A Fresh Approach to an Evolving Interface

Most readers are well aware of the challenges associated with the set-up and management of the clinical supply chain: the push for small, generic packaging, limited bulk availability, the financial pressures on each trial and the reduced timeframes in order to reach ‘first patient in’ targets. Adding multiple vendors to this pressurised mix results in most trials requiring significant amounts of time and resources to maintain the supply chain and keep the patients on track. From a vendor’s perspective, similar issues and pitfalls reoccur between many sponsor companies and their partners within the supply chain.

The success and smooth running of clinical trials (in the context of trial supplies and patient randomisation) is influenced by decisions taken upfront in both construction of the IVRS and in relation to the packaging and labelling of the clinical supplies. As both of these activities are driven by the study protocol, it is critical to have input and agreement from the clinical team, supply team, IVRS and packaging vendors before documents are set in stone and timelines confirmed. We have identified several key interface areas that we believe, if managed correctly, can vastly improve the overall management of the supply chain and hence the delivery of medication to the patients.

PHANTOM CASE STUDY

To illustrate the points raised, we shall consider a phantom study – clinical trial 1234. The key variables of this trial are as follows:

• Three groups – active (drug x), comparator y, placebo (1:1:1 ratio)
• Total of 500 patients over 50 sites
• Each kit = run in carton, visit one carton, visit two carton and visit three carton
• Run in = one weekly wallet card – all placebo
• Visit 1,2,3 = five weekly wallet cards each
• Treatment = three months
• Countries involved = Russia, UK, Spain, Germany, Italy, Sweden, Brazil, Mexico, USA, Denmark and the Netherlands