Getting your target therapeutic to patients sooner is the objective of every pharmaceutical company. At times, Sponsor companies and investigational sites can struggle to meet their clinical trial enrollment objectives. Often delays occur because the prospective sites might be limited in North America and Western Europe. Extending the trial to include other regions might add logistical challenges that your teams are not best prepared to address.
In nearly 240,000 reported studies, 47% were non-U.S. only, 36% were U.S. only, 6% were global and 12% unreported. Similarly, in 41,000 recruiting studies, 56% were non-U.S., 39% U.S. only, 5% global and 12% unreported. Although the specific countries are not listed in these top level figures, the data indicates a high percentage of participation outside the U.S. It might even be costing you more time, money and resources to ignore patient recruitment beyond traditional countries.
Simple ways to ensure your success are:
• Knowing Customs and Regulatory requirements per country
• Understanding climate and infrastructure nuances
• Considering the impact of language, work culture and religion
• Establishing supply distribution hubs
• Partnering with providers that solely focus on supporting clinical research across regions
Perhaps you’re worried about the costs associated with broadly producing and distributing drugs? Another common concern is wastage at slow-recruiting sites. For others, navigating the language and customs in foreign countries might be daunting. Engaging a diverse team with global expertise during the planning process might offset some of these issues. It is recommended that you consider engaging a team of specialists early on in the study planning stage. These specialists should be able to answer specific questions related to your program. Early planning allows time for you to address challenges and successfully deliver on global trial milestones.
I am pleased to share with you some case study examples that showcase global best practices in action.