Non-Interventional Studies (NIS) are the essential part of the clinical development program of new pharmaceutics. Within non-interventional trials patients are treated under the real life conditions to investigate the effectiveness of the particular drug. Non-interventional trials include:
- post-marketing surveillance studies (PMS)
- post authorization safety studies (PASS)
- cohort studies
- case-control studies
- register studies
NIS are the studies where the medical products are prescribed in the usual manner in accordance with the terms of the marketing authorization. Key points of patients’ assignment criteria and type of prescription of the medicine – are these factors affects a particular therapeutic strategy? Which monitoring procedures and epidemiological methods should be used for the analysis of collected data? What are the key regulatory questions and success factors for NIS conduction in Russia, EEU and CIS?