Real World Data - New Frontiers and Current Use-Cases for it´s Collection in the Context of Clinical Studies

Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment options at the time of regulatory approval in Europe and the USA. Comparative evidence generation is even sparser for medical devices. Use of non-randomised studies for the evaluation of clinical benefit in the post-marketing period should be limited to instances when the magnitude of effect is deemed to be large or when it is possible to reasonably infer the comparative benefits or risks in settings, in which doing a randomised trial is not feasible.

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