Common Pitfalls in Multinational Clinical Trials

Multinational clinical trials are challenging. The international industry is rapidly maturing, but horror stories are still common: 

• “Our study drug is melting in a hot locker in customs, and I can’t get hold of anyone.” 
• “Sure, that country enrolled like gangbusters, but the data was garbage.” 
• “I have a hard time even understanding the local project manager on our weekly calls.” 
• “The regulatory agency responded with a single question and no details.” 
• “My highest enrolling investigator is demanding the latest iPad to keep enrolling.” 

Despite the challenges, the pressure to conduct clinical research internationally is stronger than ever. However, every country is different, with its own evolving advantages and challenges. In addition to enrollment, cost, time and sometimes even data quality advantages, countries like Poland, China, India and Brazil are rapidly expanding markets that require local trials for marketing approval.