FOI release
FOI Previous decisions about whether an experiment is a CTIMP or a non-CTIMP
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2025/00324
Received 31 March 2025
Published 30 May 2025
Request
1. Before the MHRA outsourced the decisions about whether a scientific experiment on humans with drugs/substances/IMPs is a clinical trial (CTIMP) or not a clinical trial (non-CTIMP) to universities and other bodies, the MHRA used to make these decisions. For 30 of the most recent applications, could you please release a summary of the proposed study (e.g. abstract) and your decision on whether it is a CTIMP or a non-CTIMP, before the MHRA outsourced the decision-making process. 2. How do you monitor the universities that make these decisions and ensure that they are correctly categorising studies as clinical trials, and non-CTIMPs? I'm especially interested to know how you ensure that universities are not unnecessarily, *over*-categorising studies as CTIMPs. 3. Would this hypothetical experiment be a CTIMP or a non-CTIMP: a well known, GMP-manufactured drug is given at a safe dose in a one-off dose, double-blind, placebo-controlled RCT experiment to patients with a mental health condition to study the effects of this drug on an experimental behavioural measure (i.e. not clinical or safety outcome) in the lab. 4. Should the university regulatory bodies who make these decisions now be transparent and publish (1) applications and results; (2) the minutes/ways they make the decisions about specific studies.
Response
see attached
Documents
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