General information
The activity of Clinical Analysis Section focuses on comparative evaluation of clinical effectiveness of two or more different therapeutic options: drugs and other medical procedures. An evaluation of the efficacy and safety is provided with existing criteria in accordance with Evidence Based Medicine, (Evidence Based Medicine - it is a set of rules related to an evaluation of credibility and interpretation of medical evidences. EBM can be used either by doctors, patients or decision - makers in the Health Care System) based on world-wide approved guidance of Cochrane Collaboration (Cochrane Reviewer’s Handbook).
Each report consists of the systematic review (Systematic review – it is a systematic selection of scientific reports in accordance with accepted assumptions and criteria) and the meta-analysis. (Methanalysis – it is statistical connection of results received in two or more numbers of primary clinical trials).
The comparative analyses of clinical effectiveness are prepared in several stages:
Stage I: formulating the problem, preparing the focused clinical questions and the research strategy basing on adequate keywords;
Stage II: searching the most important medical databases, registries of clinical trials and medical internet services for clinical studies, as follows:
• Medline by PubMed,
• Cochrane Library (The Cochrane Database of Systematic Reviews, The Cochrane Controlled Trials Register),
• EmBase,
• NICE (National Institute for Clinical Excellence),
• SBU (Statens beredning för medicinsk utvärdering),
• NCCHTA (The National Coordinating Centre for Health Technology Assessment),
• CCOHTA (The Canadian Coordinating Office for Health Technology Assessment);
Stage III: locating the full-texts of studies which are on approved list of reference materials, their selection and assessment of quality;
Stage IV: analyzing of statistical and clinical significance of effects and their meta-analysis (using a directly or indirectly method of comparison);
(Direct comparison - bases on the primary clinical trials that directly compare the evaluated interventions.)
(Indirect comparison - is made only in case when there are no reliable clinical trials which directly compare chosen medical procedures. It is a comparison of two interventions by common comparator, usually placebo. It is characterized by a lower credibility then direct comparison.)
Stage V: interpretation of the results of comparative analysis and preparation of summary.
Clinical Analysis Section bases on a multi-disciplinary team consisting of physicians, pharmacoeconomists and statisticians.
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