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The Food and Drug Administration (FDA) defines Real World Evidence as the clinical evidence regarding the usage and potential benefits or risks of a medical product. In other words, Real-world evidence is a strategy to understand medications’ impact and safety better and has its origins in the pharmaceutical industry.
In Tobacco Harm Reduction (THR), Real World Evidence seeks to understand the benefits of harm reduction options such as E-cigarettes and other non-combustible nicotine products. Over the years, there have been studies regarding the potential benefits of switching from combustible tobacco to non-combustible nicotine products. Tobacco smoking data shows that Tobacco kills up to half of its users who don’t quit. However, studies conducted over the years show that switching from a combustible tobacco product to non-combustible nicotine products could reduce harm for adult smokers unable or unwilling to quit.
At the just-ended Global Tobacco & Nicotine Forum (GTNF), a panel session comprising public health experts and medical scientists discussed widely regarding Real World Evidence.
Professor Riccardo Polosa, founder of the Center of Excellence for the Acceleration of Harm Reduction at the University of Catania said Real World Evidence was critical in informing public health decisions governing Tobacco Harm Reduction.
“Real World Evidence was designed to measure impact and safety in real-world conditions well outside the rigid and superficial constraints of randomized control trials. Why are we talking about real-world evidence today? It is simple because the same paradigm applies to tobacco and Nicotine Products. Real-world evidence is all about trying to get the grasp and insights of the benefits or risks of the product derived from the analysis of real-world data,” said Professor Polosa.
He added that data from randomised control trials has also shown that electronic cigarettes are useful tools for smoking cessation and this is supported by real-world Evidence data.
“What does real-world evidence add to this picture? It confirms what has been shown in randomised clinical trials and systematic reviews. Real World evidence is a useful tool to bolster data from randomised control trials. Real World Evidence can also show the impact and add more evidence to things that randomised control trials cannot do and cannot investigate. It allows for long-term tracking of health effects.”
He also said that Real World Evidence has been used to track cigarette consumption, improve quality of life, lung function, and reduce respiratory exacerbation in people already using electronic cigarettes or heated tobacco products.
“By the same token, we have been using Real World Data to assess changes in clinical endpoints that have been measured in people accessing emergency department access in hospitals. We made use of real-world evidence to verify that certain flavours can be useful or not in terms of acceleration quit rats or success rates or behavior changes,” added Professor Polosa.
He also said Real World Evidence also plays an important role in enhancing drug safety and can validate randomised control trial findings of the e-cigarettes in the process, strengthening the evidence base for smoking cessation in the real-world setting.
Dr. Maria Gogova, vice president and chief scientific officer for Altria Client Services said to realize the full potential of Real World Evidence, the world must be grounded in sound science.
“You all know that the Tobacco Landscape in the United States is changing rapidly. We see across multiple data sources a constant decrease in smoking prevalence while the prevalence of E-vapour is increasing. We also see that there is a decrease in smoking while on the other hand, there is an increase use of e-vapour since we know that e-vapour products can be good substitutes for smoking,” said Dr Gogova.
However, if you look at the same data trends by the different kinds of age groups, it shows that the overall population prevalence data are primarily driven by younger age populations especially those who are less than 40. However, adults over 40 continue to smoke and are not adopting e-vapour at the same rate as the younger population.
“It is critically important because those are the individuals with the highest risk of smoking-related diseases and premature deaths. Therefore, understanding the potential reasons behind them is important. Risk perception is associated with tobacco use in general and may also impact switching behaviours.”
She added that understanding the reasons behind the smoking behaviour of different age groups was essential to inform broader tobacco harm reduction strategies. Data from a longitudinal cohort study shows that those who completed the switch to e-vapour had a significant reduction in biomarkers exposure compared to adults who continued to smoke combustible cigarettes which according to Dr Gogova further confirms the harm reduction potential of non-combustible nicotine.
She also said Real World Evidence can inform science-based policies and contribute to and also inform harm reduction strategy and future research questions.
Gem Le, Director of Behavioural and Clinical Sciences at Juul Labs said studying humans especially regarding tobacco harm reduction has its research methodological challenges.
“Studies of humans using real-world evidence show that we can’t control people but we can observe and they can report data to us and that’s the source of real-world data. With that comes a very big bucket of data quality challenges and also in the consistency of how data is collected across different data sources. It can vary widely in terms of completeness, timeliness, and relevance, and oftentimes, they are incomplete as a result,” said Le.
She said many of the data sources were administrative where data was not collected for the sole purpose of addressing Tobacco Reduction Research questions. This, according to Le makes these sources not fit for purpose as they may not contain the relevant clinical endpoints and may have limited follow-up for long-term health.
Meanwhile, Konstantinos Poulas, Associate Professor of Biochemistry in the Department of Pharmacy and Head of the Institute of Research and Innovation said Artificial Intelligence (AI) could be useful in generating real-world evidence regarding Tobacco Harm Reduction.
“Real World Evidence is an important factor to judge what is useful and what is not useful. In my opinion, AI can play a multi-factorial role so we can use it for data collection to understand the different patterns to evaluate the effectiveness of all these products. We can monitor public health issues and we can identify risks and we can use it for personalised interventions,” said Professor Poulos.
He added that there are already mobile phone applications being used by smokers to assist in their quitting or smoking cessation journey. There are also chatbots and virtual coaches used to help smokers quit.
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