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Harmonisation of large-scale, heterogeneous individual participant adverse event data from randomised trials of statin therapy - PubMed

Harmonisation of large-scale, heterogeneous individual participant adverse event data from randomised trials of statin therapy - PubMed

Source :

https://pubmed.ncbi.nlm.nih.gov/35815805/

In this meta-analysis of adverse event data from the large randomised trials of statins, approaches based on common standards for data organisation and classification have provided a resource capable of allowing reliable and rapid evaluation of any previously unknown benefits or hazards of statin th ...



Conclusion: In this meta-analysis of adverse event data from the large randomised trials of statins, approaches based on common standards for data organisation and classification have provided a resource capable of allowing reliable and rapid evaluation of any previously unknown benefits or hazards of statin therapy.

  • July 19, 2022
    Key Points
    • Source: Clinical Trials
    • Conclusion: “In this meta-analysis of adverse event data from the large randomised trials of statins, approaches based on common standards for data organisation and classification have provided a resource capable of allowing reliable and rapid evaluation of any previously unknown benefits or hazards of statin therapy.”
    • Meta-analyses process the information from more granular randomized-controlled trials to identify meaningful impact. The Cholesterol Treatment Trialists’ Collaboration contains data from many large long-term statin trials and is looking at the effects of statin therapy on all adverse events documented in these trials. The current article expands on the strategies used and challenges encountered to capture and organize the data in a systematic fashion.
    • Although the RCTs all addressed similar research questions, the authors faced substantial challenges in data harmonization, which were linked to the magnitude and heterogeneity of the data.
    • During the past 20 years, the harmonization of clinical trial findings and outcomes has received attention. For instance, the Clinical Data Interchange Standards Consortium (CDISC) introduced a new iteration of Study Data Tabulation Mode (SDTM) in 2005 to standardize data tabulation from clinical trials and non-clinical studies. The pharmaceutical industry, academia, and the FDA all utilize this approach.
    • According to the authors, “The system we devised for use in the analysis of adverse events related to statin therapy presents one possible solution to this problem by incorporating methodology based on existing, widely recognised data standards devised by CDISC together with use of the MedDRA [Medical Dictionary for Regulatory Activities] dictionary. The strengths of such a system include the transparency of the methodology which may help facilitate the interpretation and generalisability of the results.”
    • MedDRA is a dictionary that reconciles various event-coding formats employed in the included trials and places them in a single common language. It contains more than 77,000 different terms based on a five-tiered hierarchical structure. This structure ranges from the most granular “Lowest Level Term” to the general “System Organ Class.”
    • One major limitation of the approach is that it is labor intensive and taxed many staff resources. For instance, “self-learning” MedDRA mapping software is unavailable, and mapping gobbled up resources.
    • The authors concluded that their endeavors will not only serve as a means to assess statin therapy but also any other effects of the drug class, as well as being modifiable to other contexts to address the ambit of frequently utilized interventions.