Cromos Pharma continues with a series of overviews of clinical trial dynamics in the geographies of its clinical operations. The first briefs covering to the Republic of Georgia and Poland can be found here.
Emerging markets (CIS/CEE/Asia-Pac) continue to attract an increasing number of clinical trials. This is clearly predicated by both lower costs and faster patient recruitment that these geographies offer. Hungary is one such market of significant importance. The key drivers of Hungarian clinical trials market are its efficient patient recruitment and high quality of study execution, which is largely a product of professionalism of local medical staff.
General information about clinical trial approval process in Hungary. Regulatory Agency/Competent Authority (RA) and Ethics Committee (EC) approval is required prior to initiation of a clinical trial of a new drug or non-CE marked medical device.
The Clinical Trial Application (CTA) should be submitted to the RA by the clinical trial sponsor or its authorized representative. Application for drug/medical device studies and also non-interventional studies are made to RA, who forwards the package to the central EC. These two reviews run in parallel.
The contract negotiation should start prior to RA submission, since the budget distribution (institution/investigator) must be submitted and approved by the central Ethics Committee. The contracts can be signed prior to RA approval, but these are only valid when the study receives the RA approval.
Using https://clinicaltrials.gov our team had analyzed the trends in clinical trials in Hungary 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 01 September 2018. Advanced search option was used with all fields left blank except "Country" (="Hungary") 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 Hungarian 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 the following 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 Hungary, so it may happen that study started in the US in 2015 (Start date = 2015) and was initiated in Hungary only in 2018. In such case the search results using the algorithm described above won't identify this study. Additionally, Hungarian universities and companies headquartered in Hungary 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, 71 clinical trials were initiated in Hungary comparing to 126 and 155 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 71 studies initiated in I-IIQ of 2018 only 3 (4.2%) were non-interventional and the rest (68) were interventional ones.
Figure 1. Clinical trials initiated in I-IIQ of 2016, 2017 and 2018.
It must be noted that less than 10% of all studies (6 [8.5%]) were initiated by local companies and universities (Fig. 2).
Figure 2. Clinical trials initiated by international and local companies and universities
In 2018 only 5 (7%) pediatric studies were initiated, and 14 (19.7%) trials involved both adults and children. The rest of the studies (52 [73.2%]) involved only adult population.
Analysis of the distribution of interventional clinical trials (N=68) by phases showed that the largest proportion was Phase III studies – 38 (55.9%) trials, followed by Phase II studies with 16 (23.5%) trials. There were 5 (7.4%) combined Phase II/III studies and there were no Phase IV studies initiated during this period. The number of Phase I and combined Phase I/II studies was small (2 and 1 [2.9% and 1.5%], respectively). (Fig. 3).
Figure 3. Distribution of interventional clinical trials by phases in I-IIQ 2018
Fifty-five (80.9%) of the 68 interventional studies were conducted with drugs, 7 (10.3%) with biologics and very few trials listed devices and procedures as its primary interventions (Fig. 4).
Figure 4. Distribution of interventional clinical trials by primary interventions in I-IIQ 2018
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 14 Hungarian sites (409 sites globally).
There is a widespread local agreement on the value of clinical trials as it relates to Hungarian economy as clinical trials heavily involve other venues, including clinical laboratories, translating agencies, courier, logistics and many other services. Hungary is ninth in the EU on the list of new clinical trial applications. Each year approximately 20,000 people participate in clinical trials, that is approximately 0.2% of the 9.8 million population. Given its size and respectable level of healthcare services Hungary’s clinical trials market has a significant 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 information useful.