Aetion launches SURF screening tool to determine suitability of using real-world evidence to support effectiveness claims in FDA regulatory applications
Details of the SURF screening tool, developed by Aetion, has been published in the peer reviewed journal Clinical Pharmacology & Therapeutics.
Global leader in real-world evidence (RWE) technology and analytics Aetion has developed a screening tool, denoted with the acronym SURF, to assist sponsors in assessing the feasibility of using real-world data (RWD) to provide evidence supporting an effectiveness claim in US FDA product applications. Details and background information on the tool have been validated in a peer-reviewed, open access article entitled ‘SURF: a Screening tool to evaluate whether Using real-world data to support an effectiveness claim in an FDA application has Regulatory Feasibility’, recently published in the journal Clinical Pharmacology & Therapeutics.
Ulka Campbell, Head of Scientific Strategy at Aetion, commented directly to The Evidence Base:
“As FDA advances its RWE program, biopharma innovators must be prepared to anticipate and meet evolving requirements for evidence to support a medicinal product approval. Given the considerable resources required to establish a robust real-world study design and fit-for-purpose data, and being that clinical development resources are often limited, sponsors should assess whether their clinical development program is a good candidate for RWE use in the first place.”
Campbell continued “The SURF screening tool — built on our analysis of guidance, RWE uses in Agency approvals, and years of experience — provides a method by which sponsors can evaluate whether an RWE approach for demonstrating claims of effectiveness is worth prioritizing.”
Watch for our webinar with speakers from Aetion to learn more about the SURF screening tool.
The FDA has made considerable progress in advancing its RWE program in over the past few years, issuing a sequential series of draft guidance publications and updates, with the most recent in August 2023. From reviewing the guidance, FDA approvals and their own experience, Aetion identified several key learnings on when RWE is most likely to successfully support an approval and, equally important, when it is unlikely to be successful. They decided to create a tool to help biopharma companies assess their portfolios and determine whether an RWE approach is worth pursuing, given the considerable time and cost associated with assessing study design and data feasibility.
“We have seen sponsors struggling with decisions about whether to conduct an external control arm (ECA), and in publicly available use cases, we have seen many ECAs disregarded by FDA. We applied these learnings to create SURF, which intends to provide sponsors with straightforward and actionable guidance around the use of RWE for effectiveness claims,” said Nicolle Gatto, Chief Science Officer at Aetion. “This actionable guidance can help sponsors distinguish early on between clinical development programs that are good candidates for RWE use from those that are not, and prioritize resources accordingly.”
The SURF screening tool consists of six questions, as detailed in Figure 1 and Table 3 of the publication, that ask about the characteristics of a clinical development program and collectively represent circumstances in which an RWE approach for providing evidence of effectiveness in an application may be acceptable. The SURF publication details that sponsors may be able to most successfully use RWE when randomized controlled trials are not feasible, and the unmet medical need represents an urgent public health issue.
SURF adds to a set of resources that Aetion scientists have developed to support the successful use of RWE in regulatory applications. Whilst Aetion considers the principles of SURF are generally applicable to the European Medicines Agency (EMA), Aetion plan to conduct a similar analysis of European Union legislation and EMA guidance to augment the tool.