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
Following changes in EU legislation, nutritional and vitamin supplements are treated as pharmaceuticals. Therapeutic studies involving these substances should be coded as 5.1 Pharmaceuticals or 6.1 Pharmaceuticals.
Studies of the preventive effects of nutritional supplements should be coded as 3.3 Nutrition.
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