Enabling regulatory approval submissions with external control arms

Real world data

This paid-for advertorial by BC Platforms appeared in DDW Volume 24 – Issue 2, Spring 2023

BC Platforms’ Global Data Partner Network provides patient-level, longitudinal, and geographically diverse real-world data and real-world evidence for use as external control arms in randomised human clinical trials, which can accelerate medicinal product regulatory filings and market access.

In 2018, the US Food and Drug Administration (FDA) introduced a policy for accepting real-world data (RWD) and real-world evidence (RWE) in addition to traditional clinical trial data in new drug applications. Since September 2022, additional FDA submission guidance has further highlighted the importance of RWD and RWE. RWD can be defined as the different types of data relating to patient health status or healthcare delivery outside controlled clinical trials, while RWE is the clinical evidence about the usage and potential benefits or risks of a medical product, derived from RWD analyses.

The recent FDA guidance has included external control arms (ECAs), which can be used as additional patient control groups in randomised clinical trials and in submissions to regulatory authorities. The RWD and RWE used in these ECAs is obtained from existing patient-level information in electronic medical records, laboratory systems, patient outcome questionnaires and other sources.

ECAs are increasing in popularity due to the narrowing of clinical trial patient cohorts to meet exacting patient stratification and statistical methodology audit requirements, as well as the need to address time, financial or ethical risks experienced in some randomised clinical trial control arms. ECAs can also help to address the industry’s need to incorporate and represent more diverse patient data across many therapeutic areas, as recommended in recent draft FDA guidance.

With RWD, fewer patients require direct enrolment in randomised clinical trials. This enables broader patient inclusion and saves a significant amount of time throughout the clinical development process, while facilitating improved access to new drugs in new markets for the global patient population.

Real-word data that satisfies stringent data qualifications for external control arms (ECAs).

BC Platforms has used its technology solution to link its data partner sites in its growing Global Data Partner Network, with over 50 million patient lives that meet both GDPR and HIPAA regulations. This has created the foundational infrastructure and legal pathway to patient-level RWD data with an unprecedented breadth and reach. Data is sourced in a neutral, trusted ‘territory,’ either in a Trusted Collaboration Environment or TCE (for example, in a cloud-specific project) or through permissioned access to a user network facilitating access to drug development organisations.

BC Platforms can provide the required RWD for all standard-of-care data by the geography of interest, without each site having to deal with the regulatory or administrative burden of collecting the information. This includes an extensive reach to diverse, individual patient-level data access in hard-to-navigate markets (Europe, Asia, Middle East, and Africa) and requests for patient or provider re-contact. The data provided can be modelled, scored, or run through AI/ML algorithms immediately upon delivery of data access.

BC Platforms is focused on building the world’s leading analytics platform for healthcare and industry. By enabling the use of RWD as ECAs, it is helping to fulfil this mission, with the potential to ultimately benefit patients and their families worldwide.

Learn more at https://www.bcplatforms.com/solutions/real-world-data

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