Real world evidence studies answer the question frequently asked by payors: ‘How do real patients perform on the medicine?’

This is in contrast to the randomised controlled trials, mandated by the regulatory bodies before a product is granted marketing authorisation, which are designed to answer the question: ‘Does the medicine work?’ 

The next question usually asked is: ‘How much more cost effective is this medicine compared to the ones we already have?’

Real world evidence needs to answer a specific research question.

As with randomised controlled trials, their construction needs to be exposed to the same rigour in their protocol writing, statistical analysis and planning, etc.

Medialis has pioneered the use of :

  • patient registries in measure efficacy

  • safety outcomes

  • patient reported outcome measures.

 

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