How Pharmaceutical Companies Can Ensure Compliance with Foreign Clinical Research Regulations

Did you know that a majority of clinical research now done exclusively in the United States has dropped to less than forty percent? According to an FDA clinical investigator training course, 60% of all studies submitted to CDER had data from a foreign source. This is a tremendous shift in how the drug market used to operate when wealthy countries like the United States would typically conduct all clinical research within its borders. Now, pharmaceutical companies in the United States are much more likely to venture overseas to do that same research. In a 2007-2008 review by the FDA, 60% of all foreign clinical research was conducted in Western Europe while the rest was spread out across the rest of the world.

There are several significant drivers that have facilitated this shift in thought. First and foremost, there are the inherent costs involved with clinical research. Pharmaceutical companies discovered that they could save money on salaries and other operational conducts by conducting trials overseas. In addition to that, there has been a growing pool of contract research organizations (CROs) to choose from that can conduct the clinical research less expensively without affecting compliance. Pharmaceutical companies would also point out that performing foreign clinical research provides them with a larger number of patients whom they can study the effects of the drug on to gain better insight.

Because of a growing number of clinical trials outside of the United States, the FDA has acted to globalize its clinical investigators. For example, in 1997, 86% of clinical investigators were based in the United States with only 9% in Western Europe and another 5% located in the rest of the world.

In just ten years, the percentage of US-based clinical investigators went down to 57%. That's because 14% of FDA clinical investigators were now in Western Europe and 29% were based in other places around the world. In addition to an increase in global inspections, the FDA updated its regulatory requirements in order to reflect these changes.

Therefore, pharmaceutical companies must apply industry-standard best practices to ensure compliance with all clinical research regulatory affairs. In addition to supplier quality management processes to vet CROs, they must also invest in medical translation services to create consistency throughout the lifecycle of the drug or medical device. The FDA may reject applications that don't meet their strict translation requirements. These regulatory requirements should only grow more stringent with the proliferation of outsourcing, making quality control so important in the clinical research stage.