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Aetion’s comments to FDA on electronic health records and claims to support regulatory decisions

Lowell Schiller, JD
Chief Legal and Regulatory Officer, Aetion


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Last week, Aetion submitted a letter to FDA commenting on the Agency’s recent draft guidance document: Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.

The Draft Guidance reflects FDA’s commitment to fostering high quality analyses of real-world data (RWD) that can provide evidence for regulatory decisions across the product life cycle, including regulatory review of safety and effectiveness in the context of product approval decisions. Aetion shares this commitment and appreciates the substantial effort that FDA is putting into developing resources that will further it.

The Draft Guidance is a critical next step to advancing FDA’s Real-World Evidence (RWE) Framework and the use of high quality RWE in regulatory decision-making. Greater alignment on principles and best practices, and greater public visibility regarding FDA’s expectations, will enable sponsors and other researchers to approach the analysis of RWD with greater confidence that such efforts will lead to the generation of valuable evidence. Further, integrating transparent, auditable, reproducible, and scientifically valid RWE into regulatory decision-making will facilitate more efficient drug development and enhance understanding of product safety and effectiveness. 

Aetion appreciated the opportunity to comment on the Draft Guidance. Key points in our comment letter include:

  • Implementing the recommendations in the guidance will require substantial care and attention to detail, but we believe these recommendations are generally achievable with the use of currently available best practices, scientific expertise, and technology;
  • We agree with the Draft Guidance’s approach of encouraging the pre-definition of essential elements in protocols and statistical analysis plans;
  • While a software platform can address many of the Draft Guidance’s recommendations, there are some aspects that are dependent on information from the data source, and we encourage FDA to provide recommendations to help sponsors and analytics providers evaluate the level of available information when deciding whether to use a commercially available dataset in a study;
  • It is important to recognize that not every recommendation in the guidance will be feasible or appropriate in all studies, and we are encouraged that the Draft Guidance in many places explicitly acknowledges that recommended approaches may need to be adapted based on the context of the study; and
  • We recommend that the Agency clarify its discussion of data linkage and synthesis in order to maximize its utility to study sponsors and to avoid inadvertently discouraging study designs that may be most appropriate in context.

Please view our full comments here. Feel free to contact us with any questions regarding these comments or other issues related to RWE policy and development.

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