Assessing the quality of published randomized control trials for direct acting antivirals (DAAs) in the treatment of Hepatitis C, based on the CONSORT statement
Randomized clinical trials is the most adequate tool to evaluate the safety and effectiveness of new medications. The CONSORT statement aims to improve the quality of published clinical trials as well as their effectiveness. The purpose of this study is to evaluate the quality of all published clinical trials for currently used Directly Acting Antiviral drugs (DAAs) in the treatment of hepatitis C. Methods: PUBMED database was searched for clinical trials in English that included patients
... uded patients randomized to at least two groups and at least one of them being administered at least one of the currently used DAAs. The qualitative assessment was based on the revised CONSORT 2010 statement. The possible difference in the quality of the studies, depending on the Impact Factor (IF) of the journal in which they were published, was also evaluated. Results: Only 19 of the 37 elements of the statement are well described in over 75% of the studies. Of the 91 studies, only 33 (36.2%) covered the CONSORT data at > 75%. Mean compliance is 70,5%, 95%CI: (0,68 -0,72). A statistically significant difference in quality was found in journals with a higher IF, especially in those with IF > 20. Conclusions: The quality of DAAs studies in the treatment of hepatitis C is not optimal. Significant shortcomings have been identified, particularly in the description of the research methodology. It is necessary to optimize the quality of both research design and related publications so that safe and well-balanced conclusions can be drawn for both the efficacy and the safety of the new drugs.