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

Author(s)

Mishinova S1, Gomon J2, Kolbin A3, Strizheletsky VV4, Ivanov I5
1First Pavlov State Medical University of St. Petersburg, Saint-Petersburg, Russia, 2Pavlov Medical University, St.Petersburg, Russia, 3First Pavlov State Medical University of St. Petersburg, Saint-Petersburg, SPE, Russia, 4St. George the Martyr City Hospital, St.Petersburg, Russian Federation, 5St.Petersburg State University, St.Petersburg, Russian Federation

Presentation Documents

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 clinicaltrials.gov 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.

Conference/Value in Health Info

2021-11, ISPOR Europe 2021, Copenhagen, Denmark

Value in Health, Volume 24, Issue 12, S2 (December 2021)

Code

POSC413

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Respiratory-Related Disorders

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