It is true that the focus is often disproportionately on patient recruitment and conventional wisdom has always been that if you can get the recruitment right, most of the challenges in a clinical trial are fairly manageable. However, in reality, unless the investigational drug is actually on site when those patients appear, nothing can proceed! Ten years ago, when the majority of clinical programs were conducted in the United States and Western European countries, delays in drug distribution were not a concern or really a factor in timeline delays. However today, with the huge increase in biological-based products, their associated temperature-controlled requirements and the concomitant migration of clinical trials to emerging regions, the drug-distribution portion of the clinical supply chain is of critical concern and can adversely impact timelines as significantly as patient recruitment challenges, if not managed correctly.

We would recommend that as soon as the clinical protocol is shared with the clinical team, in a multi-national program, you should share that information with your clinical supplies team. This will allow them to plan out the drug distribution and to identify potential obstacles, regulatory challenges and logistics considerations. In some instances, we have seen that insight into these types of considerations has made a sponsor company identify alternate countries to not risk the potential delay.