Is Your Study a Clinical Trial?
To be considered a clinical trial, a study must:
Be conducted on human subjects – no study in non-human animals is considered a clinical trial. If your study involves non-human animals, you should contact (AWERB.Secretary@manchester.ac.uk)
Investigate an intervention – the study treats or diagnoses its subjects with a drug, medical device, gene-therapy or other medical intervention. If your study not an interventional trial, then it is likely an observational study (E.G.: a case-control, cross-sectional, or cohort study) Please contact (FBMHethics@manchester.ac.uk) about observational studies.
Look for an effect – the study must collect data on measures chosen during trial design.
Compares the intervention to a control – a portion of subjects are given no treatment, a placebo, or the best available treatment other than the intervention. The effects for both the intervention and control group are compared.
Prospective – subjects must be studied forward in time, which means retrospective studies are not classed as clinical trials. If your study is retrospective please contact (FBMHethics@manchester.ac.uk)
MHRA Clinical Trial Algorithm
If you are still not sure whether your study is a clinical trial, the Medicines and Healthcare Products Regulatory Agency (MHRA) has devised an algorithm to help you make this decision.
As well as helping you decide if your study is a clinical trial, this algorithm also helps you determine what type of clinical trial it might be. Your clinical trial may be:
- A Clinical Investigation of an Investigational Medicinal Product (CTIMP)
- An Advanced Therapy Medicinal Products (ATMP)
- A clinical investigation/trial of a medical device (MD)
- A non-CTIMP (Investigate a diagnostic tool or treatment that does not qualify as a CTIMP, ATMP, or MD / uses drugs, but not in an investigational capacity, and measures a clinical outcome / uses drugs in an investigational capacity but not to measure a clinical outcome)
If you are still in doubt, please contact us at (firstname.lastname@example.org). You can no longer contact the MHRA for their opinion, this service is obsolete.