Supply chain integration should be prioritized during clinical trial protocol development rather than treated as an afterthought, industry experts emphasized at a recent conference in Seoul. This shift in approach could help prevent delays and operational challenges that frequently plague clinical research programs.
"[Supply chains] are often forgotten, being the very last cog of clinical research. That leaves clinical supply chains with a lot of constraints: the protocol, the systems, and manufacturing strategy," explained Amaury Jeandrain, clinical supply strategy adviser at N-Side, during the Outsourcing in Clinical Trials and Clinical Trial Supply East Asia conference.
Supply Chain Disruptions on the Rise
According to a recent GlobalData report, supply chain disruptions have grown both more severe and frequent over the past decade. The complexity and cost of restructuring supply chains means there are no quick solutions to these challenges.
Proactive Risk Management
Hye Jung Yang, clinical project manager at MedPacto, emphasized the importance of preventative approaches: "Using data to predict issues is much easier than reacting to them once they crop up." This proactive stance is particularly crucial for trials involving comparator medicines, which face unique logistical challenges in packaging and labeling.
Protocol Design Impact
Early supply chain consideration could significantly influence protocol design, potentially leading to more efficient trials. "If supply chain could influence protocol design, we could have protocols that are supply chain friendly," Jeandrain noted, highlighting how this approach could reduce drug waste and associated costs.
Managing Disruption Categories
Supply chain disruptions fall into two main categories, according to Jeandrain:
- Foreseeable disruptions:
- Minor shipping delays
- Temperature excursions
- Standard logistical challenges
- Unforeseeable disruptions:
- Geopolitical issues
- Quality concerns
- Comparator shortages
"[Unforeseeable disruptions] tend to create massive shortages in the entire clinical trial's supply chain. They not only put patients at risk but the trial itself," Jeandrain warned. He advocated for a comprehensive approach to mitigation strategies, emphasizing the importance of evaluating their feasibility, cost, and effectiveness before implementation.
Strategic Solutions
Experts recommend developing multiple contingency plans and carefully assessing their impact before implementation. The goal is to maintain trial continuity while avoiding unnecessary disruptions to recruitment or site operations when alternative solutions might suffice.
The discussion highlighted that while certain disruptions can be anticipated and planned for, others require flexible and robust response strategies. This reality underscores the critical importance of incorporating supply chain considerations into the earliest stages of trial planning rather than treating them as an operational afterthought.
