The planning and delivery of IMP and placebo for clinical trials is a highly specialist area where most researchers and clinical trial managers have limited experience. KCTU has recognised this area as a particular risk for clinical trials, because poor planning can lead to long delays in study delivery and potentially catastrophic mistakes that could harm participants.
The KCTU trials pharmacist is available to collaborate on primarily multi-centre trials involving blinded intervention. Investigators can request support by submitting a completed KCTU support request form via ctu.co.uk. Where collaboration is agreed, the pharmacist will provide specialist intervention management support for investigators throughout the entire life cycle of the study.
At application stage, this will include advising on the most appropriate formulations, blinding strategies, stability testing, shelf-life issues, manufacturing costs, supply chain mapping and sourcing quotes from potential suppliers.
Once funding is awarded, the pharmacist will participate in TMG meetings, support the tendering process where needed, advise on quantities to be manufactured and the manufacturing schedule, review technical agreements, review relevant sections of the protocol and regulatory applications, advise on emergency code break processes and IMP storage conditions, support distribution of IMP and placebo to sites and plan stock levels based on recruitment rates achieved, advise on relevant study specific pharmacy documents and, where needed, liaise with the Qualified Person (QP) and the MHRA.