Quick links

Medical Device Clinical Studies

NIC Document

Summary

To market your medical device effectively, you need to demonstrate its clinical efficacy with evidence from pre- and post-market clinical trials. This guide introduces the steps you need to take to plan for and undertake a clinical investigation or trial.

In brief

  1. Planning, scheduling, and setting up a study
  2. Study and data management
  3. Study closure
  4. UK Clinical Research Network (UKCRN)
  5. Use of contract research organisations (CROs)

Introduction

The two main types of medical device clinical study are pre-market, and post-market. Pre-market studies, known as clinical investigations, are performed to gain safety and performance data. This is used to demonstrate compliance with the regulations for placing devices on the European market (CE marking). Post-market studies are where the device already has market approval (CE mark) and is being used for its intended purpose as part of a clinical study. The aim is to produce data that can support the manufacturer’s claims of device performance, clinical and cost effectiveness and benefits to patients. The clinical trial route-maps on www.ct-toolkit.ac.uk provide a very clear overview of the different stages of clinical trials. While they are designed specifically for trials of medicines, a great deal of the advice they provide is relevant to all clinical studies.

Planning, scheduling and setting up a study

Specific tasks involved with conducting a medical device study include:

Clinical investigation plan/protocol: All studies require a protocol containing the information required to conduct the study, including design, methodology, patient selection and the study procedures. In post-market studies, it may be appropriate to have early discussions with clinical investigators about the study design and methodology.

Case report form (CRF): Used to record information regarding patient status before and after the procedure and during the course of the study, the CRF is the main way to capture the information generated by the study. It is completed by the investigators or a member of their team. It may also be appropriate to consider using patient questionnaires if the device being studied is likely to have a direct impact on the patient’s functional status or quality of life.

Investigator’s brochure: This brings together all the information about the device and usually includes a literature review, pre-clinical data, device materials, instructions for use, packaging and labelling and all other relevant information.

Competent authority notification: You must notify the competent authority in each country where the study is to be conducted if the study involves a non-CE marked device, or a CE marked device not being used for its intended purpose.

Research Ethics Committee (REC) submission: For the majority of studies, both pre- and post-market, you will need to obtain ‘favourable opinion’ from a research ethics committee. This usually involves a full submission of the essential study documents.

Patient information and consent: The REC will review arrangements for gaining patients’ consent to participate in a clinical study. By receiving information about the study, the patient can decide whether to participate and sign the consent document.

Study management

Patient recruitment: This is crucial for the success of your study. Investigators or appropriate study site staff usually recruit patients. Selecting the right site early on will help you ensure that this stage goes smoothly. Adverse event management: An adverse event is any untoward medical occurrence in a subject, device-related or not. As part of the clinical research process, you should document these events. If they are classed as serious and/or device-related, you must report them to the regulatory authorities and research ethics committees in accordance with national legislation.

Study monitoring and audit: You should visit investigators regularly to ensure the study is being conducted and recorded in accordance with the protocol. Study monitoring involves full management of the study sites, with the study monitor generally looking after all aspects of the study.

Study closure

Close down visit: At the end of a study, you should visit each site to ensure that patient recruitment and follow-up assessments have been successfully performed, all completed CRFs are available, the Investigator File is up to date and the clinical investigation has been closed appropriately. Final study report/publication: Prepare a full report containing all the results of the study to provide the basis for CE marking submissions or presentations at conferences.

UK Clinical Research Network (UKCRN)

The UKCRN provides support for clinical research and facilitates the conduct of randomised prospective trials and other well-designed studies. You can find out more by visiting: http://www.crncc.nihr.ac.uk

Use of Contract Research Organisations (CROs)

A CRO is a specialised consultancy which deals with clinical research. Using a CRO will help you ensure that both the organisational and clinical aspects of a trial are in order.