Multinational clinical trials play an essential role in the European Union. In 2019 alone, Europe hosted 2,900 multinational trials. This was the second-highest number of clinical trials for any region of the world, only behind the Pacific. But multinational trials come with risks.
First, multinational trials need to comply with regulations. The EU has made this easier with the EU Clinical Trials Regulation. However, the regulatory agency of every country participating in a trial still has to review the sponsor’s drug or device application. That makes multinational trials complex.
Second, multinational trials require monitoring, and sending monitors across multiple countries can present a large burden for trial sponsors and Contract Research Organisations (CROs).
Fortunately, technology can help EU countries hold multinational trials compliantly and remotely–and, in the process, expand to more countries and more diverse populations than ever before.
Why Multinational Trials Are Valuable for the EU
The European Union is a major player in clinical trials–but not as major as they could be. Germany, the EU’s leader in clinical trials, ranks 4th in the number of clinical trials overall–behind the U.S., China, and Japan. France and the Netherlands are the only other EU countries to make the top 10.
But EU countries have an advantage other countries don’t–the European Union itself. The European Commission (EC), Heads of Medicines Agencies (HMA), and European Medicines Agency (EMA) can work together to create unified standards that make it easier to run trials across the EU instead of just in one country.
The COVID-19 vaccine trials proved that multinational trials offer benefits for patients, sites, and sponsors:
- Patients have access to better medical treatments no matter where they live
- Sites and sponsors have access to larger and more diverse patient populations, making recruitment faster and more inclusive
Recognizing this, the EU set out to create new regulations to make it easier to run multinational trials across all of their member states.
Technology Helps with the EU Clinical Trials Regulation
To support multinational trials, the EU passed the Clinical Trials Regulation (CTR). The CTR brings EU countries together under a shared set of clinical trial standards.
The CTR also created the Clinical Trials Information System (CTIS) database, which serves a few major purposes:
- Allowing sponsors to submit one clinical trial application to all EU regulatory agencies
- Making it easy for EU regulatory agencies to review the application and authorise, refuse, or request further information on the trial
- Giving the public a searchable database where they can find more information about trials
The Clinical Trials Information System will make multinational trial start-up much faster, since sponsors can now submit a single application instead of applying to the regulatory authorities of each EU country individually.
But the CTIS also makes the use of technology essential.
All trial documents–both those generated by the sponsor and those sent from sites–need to be submitted to regulatory agencies electronically. So generating those documents electronically in the first place will save time and prevent costly errors caused by duplicate data entry.
Because of this emphasis on electronic documents, EU sites and sponsors need compliant, efficient technology that lets them instantly share documents and data with each other. Site electronic Investigator Site Files (eISFs) with remote monitoring for sponsors offer one way to meet this need.
For additional information on EU regulations, check out:
Remote Monitoring Links Multinational Trials
Remote monitoring has the power to make multinational trials more efficient and to help them reach more patients.
eISFs with remote monitoring capabilities have exploded in popularity in the U.S., with 77% of sites planning to give their sponsors remote access to documents and data by the end of 2022.
The ACT EU initiative, created by the EC, HMA, and EMA, encourages European clinical trials to follow this trend by embracing streamlined monitoring methods. A Florence survey of Clinical Research Associates (CRAs) showed that with remote monitoring:
- 76% of CRAs monitor sites more frequently
- 75% of CRAs identify risks with site documents sooner
- 66% of CRAs spend less time on repetitive tasks
Remote monitoring is especially critical for multinational trials. Previously, trials were limited in how many countries they could reach by how much traveling CRAs had to do.
With remote access to the eISF, CRAs can spend less time traveling to sites by car or plane and more time monitoring. They can also spend their time on-site looking for safety risks and getting to know the site staff instead of just reviewing documents.
Expanding the number of sites where trials take place also expands how many patients can reach, which can make a tremendous difference in bringing trials to patients who’ve never had access to them before.
For additional information on remote monitoring, check out:
How Multinational Clinical Trials Can Increase Inclusion
Like North America, Europe struggles with including diverse patients in clinical trials. This is a major issue, because factors like age, gender, and race can impact a new treatment’s effectiveness. In fact, as many as 1 in 5 newly approved drugs have different effects depending on a patient’s race.
For example, Nature found that only 0.08% of participants in EU genetic trials for Type II diabetes were of Middle Eastern descent. Yet rates of type II diabetes are rising quickly across almost every Middle Eastern nation, and the number of EU residents originally from Middle Eastern nations is also growing quickly.
Although the UK is no longer part of the European Union, it struggles with similar diversity issues. In the UK, roughly 14% of the population is Black, Asian, or Middle Eastern, but only 5% of that population has ever participated in clinical research.
There are many reasons for this lack of representation in clinical trials, and multinational trials can’t solve all of them.
Building trust that was destroyed by historical abuses, like the Tuskegee syphilis study, will require long-term, concentrated efforts from the clinical research industry. So will increasing the diversity of clinical research staff and investigators.
But many people also can’t participate in clinical trials because they don’t live near the major hospitals, universities, or academic medical centers (AMCs) where trials are held. This is where technology and multinational trials can help.
How to Bring Clinical Trials to More EU Patients
Although technology and multinational trials can’t solve all of the EU’s problems with inclusion, they can solve one major problem: access.
Previously, clinical trial access has been limited on both a national and local level. On a national level, high-income countries have more than 100 times the number of clinical trials per capita that low-income countries do.
On a local level, clinical trials have mostly been offered to patients who live near hospitals, universities, and academic medical centers in major cities–or to patients who could afford to travel to those locations. Patients also needed to be able to attend on-site appointments for hours at a time.
This traditional model excluded patients who:
- Lived far away from major academic medical centers
- Couldn’t afford childcare
- Worked strict hours
- Relied on public transportation
- Found it difficult to travel because of disabilities or illness
But technology can give patients greater access to trials on both a national and local level.
How Technology Solves Problems with Access
On a national level, sponsors who have enough funding to support trials can hold multinational trials across high, middle, or low-income countries.
The EU CTR has made it far easier for sponsors to submit trials for approval in multiple EU countries. Then, eISFs with remote access empower CRAs to perform remote site monitoring in all of those countries without having to spend hours on a plane just to check documents.
On a local level, eISFs with remote access can bring clinical trials to local pharmacies, clinics, and physicians’ offices, instead of only to major hospitals or AMCs. Larger coordinating centers can help these smaller sites with gathering documentation and data remotely, and the smaller sites can focus on seeing patients.
Patients can then travel a short distance to appointments in their own neighborhoods, improving their trial experience, saving them time, and preventing them from missing work or needing to find childcare.
For additional information on increasing patient access, check out:
Technology Can Transform Multinational Clinical Trials
The EU Clinical Trials Regulation offers trial sponsors a streamlined regulatory environment where they can reach an array of diverse countries with just one application. By taking advantage of this environment, sponsors can bring multinational trials to more countries, cities, and patients than ever before.
But to make this vision a reality, sponsors and sites must embrace technology that connects them to one another and enables remote monitoring across countries. With this tech in place, EU nations can change the clinical trial landscape and bring cutting-edge treatments to more patients than ever before.
If you’d like to learn more about how clinical trials are changing in the EU, check out our guide to the EU Clinical Trials Regulation for sites and sponsors.