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UKCRC Health Research Classification System

Biomarkers and screening

Advice on research activities

The term ‘biomarker’ in general refers to a specific molecule, gene or characteristic from which a physiological process can be identified. Biomarkers are typically coded in one of three research activity groups:

2 Aetiology:   Where markers may be first identified in epidemiology studies or further assessed to determine how the molecule/gene/etc. contribute to the cause, risk or development of disease.

4 Detection and Diagnosis:   Where studies of biomarker discovery and biomarkers screening for the purposes of disease diagnosis or prognosis are usually within 4 Detection and Diagnosis.

5 Treatment Development:   Specifically where markers are used to develop treatments. However if looking at pharmacogenetic studies in pre-clinical settings or model systems, most commonly in pharmacogenetic studies (5.1) it should be classified in 5 Treatment Development. Identification of receptor pathways should be classified in 2 Aetiology.

 

Examples:

  • The initial discovery of BRCA1 gene mutations as potential risk factors for breast cancer in epidemiology studies and would be coded in 2 Aetiology.
  • Characterisation of BRCA1 gene, protein and pathway in cancer would likewise be coded in 2 Aetiology.
  • The pre-clinical development and subsequent clinical application of techniques for screening for BRCA1 mutations to determine diagnosis or prognosis would be coded 4 Detection & Diagnosis.
  • Assessment of BRCA1 expression for pharmacogenetics in drug development would be coded 5.1 Treatment Development – Pharmaceuticals.

 

Main inclusion criteria

Testing and evaluation of markers and technologies in humans for use in detection, diagnosis, prediction, prognosis and monitoring in clinical, community or applied settings including

  • assessment of sensitivity, efficacy, specificity, predictive and prognostic value, reproducibility and safety
  • medical devices, imaging, diagnostic and predictive tests
  • evaluation of diagnostic models, methods and methodologies in clinical or applied settings

 

Advice on research activities

Includes clinical and applied testing in humans, once verified in the laboratory, often in a trial or studies that involve a group of people.

Excludes pre-clinical investigation of potential diagnostics, which can include patient samples if they are being used in the diagnostic development phase. Such studies should be coded 4.1 Marker discovery.
 

Official terminology

Full name of code

Short name Unique ID
4.2 Evaluation of markers and technologies 4.2 Marker evaluation

HRCS_RA_4_2

 

Related external links

Common Scientific Outline (CSO) – 4.2 Technology and/or Marker Evaluation with respect to Fundamental Parameters of Method
 

Main inclusion criteria

Discovery, development and preclinical testing of novel markers (that may be derived from patient samples) and technologies for use in detection, diagnosis, prediction, prognosis and monitoring including

  • biological and psychological markers
  • diagnostic and monitoring devices, imaging, scanning, predictive and diagnostic tests
  • development and characterisation of models
  • diagnostic measures and methodologies

 

Advice on research activities

Note the word ‘discovery’ in this context is a medical term referring to determining if a marker is suitable for use in diagnosis/prognosis. This is distinct from the primary identification of candidates that may be potentially used as diagnostic markers, which would be coded in 2 Aetiology.

Therefore this code is suitable for use if potential diagnostic targets have already been identified in preliminary aetiological studies characterising specific pathways and these potential markers are now being verified in the discovery and testing stage.

Includes pre-clinical investigation of potential diagnostics, however these studies can include patient samples if they are being used in the diagnostic development phase.

Excludes clinical and applied testing in humans, once verified in the laboratory, often in a trial or studies that involve a group of people. Such studies should be coded 4.2 Marker evaluation.
 

Official terminology

Full name of code

Short name Unique ID
4.1 Discovery and preclinical testing of markers and technologies 4.1 Marker discovery

HRCS_RA_4_1

 

Related external links

Common Scientific Outline (CSO) – 4.1 Technology Development and/or Marker Discovery
 

Main inclusion criteria

Discovery and development of therapeutic interventions and testing in model systems and preclinical settings.

 

Advice on research activities

Should be used for development and characterisation of treatments and includes patient samples if they are being used in the treatment development phase.

Treatment development is not just ‘bench to bedside’ but can also be ‘bedside to bench’.
 

Official terminology

Full name of code

Short name Unique ID
5 Development of treatments and therapeutic interventions 5 Treatment development

HRCS_RAG_5

 

Related external links

Common Scientific Outline (CSO) – 5 Treatment
 

Summary of Treatment Development sub-codes

Main inclusion criteria

Discovery, development and evaluation of diagnostic, prognostic and predictive markers and technologies

 

Advice on research activities

Includes research where the main aim is to develop diagnostic or prognostic tests for clinical use.

Excludes development of lab techniques and tools for basic research.

Excludes basic research using imaging or detection techniques in the methodology, where the primary aim of the research is not to develop clinical tests.
 

Official terminology

Full name of code

Short name Unique ID
4 Detection, screening and diagnosis 4 Detection

HRCS_RAG_4

 

Related external links

Common Scientific Outline (CSO) – 4 Early Detection, Diagnosis, and Prognosis
 

Summary of Detection sub-codes

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