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Alexandra Sosinsky, our Director, Pharmacoepidemiology & Safety, offers her thoughts on FDA’s recent guidance regarding the use of real-world data and real-world evidence to support regulatory decision-making.


In late August, FDA released its final Guidance for Industry on Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.

There is continued interest in the utility of real-world data (RWD) to support regulatory decision-making with respect to a product’s effectiveness and safety. When considering the evolving industry guidance and use cases for RWD, the FDA continues to emphasize good research practices and transparency. This includes practices such as:

  • Finalizing the study protocol and statistical analysis plan (SAP) prior to study implementation
  • Protocol registration in a public repository
  • Documenting roles and responsibilities of any third parties involved in study-related work
  • Maintaining audit trails of data
  • Ensuring the availability of patient-level data for submission to FDA as applicable.

Central to the theme of transparency in this guidance is the recommendation to address data source evaluations, including fit-for-purpose assessments and feasibility analyses conducted. Within the study protocol, sponsors should justify the selection or exclusion of specific RWD sources for the research question at hand. Sponsors are expected to prioritize the systematic evaluation of candidate RWD sources and document the conclusion of these evaluations within the study protocol. This will enable discussions of fit-for-purpose data source selection with FDA prior to study implementation.

Genesis Research Group is a data-agnostic organization well-versed in the strengths and limitations of RWD sources across therapeutic areas, having utilized over 40 unique data sources on behalf of clients. We are experienced in the design and implementation of research processes that fully align with regulatory guidance documents.

In the light of the recent FDA guidance, our real-world evidence experts are ready to provide objective scientific leadership on rigorous, systematic fit-for-purpose data assessments.

To ask Allie and her team about our RWE research solutions and the value of our data-agnostic approach, contact


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