Cromos Pharma continues with a series of briefs devoted to clinical trials statistics in the geographies of its clinical operations. The first brief covering to the Republic of Georgia can be found here.
Emerging markets (CIS/CEE/Asia-Pac) continue to attract the increasing number of clinical trials. This is clearly predicated by both lower costs and faster patient recruitment that these geographies offer. Poland is one such market that has significant importance. The key drivers of Polish clinical trials market are its population size, efficient patient recruitment and high quality of study execution, which is largely a product of high quality of local medical staff.
General information about clinical trial approval process in Poland. Regulatory Agency/Competent Authority (RA) and Ethics Committee (EC) approval is required prior to any new drug or non-CE marked medical device clinical trial initiation in Poland.
The Clinical Trial Application (CTA) should be submitted to the RA by the clinical trial sponsor or its authorized representative. Application for drug studies can be made to RA and EC in parallel, however, the CTA for medical devices must be made to the RA after EC approval has been obtained.
RA requires that the contracts of all participating sites in Poland must be signed and submitted to RA before the CTA submission or between the CTA submission and the end of 60-day period of CTA approval process.
From all Principal Investigators participating in the study in Poland a Country Coordinator must be chosen and his/her local EC becomes the Central EC (CEC) responsible for review and approval of the proposed study. If the local ECs gives favorable reviews on the proposed sites or doesn’t not respond within 2 weeks, then the study is considered approved for all sites submitted within the application.
Using https://clinicaltrials.gov our team had analyzed the trends in the clinical trials market in Poland of the first half of 2018 and is happy to share it with our readers.
Algorithm of Search at ClinicalTrials.gov. Search was performed on 04 July 2018. Advanced search option was used with all fields left blank except "Country" (="Poland") and "Start date" (="From 01/01/2018 to 06/30/2018").
Discussion on limitations of research using ClinicalTrials.gov. Search results are valid only as of the date of the search. If the Sponsor updates information on the study at a later date (e.g. next day or week post search) and adds Polish sites, then the results will differ from those that were obtained. The difference in numbers between RA approved studies and those listed in ClinicalTrials.gov is due to search limitations: 1) some approved studies are not posted on ClinicalTrials.gov; 2) "Start date" field at ClinicalTrials.gov reflects the date when the study started anywhere in the world, not specifically in Poland, so it may happen that study started in the US in 2015 (Start date = 2015) and was initiated in Poland only in 2018. In such case the search results using the algorithm described above won't identify this study. Additionally, Polish universities and companies headquartered in Poland were considered as local sponsors, others were considered as foreign sponsors.
Results for I-IIQ, 2018. During the period from 01 January 2018 to 30 June 2018, 138 clinical trials were initiated in Poland comparing to 212 and 224 in the I-IIQ of 2016 and the I-IIQ of 2017 respectively (Fig. 1). Such significant difference may be explained by publication delays at clinicaltrials.gov by the sponsor. Among 138 studies initiated in I-IIQ of 2018 only 13 (9.4%) were non-interventional and the rest (125) were interventional ones.
It must be noted that one third of all studies (46 [33,3%] trials) was initiated by local companies and universities (Fig. 2).
In 2018 only 13 (9.4%) pediatric studies were initiated, and 21 (15.2%) trials involved both adults and children. The rest of the studies (104 [75.4%]) involved adult population.
Analysis of the distribution of interventional clinical trials (N=125) by phases showed that the largest proportion was Phase III studies – 47 (37.6%) trials, followed by Phase II studies with 24 (19.2%) trials. There were 9 (7.2%) combined Phase II/III studies and 7 (5.6%) Phase IV studies initiated during this period. The number of Phase I and combined Phase I/II was small (4 [3.2%] each). Thirty (24.0%) trials listed devices, dietary supplements and procedures as its primary interventions (Fig. 3).
Clinical trials initiated in the first half of 2018 had very diverse therapeutic indications with the most common being oncology, cardiovascular diseases, dermatology, gastroenterology and endocrinology.
The largest initiated study was initiated by AstraZeneca with 13 000 participants worldwide and compared ticagrelor with placebo in patients with acute stroke or transient ischemic attack. This study is scheduled to be conducted at 33 Polish sites (409 sites globally).
There is a widespread local agreement on the value of clinical trials as it relates to Polish economy as clinical trials heavily involve other venues, including clinical laboratories, translating agencies, courier and logistics and many other services. While Poland remains the largest clinical trials market in CEE/SEE/CIS, given its population and level of healthcare services it has a tremendous potential for future growth.
Cromos Pharma will continue to publish briefs on clinical trial statistics in various countries of Eastern Europe and looks forward to your feedback. Please let us know if you find this type of information to be useful.