According to clinicaltrials.gov Europe is home to the second larges number of clinical trials. During the COVID-19 pandemic, the number of clinical trials in this region significantly increased, especially we have seen that the number of trials is rapidly growing in countries like Spain, Italy, and Portugal.
The reasons why sponsors decide to execute their studies in Europe are multifold. There are 44 countries in Europe and depending on your type of study and other relevant parameters, it can be difficult to know which country should you choose?
Factors to take into consideration
- Access to a specific patient population
- Incidence/prevalence of the indication compared to other regions
- Recruitment speed
- A global commercialization plan for the product
- Regulatory reasons
- Lower costs of research compared to other regions
1. Recruitment Speed
Speed is always crucial and may be the main reason to consider specific countries in the European region. The first aspect to look at is the population that a country has, as well as the number of suitable, experienced clinical sites that can be activated.
In order to further determine the recruitment potential, also consider the availability and cost of standard care for patients and health care providers, the incidence/prevalence of the indication, as well as any sociocultural-related disease aspects.
2. Study Cost
When it comes to the cost of a study, the expenses of labor and site fees are typically highest in countries in Western and Northern Europe, such as the UK, Ireland, Sweden, Denmark, and the Netherlands.
Southern European costs for labor tend to be lower. Study costs in Southern Europe can be up to 30-40% lower compared with Northern European costs.
3. Regulatory Environment
The current European Medical Device Regulation provides the requirement for conducting clinical investigations in Europe. The regulatory pathway for starting a study is important to consider, in particular when the date of First Patient In is a relevant corporate milestone for a sponsor.
Next to study costs, start-up timelines, and recruitment speed, some sponsors are interested in detailed exchange with regulatory bodies (notified body) already in the early clinical development phase to ensure that a subsequent marketing authorization application addresses all relevant clinical development factors.
4. Investigator Motivation
Finally, an absolutely critical factor for study success is the motivation of a site and Principal Investigator (PI) to participate in and actively contribute to a clinical trial. There are countries in Europe where sites and PIs are more eager to participate in a study compared to other countries, and it is wise to choose a region where PIs and sites are generally very motivated to take part in research.
Financial remuneration plays an important role as well. While the site fees should always be within reasonable boundaries, it is still true that clinical research is an industry and the level of site fees influences the site´s motivation for participation.
Each study is unique and requires a special attitude and custom project plan, which corresponds with development goals and sponsor needs.
AKRN is strategically located in Madrid and we have all the capabilities necessary to support any clinical development program in the Southern European region. Our team members have significant experience in clinical research and have conducted clinical investigations in the majority of European countries.
Depending on the device type, stage, and specifics of the project, our clinical experts will suggest the best geographical location for the study and support the project locally.
Reach out to us directly to discuss your project and how we can be a valuable partner for you.