Planning and evaluation of clinical diagnostic studies

Focus on diagnostic studies

A key focus of ACOMED statistik's services is the conception, planning, and evaluation of clinical diagnostic studies. This includes both formal and content-related aspects.
  • Regarding content-related aspects, for example, the application population as well as the spectrum of those who are ill and those who are not must be adequately represented, which is difficult to achieve in the widely used case-control studies.
  • A statistically valid determination of the sample size must be carried out.
  • The reference standard or comparison method must be appropriately selected and a suitable study design must be conceived.
  • Furthermore, diagnostic studies are susceptible to biases that can lead to an over- or underestimation of diagnostic accuracy.
With ACOMED statistik you have a partner with many years of experience and numerous references at 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, following the adoption of EU Regulation 2017/246, diagnostic studies to determine or demonstrate clinical performance (i.e., diagnostic accuracy) must 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 part contact with us.

STARD statement: Basis for good planning of clinical diagnostic studies

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

Clinical diagnostic studies: More than a 2x2 table

In general, it can be observed that the quality of such analyses, studies, and product evaluations does not meet the standards customary in the evaluation of therapeutic measures in clinical trials conducted by the pharmaceutical industry. The reason for this is likely that the initial focus appears to be solely on creating and analyzing a simple 2x2 table (disease status vs. test result). Consequently, the work involved in testing a diagnostic drug is often, without any critical reflection, entrusted to medical research groups or responsible project managers who are undoubtedly excellent physicians or scientists, but who lack familiarity with the specifics of planning, analyzing, managing biases, and interpreting such studies.
Even if beyond the 2x2 boards ROC curves These analyses must also be carried out carefully, as the clinically relevant area only covers a part of the ROC curves.
Even university statistics institutes – if they find the time – usually have other areas of focus, with a few exceptions.

Therefore, it is strongly recommended, especially for small and medium-sized enterprises in the diagnostics industry without their own statisticians, to involve external expertise when it comes to the planning, execution and evaluation of clinical diagnostic studies.

ACOMED Statistics specializes in clinical diagnostic studies, thus filling this gap. ACOMED Statistics can draw on outstanding experience. Referencesand participation in numerous Publications refer.