One task is to assist researchers in this field by providing advice and information on the impact of the Clinical Trials Directive on studies involving human subjects and pharmaceutical agents, which are not intended as trials of novel vaccines or microbicides. As part of workpackage 7, a working group is dedicated to exploring the implications of the EC Clinical Trials Directive as it applies to human based studies.
"Patient Characterisation Studies" versus "Clinical Trials"
Guidance document to help researchers distinguish CTIMPs from NIMPs
A guidance document has been prepared containing hypothetical examples of studies that are clinical trials, and ones that are not clinical trials, based on recent guidance issued by UK MHRA on what constitutes a Clinical Trial within the scope of the Clinical Trials Directive, and what is an Investigational Medicinal Product (IMP) and what is a Non- Investigational Medicinal Product (NIMP). The hypothetical studies are based on microbicides or vaccines against HIV, and so will be meaningful to clinical researchers in the field of HIV, vaccines and microbicides.
These examples have been developed in consultation with the Clinical Trials Unit of the UK MHRA.
Ongoing consultation is taking place with other Member States to broaden the guidance, and the updated versions will be posted here.
Readers are directed to the table of abbreviations and definitions at the end of this document for a description of the terms "clinical trial", "investigational medicinal product", etc.
These examples must be read as hypothetical guides, and investigators should not rely on their studies being classified the same way by their national or local authorities, even if very similar.
The science presented here is also merely illustrative and has been made-up.
To access this guidance document click here.
Real-life example of a "NIMP": sublingual challenge with HPV antigens
In addition, a clinical protocol for a genuine NIMP study, developed in collaboration with the FP7 Integrated Project EURONEUT41, and underway at St George's Vaccine Institute (www.vaccine.ac.uk) is made available as a practical demonstration of a NIMP study.
The protocol can be downloaded by clicking here. The Subject Information Sheet can be downloaded by clicking here.
The study has been registered with ClinicalTrials.gov (NCT00949572), and the entry can be accessed by clicking here.
Other sources of information
The UK Medical Research Council has a site dedicated to clinical trial regulations: http://www.ct-toolkit.ac.uk
The UK MHRA has guidance "Clinical trial authorisations: Is a clinical trial authorisation required?" on its website www.mhra.gov.uk (see this page).
It has also produced an algorithm to help decide if a study is a CTIMP, which can be downloaded by clicking here, and a set of examples related mainly to pharmaceuticals, which can be downloaded by clicking here.
Workpackage 7 coordinators
Sheena McCormack
Vicky Jespers
David JM Lewis |
