With the push for clinical trials to be more inclusive and represent more diverse populations, it’s no surprise that that the demand for international trials is growing. International clinical trials bring a lot of advantages for not only companies, but also oncologists and their patients. The demand for these trials is growing and with it means that many of the challenges of conducting international trials are starting to become easier to handle.
Challenges
Developing an international clinical trial is no small feat. From logistics, to funding, to regulatory approvals there are a lot of moving parts to consider.
One of the main issues that impedes these trials is the gaining regulatory approval in multiple countries. In the past, it was particularly difficult to get trials in multiple countries in the European Union because each of these countries had their own process for submission. In fact, as a whole, the European Union has seen a decline in clinical trials since 2007. To deal with these regulatory obstacles and to stay competitive with the rest of the world, the European Union created a new Clinical Trials Regulation that will streamline the application process, allowing for a single submission for multiple countries.
Logistics of a multi-country clinical trial are also an important challenge to overcome. It can be difficult to coordinate across trial sites in different countries especially when it comes to drug supply and biospecimen collection. However, the advent of digital communications and digital storage has greatly improved some of these issues. There are a number of web-based clinical data collection systems that can create improved logistics across many sites.
Advantages
Despite the challenges, international clinical trials are extremely important in advancing medical research.
The most notable is the ability to increase equity by allowing for patients with much broader genomic, biological, ethnic, and socio-cultural backgrounds to participate. This also helps expedite recruitment as it allows access to much larger patient populations.
International clinical trials are also hugely beneficial for rare tumor types or specifical molecular subtypes of disease. The increased access will allow for not only larger number of patients to participate but it could potentially vastly increase the accrual time for these trials.
Oncologists and clinicians can find many benefits from participating in international clinical trials. From development to execution, these trials increase the exchange of information from international collaborations, helping to facilitate learning and best clinical practices. Additionally, as most academic sponsors are focused on local trials, branching out to international trials can help clinicians understand issues with treatments that are not prevalent in their current practices, such as availability and cost.
Why Spain and Why MEDSIR?
At MEDSIR we are an international research organization the focuses on developing independent clinical trials in oncology. We provide academic researchers access to the same resources and administrative support mechanisms that commercial entities have to progress promising treatments efficiently. Because we have strong expertise in designing and running international clinical trials and have run many international trials, we already know the logistical hurdles that need to be overcome.
In addition to our international experience, Spain itself is a powerhouse for clinical trials. In 2019 Spain was ranked the 4th leading European country in number of clinical trials. Spain has seen constant growth of trials in early stages and has a large number of oncology trials. Ranked 8th best in the world, it offers high quality health care and universal coverage with the National Health System. Catalonia, where MEDSIR is located, leads the country in clinical trials. Spain is also known for its shorter timelines for start-up. Most importantly, trials in Eastern European countries offer competitive per patient costs, with lower clinical study costs and can lower costs by up to 50% compared to a trial run in the United States.
There are many benefits of running international trials in European countries, contact us If you’re interested in learning more about how to start your own international trial!
