needs of each other to better foster a world of trust and transparency in hopes that we can really build this learning healthcare system of more cross-sector partnerships that will enable better science, better clinical care. … Ultimately what we hope is faster, and better, and cheaper clinical discovery and development efforts of drug therapies,” he said.

“I’m very confident that we can get to that place. I’m very confident that we can integrate this philosophy, and these changes, and this game plan. I’m hopeful that we will get there sooner rather than later.”


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