Clinical Trials of Investigational Medicinal Products in Jersey (FOI)Clinical Trials of Investigational Medicinal Products in Jersey (FOI)
Produced by the Freedom of Information officeAuthored by Government of Jersey and published on
16 May 2024.Prepared internally, no external costs.
Request
A
How many patients in Jersey took part in a clinical trial involving an investigational medicinal product (CTIMP) in 2023? How many on average in the last five years?
B
What are the names of the clinical trials involving an investigational medicinal product (CTIMP) that patients have taken part in via Jersey General Hospital in the last five years?
C
How many of the above trials have been part of multi-centre clinical trials, with Jersey General Hospital acting fully as a trial site without participants needing to travel to the UK to a different hospital or without the study being managed at a UK hospital?
D
How many of the above trials have been run through a hospital in the UK with Jersey General Hospital referring participants into trials managed by UK hospitals?
E
How many clinical trials have been granted a Clinical Trial Certificate in the last five years? Were these part of multi-centre trials that were also run in other countries such as the UK or were these single-site trials run exclusively in Jersey?
Response
A to E
The Medicines and Healthcare products Regulatory Agency (MHRA) defines an Investigational Medicinal Product (IMP) as:
“…any medicinal product which is being tested within a trial or any product, including placebo, used as a reference in a clinical trial. This includes products with a marketing authorisation where the product is:
- used in a different form from the marketing authorisation
- used for an indication not included in the summary of product characteristics for that product or
- used to gain further information about the product as authorised in the clinical trial authorisation.”
Medicines and Healthcare products Regulatory Agency 2011, MHRA produced FAQs for Investigational Medicinal Product (IMP), GOV UK, accessed April 2024,
This type of trial would go to the Research Ethics Committee for review and, generally, these are more likely to be trials where Jersey is joined as a site to an existing NHS Clinical trial. Over the last five years, Health and Community Services (HCS) has been involved in two clinical trials using IMPs:
NOAH trial commenced in 2016.
Jersey joined in 2017.
The last patient out of it was December 2022.
HCS received the formal closure of trial report in December 2023.
AZTEC (Azithromycin for Chronic Lung Disease of Prematurity) trial commenced in 2019.
Jersey joined as a site in 2021.
Study remains open.
Fewer than five patients were enrolled in these clinical trials through HCS. As numbers are small, disclosure control has been applied to protect the privacy of individuals. Article 25 of the Freedom of Information (Jersey) Law 2011 has been applied.
Article applied
Article 25 - Personal information
(1) Information is absolutely exempt information if it constitutes personal data of which the applicant is the data subject as defined in the Data Protection (Jersey) Law 2018.
(2) Information is absolutely exempt information if –
(a) it constitutes personal data of which the applicant is not the data subject as defined in the Data Protection (Jersey) Law 2018; and
(b) its supply to a member of the public would contravene any of the data protection principles, as defined in that Law
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