The US Food and Drug Administration (FDA) has renewed a four-year collaboration agreement between its Oncology Center of Excellence and Syapse, a real-world-data-focused healthcare company.
The collaboration focuses on the evaluation of real-world data (RWD) study designs and methods, which the partners hope will allow for an exploration of the potential uses of RWD in informing regulatory objectives.
The previous partnership focused on real-world health disparities, examining the impact of Covid-19 on cancer patients and the incidence of pneumonitis – non-infectious lung inflammation – in lung cancer patients.
Syapse uses its artificial intelligence (AI)-enhanced data platform Raydar to process large swathes of RWD and organise them into what it calls “critical insights”. This is vital for any company working with RWD, as one of the main difficulties in the field is low-quality, incomplete or difficult-to-access data.
The vast quantity of data gathered in real-world situations means that if it is used correctly it has the potential to expand patient pools for clinical trials, which is particularly valuable in rare disease trials. It is also being used in the UK to improve the representation of diverse populations in clinical trials.
Interest in the use of RWD has grown in recent years, largely driven by the increased prevalence of digitised medical records and helped along by developments in AI and other automated data tools. The UK’s health watchdog Nice published draft guidance on using real-world data in 2022 and the FDA released an update to its 2018 framework in August of this year.
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As centralised databases of RWD grow, so too do the uses. China is leveraging its mass surveillance systems to improve medical device development, and wearable tech is being used by healthcare providers and insurance companies to monitor patients remotely.
Growth in this area is symbiotic – the more data collected, the more uses that can be found, which in turn is likely to increase the number of patients whose data is collected.
This makes the field particularly interesting to healthcare providers, pharmaceutical companies and governmental bodies – and that interest is evidenced in the growth of mentions of 'real-world evidence' in company filings over recent years, as reflected in GlobalData's analytics.
GlobalData is the parent company of Clinical Trials Arena.
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