By Ray Tobey, Chief Medical Officer on Mar 7, 2018 9:00:00 AM
Pharma and biotech companies are always looking for ways to increase market size to help get their drug to those who may benefit. And, let’s be realistic here, they’d also like to increase return on investment for the enormous amount of money spent in development phase. One method that has garnered a lot of attention lately is performing clinical trials outside of US borders. This can add an additional level of complexity to an already laborious endeavor, however it can result in your drug being approved in multiple regions, worldwide.
Before taking your trials across the pond, there are multiple considerations to keep in mind to ensure you maintain the integrity of your clinical trial. We’ve listed some general tips, but we highly suggest you speak and work with a sponsor who has experience managing international clinical trials. There’s nothing quite like having experience under your belt to understand the complexities and nuances of conducting a trial of this magnitude.
Here are our top 5 tips:
- Be on the look-out for regulatory changes in the host country during trial
We all know that rules and regulations regarding drug development vary from country to country. But did you know that in many countries these regulations can change over time and quite rapidly? In the US, we are used to information overload, and it’s quite clear what the FDA recommendations entail, but in other countries this is not always the case. We suggest to have a specific member of your team to understand the regulatory rules, keep track of when changes occur and inform the team. It is important that everyone involved is aware of and understand how it will affect your trial and trial processes.
- Customize recruitment practices in each host country
Recruitment practices in other countries may not be the same as what we do here in the US. What some people in the States may think is helpful, in another part of the world they may find your activity intrusive. The more you understand the cultural boundaries, appropriateness, etc., the more likely you are to reach those who may qualify for your trial.
- Translate all information to which the patient is fluent
There is always a primary language of any given country. However, keep in mind when communicating relevant information you need to make sure all documentation is properly translated from English to the language in which the patient is fluent – which isn’t always the primary language of the country. Also, there are variations of English fluency among physicians and research staff so it’s important to translate supporting materials as required to ensure they understand the protocol and study requirements.
- Understand import/export rules for each host country
We live in an ever-evolving world were new threats and securities take place every day. Therefore, transporting biological material can vary day to day and be a paperwork nightmare. Make sure to understand the proper documentation needed to get your samples from point A to point B.
- Hope for the best and expect the worst
It’s sounds cliché, but it’s true. The more reasonable your expectations, and awareness of potential obstacles that could delay your timeline, the better your experience will be overall. Never underestimate the power of having a Plan B.