Over the last 10 to 15 years, we’ve seen an increasing number of global clinical trials. Today, clinical trials are conducted in more than 140 countries worldwide, and according to a 2013 report from the US National Library of Medicine, nearly 31% of the world’s clinical trials are conducted outside of the United States.
While the growth of international clinical research creates exciting opportunities, it also introduces new challenges. The following are some of the most common obstacles organizations face when implementing a global clinical trials program – and how to overcome them.
- Regulatory barriers.
Regulatory frameworks differ from country to country, so it’s critical that your team has a solid understanding of the regulatory and oversight requirements in each of your targeted countries. Keep communication open with regulatory agencies, starting from the research and planning phases of your trial and continuing all the way through execution.
You’ll want a clear plan for your work approach. Will you have in-country representatives, or do you plan to outsource for site evaluations, data management, etc.? Consider these questions from the outset, because many of these activities begin long before trial activation.
- Scientific and ethical considerations.
What’s acceptable in one country may not be in another. When considering a country for a clinical trial, you’ll want to first be sure that it doesn’t have any regulations against any part of the study design, concept, or overall goal.
- Online advertising.
The online advertising landscape changes frequently – no matter what country you’re working in. So, do your homework before running online media for an international clinical trial. Talk to your local media consultant or recruitment agency before you start a campaign.
- Quality of care.
It is important that the countries you’re entering have the infrastructure to support your trial. This means not only enough safe, sanitary facilities, but also access to these facilities. Ask an investigator to research potential sites before committing to them. You’ll want to ensure that these locations will be sufficient for your trial.
Are you interested in learning more about international clinical research? Check out our newest OrangePaper: Executing successful global clinical trials.