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Trials and Evidence

“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.  Ethical approvals information and guidance is available from the Health Research Agency (HRA) which is part of the Department of Health and is part of the Research Infrastructure of the NHS, comprising the:

Image courtesy of Department of Health: The 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 called IRAS (Integrated Research Application System).

Clinical Trials and Evidence Associates Clinical Trials and Evidence Associates

MAE Consulting Group

MAE Consulting Group specialises in regulatory affairs, clinicial affairs, project management and compliance services support to SMEs with a focus on the medtech and in vitro diagnostics sectors....

Medilink North West

Medilink North West is a membership-based professional organisation with a remit to stimulate growth and innovation in the medical and health technology sector throughout the North West. It...

MIMIT

MIMIT™ (Manchester: Integrating Medicine and Innovative Technology) is the first international affiliate of the highly successful Center for Integrating Medicine & Innovative Technology...

NICE Medical Technologies Evaluation Programme

Innovative medicines, diagnostics, medical devices and technologies requiring substantial investment by the NHS are likely to need to be evaluated by NICE to determine whether they are clinically...

NIHR Clinical Research Network: Greater Manchester

The National Institute for Health Research Clinical Research Network (NIHR CRN) is the clinical research delivery arm of the NHS. It operates across England through a national coordinating centre...

NIHR Manchester Biomedical Research Centre

NIHR Manchester Biomedical Research Centre (BRC) connects world-leading researchers based at The University of Manchester and four NHS Trusts in Greater Manchester, with a joint vision to drive...

NIHR Manchester Clinical Research Facility

NIHR Manchester Clinical Research Facility (CRF) provides facilities for early phase clinical research studies in adults and children. Manchester CRF provides a safe, quality assured...

ORCHA

ORHCA are the Organisation for the Review of Care and Health Applications. Their mission is to help the public and health care professionals meet their health and wellbeing targets...

TRUSTECH

TRUSTECH is an NHS organisation that aims to improve healthcare through the development of innovative products and services. TRUSTECH works with NHS organisations, companies and regional,...

Definitions

These clinical investigations/trials are research projects to demonstrate clinical efficacy and safety.  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.

MHRA is the Medical Healthcare Regulatory Agency, which regulates new devices and drugs in the UK.  This type of regulatory agency is also sometimes referred to as the “competent authority” in European guidance. 

Good Clinical Practice (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? The Health Research Agency (HRA) has published a decision tool to help.

Is a trial required? There 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. Guidance for manufacturers is available from the MHRA.

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.

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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.

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