Collaborative Resource: Intro to Clinical Trials

What are Clinical Trials?

Health Interventions Studied in Clinical Trials

How can this be applied to Medical Technologies?

Clinical trials can:​

• Test the efficacy and functioning in practice of novel medical technologies​
• Test novel medical technologies against the benchmark of existing technologies within the field​
• Demonstrate the benefits of novel technologies, or redesigns of existing technologies when compared to existing and adopted technologies​
• Give scientific backing to novel technologies and begin an evidence-base that could lead to adoption within the wider field

Ethics: Do I need to apply?

The above flow chart demonstrates the decision tree for the different Ethics Committees that may apply to research conducted at Imperial. If you are uncertain as to which REC to apply to, check with your Chief Investigator.

For a more detailed look at Research Ethics, see the dedicated Research Ethics at Imperial Resource.

Clinical Trial Requirements

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. ​
• Investigate an intervention – the study treats or diagnoses its subjects with a drug, medical device, gene-therapy or other medical intervention. If your study is not an interventional trial, then it is likely an observational study (E.G.: a case-control, cross-sectional, or cohort study). ​
• Look for an effect – the study must collect data on measures chosen during trial design.​
• Compare 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.​
• Be prospective – subjects must be studied forward in time, which means retrospective studies are not classed as clinical trials.

 The MHRA has designed an algorithm to help researchers check if their project is classed as a clinical trial. You can access it here.

Clinical Trials - Trial Startup

Overview

Trial set up processes can vary between CTIMPs, non-CTIMPs and other trial types. The following advice is general, you should speak to your relevant departmental expert for more tailored guidance.

You should consider:

• The Research Question - The nature of the question will determine which regulations the trial must adhere to.
• Where are you in the trial process? - The key stages are shown in the pathway on the next page.
• Organisation and trial team expertise - Use the following pathway to identify any skills gaps in your team, and see the information on sourcing expertise at Imperial in the following pages.
• The importance of Patient & Public Involvement - Consider how best to involve members of the public in your work including using Imperial’s PPIE Team.

Clinical Trials Pathway

This diagram demonstrates the standard pathway that clinical trials follow. Items in black and green are standard items that will follow a set process, whereas items in blue may not apply to all studies, or may follow study specific processes. An example of this is "Contracts & Agreements" - The types of contracts, or other agreements, you need will vary depending on the nature of the project.

Created by the NIHR, the original diagram and surrounding information are available at Routemap (ct-toolkit.ac.uk) 

Trial Design & Planning

Good study design is important.

The trial design should be considered before the protocol is developed to ensure that all requirements are identified and met, particularly with regard to appropriate funding sources and amounts,

A good study plan will help with the development of funding applications, ethics committee and R&D approvals, NHS approvals, and any other regulatory permissions required.

Imperial offers a research design service that can support the development of your study design, find out more here.

Sponsor

The Sponsor is responsible for ensuring appropriate arrangements are in place for: 

• The Site Initiation Visit (SIV)
• The management and oversight of the project.
• The overall management of financing the project. 

More guidance on the process at Imperial can be found here.

Site Initiation Visit

Once all of the relevant approvals are in place, all documentation has been finalised, and all sites have the information they need, the trial can go ahead.​

Typically, a site initiation meeting, or “visit”, is held at each site (in person or virtual - N.B. The core research team must attend in person where possible). The Chief Investigator is then able to confirm all technical aspects of a trial and that protocol requirements are fully understood by all site staff, and necessary documents are in place.

The visit also provides the site team with an opportunity to ask questions.​ Trial or facility specific training normally happens at this stage.

Resources at Imperial

Facilities at Imperial

If you are an Imperial researcher or staff member, or if your project is Sponsored by Imperial, you may be eligible to access the Imperial NHS Trust Clinical Research Facility (ICRF). The ICRF is a clinical facility at Hammersmith Hospital, London, specifically designed to accommodate research projects.

You can find information on the ICRF here.

Spinouts at Imperial

Imperial is committed to supporting spinouts for Imperial-developed innovations. The point at which you spinout will depend on the specific innovation, and any specific project needs.

You can find further guidance on spinouts at Imperial here.

Resource Download / Contact Us

You can download a copy of these resources here: CollabResource - Clinical Trial Basics (PDF)  and here: CollabResource_Trial Startup_updated (PDF) . These PDFs include additional information, such as suggested reading lists, glossaries, and contact information.

If you would like to contact us, or if there is a resource you would like to see, reach out to us using this form!