Updated on: Jan 9 2014

Methodology and Clinical Validation

Methodology and Clinical Validation: from the bench to the clinic


Recent improvements in technology are leading to an improved understanding of the molecular and cellular events involved in the development of MM. However, translation of such knowledge into clinical practice requires the establishment of a multidisciplinary network as proposed. However, there is no organized structure for a translational process that ensures an integration of new biological data into clinical decision-making.

In order to achieve this it is essential to initiate a programme of clinical validation and standardization of diagnostic and prognostic tests and the treatment programmes of different European countries. Implementation of potential new assays will be focused and accelerated moving rapidly from the laboratory bench to the clinic.

Preview Programme Proposal

In general new diagnostic or prognostic tests have to pass different stages before they are successfully validated. Analogous to therapeutic trials four different phases (phase 1-4) are believed to be necessary for the clinical validation of new laboratory tests.

In the first phase, a technique is established in the laboratory and analysed for specificity, sensitivity, reproducibility and accuracy. The second phase documents the likely clinical influence in single centres analysing retrospective material/data. The third phase prepares convincing single centre prospective evaluation evolving into the most important phase four, a multi centre prospective evaluation based upon important clinical end-points.

Ideally, phases 2-3 document the usefulness of an assay convincing one or more centres to participate in prospective phase 4-validation trial. However, in most cases phase 4 studies have never been performed but will be the goal for this proposal by;

  • carrying out a Phase 2-3 validation of diagnostic or prognostic "tests" by clinical end points based on the "EMN Biobank" and "Clinical Databases"
  • initiating a prospective phase 4 validation of new "tests" based on recent improvements in genomic, proteomic and cytomic technologies.

Deliverables and Cooperations
The development of evidence-based guidelines for good clinical practice will benefit from such streamlined strategies and these guidelines will be the backbone of clinical trials focussing on improving myeloma patient care.

Secr. Hans E. Johnsen | Depart. of Haematology | Aalborg University Hospital | Sdr. Skovvej 15 | DK-9000 Aalborg | Denmark | T:+45 9766 3871 | F:+45 9766 6369