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Real-world studies

by Bill Row

Bill Ross

How is real-world evidence (RWE) reshaping the way companies think about research strategies and provide data to their stakeholders?

It’s no secret that RWE is becoming more widely accepted as a reliable source of data for life sciences companies and their many stakeholders. It can now be used to fill those gaps that randomised clinical trials (RCTs) have historically left when it comes to providing real-world data about a product in a real-world setting.

In both the EU and the US, we’ve seen a swift uptake in defining how RWE can be used to meet the needs of different stakeholders and to provide a myriad of information, from safety monitoring and drug utilisation studies of marketed products in the EU to routine safety monitoring of marketed products and filling evidentiary gaps for particular rare diseases in the US. Regulatory bodies continue to focus on the development of guidelines for standardised use of RWE, as payer interest also grows in using RWE to support a product’s value story.

While RWE is not a new concept, its ability to influence decision-making across the product life cycle has increased significantly with the greater availability of and access to real-world data (RWD) sources. Because of the dynamic nature of the markets in which life sciences companies operate, new complex research needs will always arise as more data becomes available and technology ushers in new ways to process and use the collected data.

These complexities that exist across the business spectrum, from scientific to operational, regulatory to market access, and patient-based to competitive, need to be accounted for in the development of a successful research and commercialisation plan. It’s within this context that a comprehensive RWE strategy should be developed to support the overall commercial objectives of a product.

How can life sciences companies maximise the use of RWD and learn to incorporate this data into their strategic thinking?

Insights gleaned from RWD captured during, or even as a by-product of clinical care can not only improve the efficiency of the drug development cycle, they can also streamline clinical trial recruitment, support regulatory filings, expand patient access and be used for drug safety surveillance. With the right technology, infrastructure and support, RWD can be collected, stored, analysed and reported, bringing the benefits of RWE to clinical research and commercialisation decision-making. One of the most impactful places that RWD can be used to cut time and costs is in enrolment processes which can consume up to 40% of the clinical trial budget.

Through a protocol feasibility assessment, researchers can use RWD to estimate the size of the available patient population based on the defined inclusion/ exclusion criteria. That criterion can be applied against de-identified patient data from providers’ EHR systems to determine eligible patients by provider, allowing sponsors to focus on sites that serve a population aligned with the protocol criteria. Software can be programmed at those sites to alert physicians to suitable patients within their practices, giving providers the opportunity to easily consent and enrol prospective participants in the trial.

How can life sciences companies stay ahead of the curve in collecting and providing RWE that their stakeholders will look to request?

It is crucial that companies proactively monitor the real-world performance of their products now that the data being collected can support those activities. By identifying what evidence will support regulators’ and payers’ decision- making, companies can develop an evidence generation plan across the product life cycle to leverage outputs and identify any data gaps that may exist.

We’ll start to see prominent companies in the life sciences space shift their focus to using RWD to support new indication approvals, to show broader real- world outcomes for their products, and with the right technology in place, be able to have at their fingertips a plethora of data that can be smartly synthesised and analysed to return targeted stakeholder communications.

Advances like that which we saw in November last year, when the FDA unveiled its own MyStudies app for the collection of real-world data, will continue to drive the use of RWE forward. This app enables developers to advance new ways to access and use data collected directly from patients, with the necessary controls in place to ensure patient privacy.

Bill Row is Divisional Principal of Real-World Evidence Strategy & Analytics at ICON plc

In association with

ICON

9th August 2019

From: PME

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