POSC413 A Systematic Review of Real-World Clinical Practice Data in COVID-19: Non-Interventional Studies

ABSTRACT

Objectives: To describe the feasible and the most sought-after designs of non-interventional real-world clinical practice trials that provide evidence for the efficacy and safety of drug administration in the therapy of novel coronavirus infection. Methods: A search strategy for the terms "covid-19" AND "real-life", "covid-19" AND "real-data", "covid-19" AND "real-world" was developed to extract articles published between December 1, 2020, and March 12, 2021, in the literature review databases MEDLINE/PubMed, the Cochrane Database of Systematic Reviews, and the database. Results: The search yielded 137 non-repetitive articles, of which 32 were included in the review. All randomized clinical trials (pragmatic and simplified large ones), studies of the effectiveness of laboratory diagnostic methods, medical triage, social distancing and other sanitary and epidemiological measures to contain the epidemic were excluded from the review. Conclusions: The inconsistency of the results suggests some concerns about the reliability of the data obtained in the framework of RWD. There is a need to analyze RWD with evidence-based medicine tools to obtain a more valid RWD or RWE (Real - world evidence). High-quality, non-randomized RWD studies can enhance the external validity of registration RCTs by complementing them with a broader range of indicators, which is essential in supporting medical and public health decision-making in the COVID-19 pandemic.