Open research > Registering and reporting clinical research

Clinical Trial: A clinical trial compares the effects of one treatment, preventative intervention or diagnostic test with either another, or a control (no treatment/test). According to the HRA, clinical trials include: a clinical trial of an investigational medicinal product, a clinical investigation or other study of a medical device, a combined trial of an investigational medicinal product and investigational medical device, any other trial to study a novel intervention of randomised clinical trial to compare interventions in clinical practice e.g. trials of surgical interventions, radiotherapy, imaging, mental health investigations/therapies, physiological investigations, trials of non-medicinal products or devices or complimentary/alternative therapies. 

Clinical Trials of Investigational Medicinal Products (CTIMPS): Investigational Medicinal Products (IMP) are any medicine that is being tested in a clinical trial for its effectiveness as a treatment or being used as a reference point for the effectiveness of another treatment. They include newly developed drugs and licensed drugs that are being tested against a new condition or in a new formulation. A clinical trial of an investigational medicinal product compares the effects of an IMP against another treatment, or a control. 

Combined trials of an investigational medicinal product and an investigational medical device (IMP/IMD trials): An Investigational Medical Device is any instrument/implement (other than a medicine) used to diagnose, monitor, treat or manage a medical condition, whose effectiveness and/or safety is being studied. Examples include syringes, surgical tools, some medical apps, and soft and hardware e.g. continuous glucose monitors/pacemakers. A combined trial of an IMP and an IMD is trial that investigates these two things in parallel. 

The HRA: Is a ‘non-departmental’ public body, sponsored by the Department of Health. It protects and promotes the interests of the public and participants in health or social care research by ensuring research is safe, ethical, and transparent. The HRA co-ordinates and standardises health and social care research regulatory practice, research ethics committees and approvals for processing confidential patient information. The HRA’s function and scope is laid out in the Care Act 2014 with some functions relating to the Medicines for Human Use (Clinical Trials) Regulations 2004.

Sponsor: In non-commercial research (including charity funded), the sponsor is normally expected to be the employer (which may or may not be the funder) of the chief investigator and in commercial research, it is the funder. A sponsor takes overall responsibility for the effective and proportionate set up, running and reporting of a research project.

Registering and reporting clinical research