Selection of Country and Site for Clinical Trials

The process of site and location (country) selection with the sufficient number of quality sites and investigators is one of the most challenging tasks in the organization of clinical trials. It requires the principal investigator (PI) to possess such characteristics as:

  • excellent medical skills in the given therapeutic area
  • access to acceptable facilities
  • time and willingness to commit to the study throughout its conduct period
  • administration skills
  • participation in study specific trainings, web conferences, etc.
  • willingness to participate in all required tests and visits
  • access to patients who meet the in/ex criteria of the given clinical trial.

 

When selecting partners/sites to conduct a clinical study, CROs take into consideration the following factors:

  • a proven track record in the given therapeutic area in a specific country
  • experience of the study team at the facility
  • statistics (such as duration) on patients involved in trials
  • assessment of real timelines with consideration of under-delivering or over-promising.

 

The Importance of Constructive Relationships

When conducting clinical trials in Europe, working relationships based on mutual trust and recognition – between PI and sponsors, and between CRO and sites – is one of top priorities. The entire process of clinical research requires dedicated work which is impossible without personal contacts among dedicated local experts. The importance of these contacts is higher among CEE investigators than in US sites.

Such constructive relationships can result in access to millions of patients, participation in hundreds of drug development projects, and effective management of operational challenges. The latter is especially crucial in such therapeutic areas as oncology trials, where patient costs are higher than in other areas. Besides, on the one hand, patients need their quality of life to be maintained, while on the other hand, for investigators, it is essential to minimize trial-related disruptions. In these terms, efficient partnership between sponsor, site and CRO allows to benefit from such “naïve” place for oncology trials as CEE region.

 

Special Aspects of Oncology Clinical Studies in CEE

The region of Central and Eastern Europe has long-standing traditions of its own in the area of cancer care. Groups of researchers in these countries collaborate closely with each other as well as with the EORTC.

It should be mentioned that unlike high-income European countries, the funding of cancer research in CEE states is considerably less, bringing to decline in group-driven clinical research. The shortage of funds is explained by limited pool of national research grants and lack of charitable organizations donating to cancer research projects. Nevertheless, most of CEE countries do have regional cancer centers equipped with well-trained staff for their multidisciplinary facilities. 

The major healthcare issue in many CEE countries is non-communicable diseases, particularly heart conditions and cancer. Leading in the statistics of cancer mortality cases in this region are Croatia and Hungary. The CEE countries leading in ongoing oncology trials in 2016 were:

  • Hungary – with 86 studies, which makes 6.1% of the total number of clinical trials in Europe
  • Poland – 57 studies (4.0% of the total European trial number)
  • Czech Republish – 50 studies (3.5%).

With CEE region accounting for about one-fifth of all European oncology studies, the share of oncology trials of these three countries in the total number of oncology trials in Europe (in 2016) is about 14.0%.

Another key factor in country selection for conducting clinical trials is the number of enrolled patients, which in CEE countries is also significantly higher (1.5x – 12x in most oncology indications) than in Western European sites. Thus, being a valuable contributor, these three CEE countries obviously possess the required capabilities and capacity for conducting international ontological clinical research in various indications.

When comparing the numbers of oncology trials ongoing in Europe in 2016, we can see that Hungary’s share of those trials (and consequently its contribution) is compatible to those conducted in Austria, Belgium and Denmark. Positions of Poland and the Czech Republic are also pretty high on this list:

Oncology clinical trials ongoing in 2016

Clinical Trials Register, 2016

 

Bottom Line

Clinical studies in CEE countries like the Czech Republic, Poland and Hungary have well-recognized research experience and long-standing traditions. These countries have also a record of their clinical research quality and high potential of patient recruitment. If expanded to other EE and CEE countries, clinical development programs can get access to a population of about 340 million.

The other factors to pay attention to when considering conducting clinical trials in Europe are the availability of patients and medical conditions which meet study selection requirements, and patients’ willingness to get enrolled for the study.

The other stakeholders of clinical trials – study teams and investigators – are strongly motivated to take part in a clinical study that besides medical benefits brings also scientific opportunities and paves a way to the wider international medical community.

This means that opting for CEE countries to conduct clinical trials, gives access to a richer patient pool and provides for faster recruitment – conditions that are difficult to access if restricted to only Western European countries and the USA. Added to this are the stakeholder commitment, well-equipped hospital infrastructure, and lower costs. Combined together, these factors make Central and Eastern Europe an attractive destination for conducting clinical trials. And possible risk and challenges can be mitigated by proper planning and local knowledge supported by expert management.