Real World Data Part 3: Consider Relevancy

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Relevance and reliability of RWD

In order to determine the suitability of Real World Data (RWD) for regulatory decision-making, the FDA will assess the relevance and reliability of the source and its specific elements. Important factors associated with RWD relevance primarily are: 1) sufficient details ; 2) capability to address specific questions; 3) interpretable using informed clinical/scientific judgement. Reliability of RWD is associated with data accrual and data assurance. Data assurance consists of the quality of data element population, adherence, completeness, consistency and the program evaluation process.

Specifically, when RWE is intended to be used for purposes of evaluating a regulatory question, the following considerations for RWD should be:

  • In order to use RWD, the device must be sufficiently identified with the level of detail necessary to address the regulatory question. For example, to evaluate a particular device, the Unique Device Identifier (UDI) or serial/model number may be necessary to identify the device within a RWD source that contains data on many similar devices;
  • RWD should meet the criteria of relevance and reliability;
  • RWD should be presented to FDA according to recognized data standards (i.e. in standardized file formats and data structures, utilizing standardized variables and definitions, etc.) when applicable.
  • If RWE is derived from multiple RWD sources, each RWD source will be evaluated individually and together in the aggregate to determine the relevance and reliability of the RWD.
  • The methodology used to analyze RWD and assess clinically relevant differences as well as statistical significance should be scientifically robust.

 

To give some examples, the FDA has been using RWD and RWE, derived from the Sentinel System, to eliminate the need for post-market studies on nine potential safety issues involving five products. This makes the FDA’s post-market evaluation of safety timelier and more effective.

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