?Trials? are required for different reasons to satisfy different requirements, whether that be to determine a new technology is safe and effective (i.e., to provide evidence it meets a regulatory requirement) or whether it meets the needs of an organisation (i.e., to provide evidence it meets a procurement specification/ the buyer?s needs).
A manufacturer may need to carry out a clinical investigation (also referred to as a clinical trial) as part of a CE marking process for a new device or for an existing device being used outside its intended purpose).
In law (Medical Device Regulations 2002 No. 618) you must notify the MHRA if you are going to do an investigation of a non-CE marked device at least 60 days in advance of the start of the tests. This notification costs between ?3820 and ?5040 depending on the class of device. The MHRA then issues a ?notice of no objection? to allow the trial to proceed which is required as well as ethical approval for clinical research.
Most clinical investigations pre-CE mark will be classed as research, and therefore require ethical approval as well as regulatory go ahead.ÿ Ethical approvals information and guidance is available from the Health Research Agency (HRA) which isÿpart of the Department of Healthÿand is part of the Research Infrastructure of the NHS, comprising the:
- Health Research Authorityÿ(HRA)
- National Institute of Health Researchÿ(NIHR)
- NIHR Clinical Research Networks
Image courtesy of Department of Health:ÿThe health and care system explained
A typical clinical research investigation will require funding to cover activity including (but not limited to): finding and contracting with a clinical site and a clinical investigator; writing a detailed research protocol (outlining what tests are to be done and why), writing research participant information and consent forms (if applicable) and other study documentation; writing an ethics application and submission for ethical review; project management of the trial/data gathering including checks the trial is being conducted correctly to international standards of Good Clinical Practice (GCP); analysis and reporting of data.
Both MHRA and ethics applications are made online using a system calledÿIRASÿ(Integrated Research Application System).
Theseÿclinical investigations/trialsÿareÿresearchÿprojects to demonstrate clinical efficacy and safety.ÿ Sometimes procurement use the term ?clinical trial? to refer to an audit or ?pre-use? evaluation of a new device in order to demonstrate it is fit for purpose in the organisation and as part of a procurement exercise.
MHRAÿis the Medical Healthcare Regulatory Agency, whichÿregulatesÿnew devices and drugs in the UK.ÿ This type of regulatory agency is also sometimes referred to as the ?competent authority? in European guidance.ÿ
Good Clinical Practiceÿ(GCP) is embedded in law to protect research subjects. The main principles of GCP (also referred to as ICH GCP) set out specific responsibilities for the sponsor and the investigator (and others) involved in clinical research, and this is the legal basis for requiring clinical research protocols, informed consent of subjects, ethical approval and suitable review of the standard of the intended research study.
Helpful tools and resources
Is my study research?ÿThe Health Research Agency (HRA) has published aÿdecision toolÿto help.
Is a trial required?ÿThere are exceptions to every rule. A trial may not be required if for instance the medical device is manufactured in house at a healthcare establishment or if it is off-label use of a medical device in a clinician-led study.ÿGuidance for manufacturers is available from theÿMHRA.
The GM AHSN works very closely with the NIHR Clinical Research Network: Greater Manchester (CRN) to support the recruitment of patients into trials. The Greater Manchester CRN covers the same geography as the GM AHSN.
Are you interested in working with the GM AHSN to provide support to businesses working in the healthcare sector? Would you like to be listed as an Associate on the Innovation Nexus portal? Contact us to discuss how we could work together.