6.1 Pharmaceuticals
Main inclusion criteria
Clinical application and evaluation of pharmaceutical small molecules, therapeutic vaccines, antibodies and hormones in humans including:
- small scale settings and pilot studies
- phase I, II, III and IV trials
- assessing sensitivity, efficacy, specificity, relapse, survival, therapeutic value, pharmacokinetics, reproducibility and safety
- studies monitoring response, outcome, drug resistance and side effects
Advice on research activities
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 |
| 6.1 Pharmaceuticals | 6.1 Pharmaceutical |
HRCS_RA_6_1 |
Related external links
Common Scientific Outline (CSO) – 5.4 Systemic Therapies – Clinical Applications
Advice on research activities
Pharmaceuticals are not always used in a therapeutic context – and therefore research involving pharmaceuticals will not always be coded to 5.1 Pharmaceuticals or 6.1 Pharmaceuticals.
Established pharmaceutical compounds may be used in studies investigating mechanisms of action or aetiology (e.g. by disrupting pathways or blocking transmission) and it would then be appropriate to code as 1.1 Biological or 2.1 Endogenous risks.
Pharmaceuticals may also be used in chemopreventative studies, which should be coded as 3.3 Nutrition and chemoprevention.
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
Research on chemopreventative agents and health protective effects of nutrients including
- development, characterisation and mechanism of action
- chemical contraceptives
- testing and evaluation in model systems and clinical, applied and community settings
- evaluation of evidence to inform policy
Advice on research activities
Includes studies focused on the potentially health protective effects of specific nutrients, probiotics and nutritional supplements plus chemopreventative studies including oral contraceptives.
Excludes general epidemiological studies of the effects of nutrition on health or association with disease.
Excludes studies where nutrients, probiotics and/or nutritional supplements are used as therapeutics treatments. Such studies should be coded as 5.1 Pharmaceuticals if in pre-clinical development or 6.1 Pharmaceuticals if in a clinical/applied setting.
Exclude studies on microbiota transplantation. These are consider cell treatments and should be coded as 5.2 Cellular and Gene Therapy for pre-clinical or 6.2 Cellular and Gene Therapy for clinical/applied.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 3.3 Nutrition and chemoprevention | 3.3 Nutrition |
HRCS_RA_3_3 |
Related external links
Common Scientific Outline (CSO) – 3.2 Dietary Interventions to Reduce Cancer Risk and Nutritional Science in Cancer Prevention
Common Scientific Outline (CSO) – 3.3 Chemoprevention and other medical interventions
Main inclusion criteria
Identification and characterisation of endogenous factors known or suspected to be involved in the cause, risk or development of disease, conditions or ill health including
- genes and gene products, molecular, cellular and physiological structures and functions
- biological factors linked to ethnicity, age, gender, pregnancy and body weight
- endogenous biological factors or pathways involved in responses to infection or damage by external factors
- metastases, degenerative processes, regeneration and repair
- complications, reoccurrence and secondary conditions
- bioinformatics and structural studies
- development and characterisation of models
Advice on research activities
To be used to code all biological causes of disease including the following
- Host cell biological responses to infection
- prion/TSE aetiological studies
- ischemic preconditioning
Characterisation of pathways to identify candidates that may potentially be used as diagnostic markers should be coded as 2.1 Endogenous risks and not 4.1 Marker discovery.
Characterisation of the biological cause of psychological conditions should be coded as 2.1. However 2.3 Psychological risks can also be used if the study includes investigation of symptoms and characteristics of the psychological condition.
Awards that are focused on therapeutic development or diagnostics will often yield information about the mechanism of a disease. However, this is generally a secondary outcome and shouldn’t be coded 2.1 unless this is clearly stated as one of the primary objective of the research.
Excludes basic immune and pain responses and wound healing studies that are not linked to a specific disease/condition stimulus and normal ageing or pregnancy not linked to a condition which should be coded as 1.1 Biological normal function.
Excludes normal cell cycle and normal DNA repair and replication which should be coded as 1.1 Biological.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 2.1 Biological and endogenous factors | 2.1 Endogenous risks |
HRCS_RA_2_1 |
Related external links
Common Scientific Outline (CSO) – 1.2 Cancer Initiation: Alterations in Chromosomes
Common Scientific Outline (CSO) – 1.3 Cancer Initiation: Oncogenes and Tumour Suppressor Genes
Common Scientific Outline (CSO) – 1.4 Cancer Progression and Metastasis
Common Scientific Outline (CSO) – 2.2 Endogenous Factors in the origin and cause of cancer
Common Scientific Outline (CSO) – 2.3 Interactions of Genes and/or Genetic Polymorphisms with Exogenous and/or Endogenous Factors
Main inclusion criteria
Studies of normal biology including:
- genes and gene products
- molecular, cellular and physiological structures and function
- biological pathways and processes including normal immune function
- developmental studies and normal ageing
- bioinformatics and structural studies
- development and characterisation of model systems
Advice on research activities
To be used for research involving normal biological function including the following:
- basic immune and pain responses and wound healing studies that are not linked to a specific disease/condition stimulus
- normal ageing or pregnancy not linked to a condition
- normal stem cell research into differentiation and basic developmental biology of stem cells not linked to therapeutic development
- protein structural studies
- bioinformatics
- normal cell cycle and DNA replication and repair
Excludes studies characterising proteins or pathways linked to a condition or disease.
Excludes studies of processes associated to cancer which are rarely ‘normal’.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 1.1 Normal biological development and functioning | 1.1 Biological |
HRCS_RA_1_1 |