Table 1 Seven major categories of clinical research
Categories | Includes |
|---|---|
Clinical trials on medicinal products | -phase I to IV trials |
-biotherapy trials (gene therapy, tissue engineering and cell therapy) | |
-biopharmaceutical trials (blood-derived products, monoclonal antibodies, recombinant proteins) | |
-vaccines trials | |
-fixed combination of medicinal products | |
-multimodal trials | |
Clinical trials on medical devices | -devices alone |
-devices combined with medicinal products | |
Devices are considered either as authorised (bearing the European conformity (CE) label and used within its indication or intended purpose), or as non-authorised (non CE labelled or used in another indication) | |
Other therapeutic trials | -radiotherapy trials |
-surgery trials | |
-transplantation trials | |
-transfusion trials | |
-trials with cell therapy (when the cell preparation is not considered as an investigational medicinal product) | |
-physical therapy trials | |
-psychotherapy trials (without medicinal product) | |
Diagnostic studies | -diagnostic or imaging studies without medicinal product or medical device |
Clinical research on nutrition | -nutritional studies |
-studies on nutritional supplements | |
Other interventional clinical research | -complementary and alternative medicine, |
not using medicinal products nor medical devices | -collection of blood or tissue samples or other fluids |
-physiology studies | |
-physiopathology studies | |
-psychology studies. | |
Epidemiology | -interventional and non-interventional pharmacoepidemiology |
-interventional and non-interventional epidemiology | |
-retrospective studies | |
-registries of patients |