Science is an international effort, but only relatively few clinical trials are multinational. The vast majority of clinical trials are executed within single countries but those that are multinational have some fascinating characteristics. In this article, we’ll explore the characteristics of the most internationally collaborative clinical trials.
To kick things off, let’s use the Trial Finder dashboard to filter the studies on the count of country involvement. By default the dashboard is looking at currently active trials with start dates in the last 6 months.
Surprisingly, the top result is a study involving a whopping 42 different countries is a Phase 3 trial funded by industry. We’ll take a closer look at that study later, but first, let’s look at the general trends of clinical trials that involve multiple countries.
Industry Ties Transcend National Boundaries
The obvious trend is that it is almost exclusively industry sponsors who fund multinational clinical trials. This is because of the cost and operational logistics. It’s not until after the top 50 entries in the dataset do nonprofit or publicly funded entities start to crop up.
While the major pharmaceutical companies are responsible for funding many of the clinical trials that span 5 or more countries, there are still some active international collaborations between individual institutions in a peer to peer fashion. Also of note is that NIH-funded and US federal government funded trials barely show up in our analysis.
What Phases Are Internationally Collaborative Trials?
The majority of the trials which feature collaboration with more than three countries are in Phase 3, although there are a couple of Phase 2 trials and even a couple of Phase 1 trials. Nearly all of the clinical trials which span multiple countries, greater than 10 are interventional rather than observational. When one considers this, it is not surprising because of the geo-political and ethnic differences which do not allow for multinational observational studies to be easily conducted. It is much easier to conduct these on a country basis, or region basis.l.
More On The Study That Spans 42 Countries
As mentioned earlier, there is one clinical trial that is enrolling subjects in 42 countries. The trial is conducted by Abbvie, and is investigating the drug, risankizumab in 2 formulations, in patients with Crohns disease. Here is the trial record of it on ClinicalTrials.gov.
This study has been running for nearly a year and has enrolled with over 365 study locations in the following 42 countries:
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
Recruitment is planned to continue until October 2019. Interestingly they are aiming to recruit 940 subjects, which translates to a very low number per site.