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Evolution Summit Press Release

 Marcus Evans






“Many clinical trials today face delays because of difficulties in recruiting the required number of patients within the timeline. Sponsors need to look at other regions outside the US and Western Europe, that have access to a large pool of motivated patients, without compromising quality or anything else,” says Roman Hrynchuk, Chief Operating Officer, SanaClis.

SanaClis was a solution provider at the Marcus Evans Evolution Summit March 2020.

Why does patient recruitment in some established markets lag behind Central and Eastern Europe? Why should sponsors look at Central and Eastern Europe for patient recruitment?

There are several reasons including differences in healthcare system setup, standard of care and market competition.

Competition is for patients, as there may be a number of competitive studies enrolling patients from the same pool, and competition for investigator resources. Every region has opinion leaders every sponsor wants to have in their study. Sites running parallel studies may have limited capacity. It is key to look at the number of competitive studies recruiting in the same territory, and to try to diversify to new territories that offer a better enrolment potential.

Central and Eastern Europe has proven itself as one of the most productive regions for clinical trials globally. The sites have good access to patient populations including treatment naďve. The site catchment area is typically substantially larger than the US and Western European sites. The quality of the work is at least as good as in those regions, if not higher. If we compare the outcomes of FDA inspections conducted globally, the sites located in Central and Eastern Europe have the best results and quality of data. From a cost perspective, the per patient cost is substantially cheaper.

The healthcare system in this region is substantially centralized, compared to other regions. That means that sites have access to hundreds of thousands of potential patients, so these sites can enrol substantially larger numbers of patients and can do it faster. Having a good and reliable site selection process can have a huge impact on study timelines and associated costs.

What causes patient recruitment delays? What unnecessary delays and costs can sponsors avoid by conducting trials in Central and Eastern Europe?

There are various factors that delay recruitment, including regulatory approval delays, a long contract negotiation process or delays with investigational products supply, but the most important thing is that the right sites were selected for the study. Will they find the patients that are needed in a timely manner? The number of studies that run into recruitment issues is quite high, so knowledge of the sites, and approach to site feasibility and selection is key.

Once subjects are recruited, they must make sure to retain them, so patients do not drop out before the study is completed. There are two aspects – motivation and burden to take part in the study. You may want to implement certain tools to improve patients’ participation in the study, however, additionally; sponsors should consider what motivates patients to take part in the study.

A big difference in Central and Eastern Europe is how much more motivated patients and investigators are, compared to the US and Western Europe. The more East you go, the more motivated and interested patients and investigators you have. That may be because of the country’s economic environment. Access to innovative treatment options might be limited. In developed countries patients have no issues receiving novel medicines, and can get reimbursed from their insurance company.

Clinical trial costs are increasing every year. What is a good way around this issue?

Indeed, costs are increasing year by year, which will eventually demand more sponsors to look at other regions to conduct studies. In such a highly competitive market, adding proven emerging markets is one of the best options available on the global market. From a population perspective, Central and Eastern Europe have no limitations. Investigators have the required qualifications. It is just about finding a reliable partner who can guide the sponsor throughout the regulatory approval process and who can recruit the strongest sites. Selecting the right CRO team is absolutely key.

For more information on the upcoming Evolution Summits contact minac@marcusevanscy.com or visit: http://www.f1.evolutionsummit.com


phone +357 22 849 378
email summits@marcusevanscy.com
web www.discovery-summit.com/
email PO Box 24797, CY-1304 Nicosia, Cyprus
 
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