Appendix 4: Clinical Trials Definitions
In order to ensure appropriate and nationally comparative measurement against QPIs developed it is of utmost importance to agree consistent definitions of the various terminologies utilised.
The Clinical Trial QPI SLWG has therefore agreed the following definitions:
|Research||Research can be defined as the attempt to derive generalisable (i.e. of value to others in a similar situation) new knowledge by addressing clearly defined questions with systematic and rigorous methods. This excludes: audit; needs assessments; quality improvement and other local service evaluations. It also excludes routine banking of biological samples or data except where this activity is integral to a self-contained research project designed to test a clear hypothesis  .|
|Interventional Clinical Trial||A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions  .|
|Translational Research||Translational research transforms scientific discoveries arising from laboratory, clinical, or population studies into clinical applications to reduce cancer incidence, morbidity, and mortality  . The development of the breast cancer drug trastuzumab (Herceptin) is an example for this kind of research. Researchers derived knowledge about the function and presence of a specific gene ( HER) from laboratory studies. This information was then used to develop trastuzumab (Herceptin), which inhibits the growth of cancerous cells in patients whose cancers over express the protein coded by this gene.|
Email: Chris Booth