Dr. Abernethy first initiates the conversation with a description of how she feels in the midst of the pandemic – a combination of being tired, bored and “ready for all of this to be over.”
Dr. Abernethy mentions that she’s also “fairly hopeful about the things that we’ve learned in the middle of this pandemic and what that’s going to teach [us] about the future.”
Zoe mentions that she’s seen a number of organizations come together to solve the pandemic and there’s been quite a bit of collaboration between providers, drug manufacturers, academia and regulatory bodies.
Dr. Abernethy mentions how the collaboration to the response to COVID has several layers and it’s really a whole life sciences in response.
Mike Doyle introduces the concept of the Evidence Accelerator – a project that involves both the FDA and COTA.
Mike discusses how a collaborative effort between Friends of Cancer Research, the Reagan-Udall Foundation, the Accelerator, and the FDA analyzed the question of hydroxychloroquine and whether or not it was going to be effective against COVID.
Dr. Abernethy discusses some of the questions you try to answer with real world data and how it’s different from what you might see in a more traditional clinical trial.
Dr. Abernethy mentions how real world data are data sets that are collected outside of the traditional clinical trial.
Dr. Abernethy highlights how the FDA has been exploring the role of real world evidence in a number of different ways – mostly compelled by the 21st Century Cures Act.
Dr. Abernethy talks about how real world evidence can help us understand the story of COVID-19, what treatments people are receiving and treatment pattern information.
Real world data can also help answer questions as it relates to vaccines, once those roll out in response to COVID-19.
At FDA, the organization has had a long history of thinking about and working with real world data and real world evidence – one of the primary examples of that include the organization’s Sentinel program (an effort to try and continue to monitor drugs across time after they’ve been approved and look for safety signals).
Dr. Abernethy discusses the Evidence Accelerator and how it helps to supplement current real world data and real world evidence with new data sets and new capabilities.
Zoe Li poses the question “how do we maintain the agility in data collection and data curation while ensuring that we’re also being compliant and still incredibly robust in our analyses”?
Zoe mentions two COVID-19 studies based on real world data how to be retracted from high profile medical journals due to a lack of transparency into the data source.
Dr. Abernethy introduces a concept of “deliberate agility” – an acknowledgement to work fast, but not sloppy.
Dr. Abernethy places a focus on transparency in the data – a “ruthless” transparency that is gained from a shared mechanism amongst all parties involved with a study.
Dr. Abernethy discusses the role of real world data and how it relates to recruitment for clinical trials.
Zoe mentions how there are a lot of lessons learned from this extended disruption with COVID-19 that could inform great design and improve clinical trial designs going forward.
Dr. Abernethy notes two key roles of real world data and how the FDA can shape this story around use cases.
Dr. Abernethy notes that the vaccine is a focus, but the FDA has quite a few layers to their involvement – “…we’re the FDA. So our food supply is a concern for the FDA. And so we’re very involved and thinking about supply chain for food and how do we make sure that we are continuing to monitor for foodborne illness and other concerns? Also when you think about it, this is a time when we’re worried about whether or not our pets can get COVID-19 and whether or not there’s issues within the veterinary space related to COVID-19.”
Mike Doyle discusses the collaboration between COTA, FDA and other entities – “I’ve been proud of the effort of the private sector in joining the public sector to do greater good. You know, one of the things that COTA has done in a small way, has stepped up our analytics capabilities and surveillance capabilities under the leadership of Friends of Cancer Research, the Reagan-Udall Foundation, the Accelerator, and the FDA to work hand in glove, to really look at early evidence to ascertain whether or not some of the experimental treatments and drugs we’re using in the field, were going to be a value.”
During the episode, Dr. Abernethy defines the types of real world data – “Real world data can be retrospective. So data that already existed in some system somewhere, and may be getting cleaned up and ready for use. Or it may be prospective, such as pragmatic clinical trials, where patients are randomized in highly generalizable settings to collect real world data.”