Instead of terming this a skill set, I would recommend a project lead who is well versed in FDA, EMEA, and government regulations, for a start. Trials of scheduled drugs [drugs whose use and distribution are tightly controlled] must be managed according to a well-documented set of regulations, which are very specific in detailing the clinical supplies requirements. Because of the risks these products pose in terms of addiction or street resale value, there is a high risk of diversion and regulations are designed to prevent any possibility of this occurring, which makes our focus to simply follow very prescriptive guidelines.

For example, FDA regulations mandate that any scheduled drug that enters the European Union must stay in the original country to which it was delivered. No redistribution is possible. Trials such as these require scrupulous advance planning and then flawless execution.

That being said, the skill set required these days to manage any large clinical program is best suited to individuals who are highly analytical, detail-oriented, and strong communicators. Successful project execution in today’s environment requires a thorough logistical understanding, knowledge of risk assessment and mitigation planning, multi-cultural awareness, and leadership competencies.

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.