Focus on diagnostics

Design and analysis clinical diagnostic studies

Focus on diagnostic studies

A main focus of the services of ACOMED statistics concerns the conception, desigbn and analysis of clinical diagnostic studies. Formal and content-related aspects are affected.
  • Concerning content-related aspects, for example, the application population and the spectrum of those who are ill and those who are not ill should be adequately represented, which is difficult to achieve in the widespread case-control studies.
  • A statistically valid determination of the sample size is to be carried out.
  • The reference standard or the comparison method should be selected appropriately and a suitable study design should be designed.
  • Diagnostic studies are also prone to bias, which can result in over or underestimation of diagnostic quality.
With ACOMED statistics you have a partner with many years of experience and numerous references on your side who can support you in the planning and evaluation of diagnostic studies.

Clinical performance evaluation IvD according to EU regulation 2017/746

In the field of in-vitro diagnostics, after the adoption of EU Regulation 2017/746, diagnostic studies to determine or prove clinical performance (ie diagnostic quality) are recommented to be carried out at a higher level than before.

EU Regulation 2017/246 strengthens the importance of clinical diagnostic studies in the sense of clinical performance evaluation.

ACOMED statistics supports you in the planning and analysis of such studies. Take Contact with us.

STARD statement: basis for good planning of clinical diagnostic studies

This is an excellent starting point for the planning, implementation and evaluation of diagnostic studies STARD statement (2015) (Standards for the Reporting of Diagnostic Accuracy Studies). Although intended as a guideline for the publication of diagnostic studies, the checklist included in the STARD statement is also an excellent planning tool.

Clinical Diagnostic Studies: More than a 2x2 table

In general, it can be stated that the quality of such analyzes, studies, and product evaluations is not as up-to-date as it is when evaluating therapeutic measures in clinical studies in the pharmaceutical industry. The reason may be that it initially only seems to be about creating and evaluating a 2x2 table (disease status vs. test result). For this reason, the work for testing a diagnostic agent is often placed in the hands of medical research groups, who are certainly excellent medical professionals, but are not familiar with the specifics of planning, evaluation, dealing with distortions and interpreting such examinations. Even if ROC curves are used in addition to the 2x2 plates, these analyses must also be carried out carefully, as the clinically relevant area only affects part of the ROC curves.
Unless there are exceptions, the university statistics institutes - if they can find time - usually have other focus areas.

Therefore, small and medium-sized companies from the diagnostics industry without their own statisticians are strongly recommended to include external expertise when it comes to the planning, implementation and evaluation of clinical diagnostic studies.

ACOMED statistics specializes in clinical diagnostic studies and thus fills this gap. ACOMED statistics can be excellent references and participation in numerous Publications refer.
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