performed based on systematic reviews of experimental and observational studies, also using Bayesian methods.
Applications of clinical analysis
- Providing full, credible data on the therapeutic effect of the considered health technology and alternative technologies;
- Determining a population which would benefit most from the use of the given health technology;
- Providing detailed information on safety based on experimental and observational data;
- Starting point to further analyses included in the HTA report.
Within the clinical analysis the efficacy and safety of the health technology under consideration in a given indication is determined in relation to alternative therapeutic options. It is developed based on scientific publications characterised by highest quality, identified during a systematic review of medical literature.
Related analysis and services
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- Systematic search
- Meta-analysis and statistical support
- Indirect comparisons
- Quality assessment of evidence
- Manuscript writing and poster preparation
- Marketing materials
Systematic search
For our customers we offer to perform full systematic reviews fulfilling all international requirements. The scope of this service is always tailored to the clients’ needs and may include:
- Definition of health problem according to PICO(S) scheme,
- Definition of criteria for inclusion/exclusion based on PICO(S) scheme,
- Designing search strategies of maximized sensitivity and specificity,
- Searching of international medical/economic databases (PubMed, EMBASE, Cochrane’s CENTRAL, Web of Knowledge, Econlib, etc.)
- Searching ofregional databases including databases from Asia-Pacific countries (CqVip, IndMed, KoreaMed, ICHUSHI-Web, Wanfang, PakMediNet)
- Full process of study selection based on prespecified criteria appropriately reported and illustrated on PRISMA diagram.
Meta-analysis and statistical support
For our clients we offer a comprehensive support and consultancy regarding appropriate data processing and representation. This may include extraction of relevant information from clinical trials and thorough analysis of heterogeneity followed by aggregation with appropriate method of meta-analysis.
Heterogeneous data significantly hamper the inference and diminish quality of the analysis. Therefore, we facilitate our customer investigating the reasons of heterogeneity using variety of statistical methods including subgroup meta-analyses or regression models.
On the customer’s request, the results of each analysis can be illustrated with high quality plots or graphs, such as forest-plots, bubble-plots, funnel-plots, etc.
Quality assessment of evidence
Our experts may provide a complex evaluation of methodological credibility of provided evidence or analyses in order to ensure our customers that the evidence which support their activities is of high methodological quality and free from potential biases. Our services may include:
- thorough assessment of credibility of published studies including evaluation of the risk of biases,
- full evaluation of data accuracy in types of analyses presenting clinical outcomes, including verification of:
- systematic search and trials selection,
- data extraction,
- methods and accuracy of data aggregation (e.g.: in meta-analysis),
- inference based on available evidence in accordance with standards of evidence-based medicine
Indirect comparisons
Often, head-to-head trials available in public domain do not allow to compare the intervention of interest with all relevant technologies. However, despite the lack of studies directly comparing intervention A with B, their effects can be statistically compared using methods of indirect comparison.
Depending on the number of technologies to compare and availability of clinical data indirect comparison may involve:
- method proposed by Bucher used for comparison of one intervention with one comparator through a common reference technology
- sophisticated network meta-analyses using Bayesian of frequentist methods allowing for simultaneous comparison of several technologies.
Manuscript writing and poster preparation
Well written manuscripts together with appropriate data visualization and accurate discussion of the results increase the chance for acceptance the publication in reputable peer-reviewed journals. HTA Consulting has established experience in leading the customers through the entire process of publication. Our services include:
- Manuscript writing,
- Preparation of high-quality figures and tables,
- Support of the selection of appropriate journal based on Journal reputability (e.g.: impact factor), profile, access policy, payments.
- Submission of the manuscript with cover letter preparation,
- Response to the editors’ and reviewers’ questions,
- Re-submission strategy in case of rejection of the manuscript.