IMP or NIMP?
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I've posted this thread on the GCP forum who have recommended posting here.
In a placebo controlled trial the treatment arms are as follows: Treatment Arm A – IMP + Therapy A + Therapy B Treatment Arm B – Placebo + Therapy A + Therapy B Therapy A & B are both marketed products used per their authorised forms, and are typically used in combination with other drugs as part of a regimen. Should therapy A & B be classified as IMP? One line of thought is that they meet the criteria of background treatment and are therefore NIMPs. Another opinion is that they are part of investigational treatment regimens and are therefore IMPs? What is the impact of classifying incorrectly?
Claire van Leersum
From the GMP Committee
Typically, if Therapy A and B are licensed standard care treatments used as authorised but in combination with the IMP, these are not IMPs and you could possibly use the definition of a background treatment to also justify this. However, as the IMP definition in Volume 10 states, as long as Therapy A and B are used without change to formulation and/or packaging, or are not used for an unauthorised indication, or used to gain further information about the authorised form, then you fine to not define the therapies as IMPs. A marketed product used in a trial is really only considered an IMP if any of the above apply. If it is used completely as it has been authorised then you should be OK.
It follows then that if the therapies were used outside of their authorised indication, they would have to be classed as IMPs.
So, if the efficacy of IMP is to be evaluated when co-administered with Therapy A + B against a placebo (again combined with Therapy A + B) would it be okay to consider Therapy A & Therapy B as non-IMP? Both Therapy A & B are standard of care approved/licenced drugs for a specific cancer subtype. Also to confirm if it is mandatory for the sponsor to provide this SOC (source it or pay for it) even though it is reimbursed by NHS? In either case (paying or not) is it mandatory that sponsor has to provide labels for each of the SOC drugs for the trial purpose?