The choice of sites and investigators is extremely important for achieving Clinical Accelerator’s patient enrolment targets. We perform most of our studies in Central and Eastern Europe (CEE), including Bulgaria, Czech Republic, Estonia, Georgia, Hungary, Latvia, Lithuania, Moldova, Poland, Romania and Ukraine (listed alphabetically) with the total population close to 130 million inhabitants.
Central and Eastern Europe has become a major contributor of investigative sites to global clinical trials, currently providing over 10% of all sites worldwide. The region is especially attractive to sponsors thanks to the higher levels of patient recruitment that are characteristic of CEE countries. The average reported recruitment rate in CEE is 10.3 patients per site compared to 7.5 per site in Western Europe.
Centralized systems of healthcare with large hospitals and effective patient referral pathways; motivated investigators with considerable experience of conducting clinical trials; patients usually enthusiastic about clinical trials and available in large numbers – all these factors form a good basis for effective patient recruitment into clinical trials. When all these advantages are linked with our dedicated system of patient enrolment support, which uses a range of proven strategies, we achieve excellent results: we always recruit patients!
FDA inspections in the CEE region
It is unsurprising that facilities operating in CEE have attracted scrutiny from the FDA and other international regulators, given the high number of clinical trials being operated in the region. In the last decade, over 300 FDA inspections of Bioresearch Monitoring have been carried out in our countries of operation. The majority of inspections (according to 2018 data) have been conducted in Poland (109) – pushing them up in ranking above Canada (88) and Germany (96). Other contributors to the number of FDA inspections in CEE are Hungary (34), and Romania (31), Russia (67), Ukraine (29), Latvia (4), Lithuania (6), Estonia (3) and Georgia (17).
This reflects the growing status of CEE countries as leading global locations to conduct clinical trials.
FDA inspection outcomes
The results of these inspections have proved to be somewhat unexpected for some critics of the so-called “emerging locations” in CEE.
Based on the recent statistics available, our own analysis of FDA inspections outcomes shows that our countries of operation such as Poland, Georgia or Ukraine outperform Canada, Germany, and the UK. In the last decade, the percentage of NAI inspections (no objectionable conditions or practices were found during the inspection) was higher in Georgia (100%), Romania (74%), Ukraine (72%), Russia (66.3%), Hungary (65%) and Poland (58.5%), compared with Canada (54.4%), Germany (47.8%), and the UK (42.1%). For inspections where action was indicated, the average number of deficiency codes in Russia (1.24) and Poland (1.44) was lower than in Canada (1.67), the UK (1.95) and Germany (1.89).
Our own analysis is supported by previously published studies. A 2010 analysis of FDA data showed that Eastern Europe (with 264 US FDA inspections) has the best overall results worldwide, with only 3.3% of its site inspections having three or more deficiencies, 0.85% in Russia and 0% in the Ukraine, compared with 20.2% in Western Europe after 506 inspections.
A more recent analysis comparing CEE with Western Europe and the USA gives an equally positive account. Clinical trials in CEE are more likely to result in NAI (No Action Indicated) outcomes of FDA inspections. In our countries of operation 73% of inspections of Bioresearch Monitoring resulted in NAI in the last decade. In comparison, only 56% of inspections resulted in NAI in the USA. The average number of deficiencies per inspection is lower in CEE than in Western Europe and the USA, at 0.99, 1.99, and 1.59, respectively. Finally, the rate of inspections for which objectionable conditions were found, warranting regulatory and/or administrative sanctions, were lower in CEE (1%), than in the USA (2%) and Western Europe (4.5%).
Repeated analysis of FDA inspection data has shown what we’ve always believed at Clinical Accelerator – that clinical trials conducted in CEE are of an equally high standard to those carried out in Western Europe and Northern America. We believe that all the extensive evidence of the quality of clinical trial data in CEE acquired as a result of FDA inspections over the last 5 years should be very reassuring for international companies considering placing their clinical trials in this part of Europe.
Due to the fast growing contribution of these countries to global clinical trials and increasing interest of FDA, we expect more evidence of the quality of clinical trial data will emerge.