Why trial sites generally invite people living in their country

While recruitment for the FORTITUDE trial is ongoing, FSHD ETN clinicians receive many questions from people living in other countries in Europe and beyond who are interested in taking part.

Clinical trials have a limited number of places for participants. Trial sites usually need to give priority to people living in their own country, based on the clinical trial contract and their insurance issues . In many countries, people with FSHD have already expressed their interest in participating. Some have also contributed to previous clinical studies or to national FSHD registries and have been waiting for an opportunity to take part in a trial.

There are also practical reasons why taking part in a trial in another country can be difficult. Clinical trials may require several visits, and sometimes an additional visit is needed if an unexpected result is found during an examination. Travelling from another country can make this difficult. Even when participants are willing to arrange and pay for their own travel, there can be problems with travel, language, or communication. Research nurses and other trial staff are trained to work with participants in their own language, and not all trial teams can provide support in other languages. Essential trial materials, such as patient consent, patient reported outcomes, are frequently not available in multiple languages either.

This does not mean that people living in countries without a trial site cannot participate in future trials. Building trial opportunities in more countries is an important goal.