PHARMA WANTS MORE REGULATORY ACCEPTANCE OF ELECTRONIC OBSERVATIONAL STUDIES
Sanofi Pasteur hopes real world evidence produced from an observational clinical trial in the US using data from 1.6 million people and in which its Flublok vaccine will be compared with standard-dose inactivated influenza vaccine can promote the cause of using Big Data.
Through its partnership with Kaiser Permanente of Northern California, an integrated healthcare system, Sanofi Pasteur is backing a real-world evidence study of its egg-free, cell-based influenza vaccine using data generated during post-marketing routine clinical practice with Kaiser Permanente’s digitalized patient record system.
“It will allow us to get a better understanding of the performance of vaccines in a real world environment, help demonstrate the value of a vaccine, and provide insights for future vaccines development.” - David Loew, executive vice president of Sanofi Pasteur
David Loew, the head of Sanofi Pasteur, said in an interview that the observational study, which began last September, aims in large part to demonstrate the power that integrated electronic health registries can have on vaccine evaluations.
“It will allow us to get a better understanding of the performance of vaccines in a real world environment, help demonstrate the value of a vaccine, and provide insights for future vaccines development,” Loew said during a recent visit to London.
The study’s overall objective is to describe the effectiveness of Flublok Quadrivalent vaccine compared with standard dose inactivated influenza vaccine (SD-IIV) in adults 18 to 64 years of age.
The 2018-2019 and 2019-2020 formulations of Flublok Quadrivalent recombinant influenza vaccine and SD-IIV will be evaluated for outcomes including all polymerase chain reaction (PCR)-confirmed influenza, PCR-confirmed hospitalized influenza, hospitalized community-acquired pneumonia and cardio-respiratory events.
Loew said that because the study was conducted by Kaiser Permanente in a routine clinical setting, and due to the controlled nature of the vaccination logistics and the depth of their electronic medical record system, the collection of data would be highly efficient in terms of patient vaccination, identifying influenza events and flu-related complications in outpatient and inpatient facilities.
It may also reduce bias in the analysis.
“This might be something that’s really going to change the future of running clinical studies, because having electronic medical records allows you to compare very large sets of data,” Loew said. “This real world data setting will allow us to tease out new findings as well.”
Loew continued: “Some healthcare systems cannot pick up, for example the correlation between the flu and a cardiovascular event, because they make the wrong diagnosis; they think it’s the flu and they try to treat it as if it is the flu but when you are later hospitalized and you have a cardiac arrest, they don’t link that scenario. There is increasing evidence where we see a correlation between the two.”
He added, “This is a really new model that we’re pushing here. These observational studies will allow records to electronically map people from their first vaccination on to when a health issue becomes apparent.”
Loew said observational studies like this were opening up an entirely new field of scientific analysis. “And regulators are following this very closely, because if it proves to be a viable model it would allow data for many more people, and done at a fraction of the cost.”
The research has wide applicability. “We’re working now with governments to see where else we can do these studies in the future,” Loew said.
“The countries that are best prepared with electronic medical records are going to be able to get involved.”