Stratified medicine, precision medicine and personalised medicine
Advice on research activities
Classification of research is context dependent and the coding guidance for assigning research activities is to identify the appropriate main code group first, then assigning a sub-code within it.
If the work relates to diagnostic or prognostic testing to inform treatment decisions, it would be more appropriate to code to 4 Detection and Diagnosis; in most cases using 4.1 Discovery for pre-clinical development and 4.2 Evaluation for clinical use.
If the work is development of new treatments in a pre-clinical or model setting, it would be more appropriate to code to 5 Treatment Development. This includes studies of pharmacogenetics for new therapeutics, which shold be coded as 5.1 Pharmaceuticals.
If it is clinical research using a precision medicine approach then it would be more appropriate to code to 6 Treatment Evaluation for the intervention being evaluated.
Main inclusion criteria
Identification and development of pharmaceutical small molecules, therapeutic vaccines, antibodies and hormones including:
- drug screening and development of delivery systems
- mechanism of action including side effects and drug resistance
- pharmacogenetics, prediction of genetic variation and responses to drugs
- testing in in vitro and in vivo model systems
Advice on research activities
In general this code should be used to characterise therapeutic targets rather than for their initial identification. It includes mechanism of action but should not be used to code studies where agonists or inhibitors are used as part of the methodology to understand the mechanism of other systems.
Includes mechanism of action and resistance to therapeutics. This includes characterisation of antibiotic resistance genes and mechanisms in bacteria which should not be coded as 2.2 Physical risks for cause of disease.
Includes studies predicting responses to therapies.
Includes studies of nutritional supplements used as treatments for disease.
Excludes studies focused on the potentially chemopreventative / health protective effects of specific nutrients, probiotics and nutritional supplements, which should be coded 3.3 Nutritional Prevention.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 5.1 Pharmaceuticals | 5.1 Pharmaceutical |
HRCS_RA_5_1 |
Related external links
Common Scientific Outline (CSO) – 5.3 Systemic Therapies – Discovery and Development
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
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