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



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


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

“What we really want to be able to do is take a lot of that learning that we have gained from this experience and really institutionalize it in the healthcare system as we move forward, and how to reimagine clinical discovery, clinical development and even commercialization of drug therapies, as much more than an ecosystem in our world today, ”Christopher Boone, vice president and global director of health economics and research results at Abbvie, said yesterday at the HIMSS Accelerate Health event.

As a person with extensive experience in clinical drug research and development, the increasing use of real-world data came first for the presentation of Boone’s speech.

This type of data is any information collected outside the context of the clinical trial and used during the life cycle of drug development. It is used to determine the feasibility of clinical trials, to recruit participants, to inform safety regulatory decisions, to guide marketing and customer service programs, and more.

“It is simply not optimal to conduct a formal randomized clinical trial for such a small population, so we rely heavily on using real-world data and real-world evidence to truly understand the benefits and risks of all drug therapies.” , said. said. said.

In recent history, the use of real-world evidence has been boosted greatly, from regulations like the CURES Act of the 21st century to advancements in the availability and analytical capabilities of that data.

But this advance alone is not enough to generate the kind of change that is desperately needed in today’s healthcare system, according to Boone.

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

Also, according to Alzheimer’s disease and dementia, it takes an average of 12 years and costs about $ 2.6 billion to develop a drug from start to finish.

For Boone, the future lies in stopping using big data solely in the context of patient care to see how it can be used to understand the quality, safety, and efficacy of therapies in a real-world context. To do this, often isolated industry sectors will have to form new models of collaboration, he said.

“I think when we really start to embark on this journey, what does it really mean to improve the patient experience? what it really means to promote precision health, we need to think in terms of what it looks like from a cross-industry partnership perspective and what are some of the most effective ways to ensure that all parties get what they need. ‘

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

“We need to find ways to better understand the needs of others to better foster a world of trust and transparency in the hope that we can really build this health learning system of more cross-sector partnerships that enable better science, better clinical care … Ultimately, what we hope will be faster, better and cheaper efforts in the development of therapies and clinical discoveries, ”he said.

“I am very sure that we can get to that place. I am very confident that we can integrate this philosophy, these changes and this game plan. I hope we arrive as soon as possible. «