The officials from the European Medicines Agency (EMA) demand a need for "an adequate statistical method to extract, analyze, and interpret" the Real World Evidence (RWE) before they can translate into credible evidence. The EMA hopes that the RWE might provide opportunities to learn more about the risk and benefits of the drug.
The EMA authors also expect testing and validation to be conducted the same way as any new medication is evaluated with "well-controlled and according to pre-agreed plan.” The EMA believes that this will ensure new analytical methods that are acceptable by the regulators.