Do we need real world data? Polish ISPOR Chapter Therapeutic Programs, Pharmaceutical Care and Pharmaceutical Law Section (TPPCPL) initial discussion

Abstract

Objective: to discuss potential areas for use and sources of real world data in relation to medical treatment. Methods: we performed Pub-Med and an internet based search in literature for definitions, sources and examples of real world data use. Results: we identified 13 publications fitting our search criteria and we found that there are not many full publications related to real world data even if they can provide significant additional information regarding patient related outcomes, resources use, costs and the effect of therapies in a non-controlled environment and on broader populations than those from randomized clinical trials. Conclusion: Real world data can provide additional information in relation to medical treatments however there is a need to focus attention on methodology of data collection, data quality, potential sources of data and ensure proper legal environment for data collection. Unfortunately, despite large number of publications identified in PubMed database, there are only few available in a form of full text papers, the majority of publications are only abstracts from scientific conferences. In the future in order to share RWD experience it will be of benefit to encourage authors to work on full publications and not to limit their work only to abstracts.