Comparative Statistical Analysis of Clinical Trials: CIS, EE and US
Clinical trials are a lengthy process in which, on average, more than 12 years pass from the development of an idea in a laboratory to product registration. Clinical studies are conducted in accordance with ethical standards, as well as with local and international regulatory requirements.
Information obtained during a clinical study allows to evaluate both the efficacy and the safety of the applied treatment. When choosing a therapy, a physician should evaluate the results of all clinical studies conducted on this type of treatment. Access to information about clinical trials is one of the most important tools of improving the effectiveness of scientific research, because it reduces duplication, and allows to evaluate all the accumulated data on the studied drug or treatment method.
There are two main resources used to obtain information about clinical trials. The first is registry of clinical trials run by United States National Library of Medicine (NLM) at the National Institutes of Health (www.clinicaltrials.gov), which contains information about research conducted around the world. The second one is the European Clinical Trials Base (EudraCT), which publishes information on ongoing and already completed clinical trials conducted within the European Union (EU) and the European Economic Area (EEA), as well as on clinical trials of drugs that have an EU registration certificate, both in the EU / EEA and beyond [Eudra CT, 2018]. However, the EudraCT database is relatively new and, although the quality of registry services is constantly improving to ensure availability of information about clinical trials, the most complete database of today is www.clinicaltrials.gov. There are local databases in countries which are not EU/EEA members, however, they often do not provide an opportunity to view information in English.
The potential of countries in the CIS region to conduct international clinical research is quite high, which is associated with a diverse population of patients, rapid recruitment of participants, and retention of patients in the study [Dombernowsky et.al., 2017]. In addition, it should be noted that changes in the legal and organizational fields for clinical research in the CIS countries made it possible to optimize both the timeframe and the procedure for obtaining approval [Volodina, 2010]. We have decided to conduct a statistical analysis of clinical trials conducted in the countries of the CIS region, as well as in countries of Eastern Europe and the USA. For information on clinical trials, it was decided to use www.clinicaltrials.gov, because it contains the most complete list of ongoing and already completed clinical studies.
In terms of the number of studies conducted, the countries of the CIS and Eastern Europe still lag far behind the United States (Fig. 1), where, according to the data for 2017, 3,974 studies are being conducted. It stands to mention that Israel, Russia and Poland occupy the leading positions in the number of studies among the countries mentioned above. Of the 152 studies being conducted in Israel, 96 are local, which seems to be associated with a large number of local biotechnology companies. Poland is the leader in the number of clinical trials conducted in Europe, which is mainly due to its large population and the relatively low cost of research in this country. Russia is also in the top tier by the number of studies, which is linked to rapid recruitment of research participants, large number of research centers, as well as a relatively low cost of research. In addition, it is worth noting that in Russia, according to the local law, approved foreign drugs must undergo additional clinical trials, which also increases the total number of trials conducted there.
Fig.1. Numbers of clinical trials conducted in CIS and in Eastern European countries
The distribution of studies by phases is shown in Fig. 2. By the number of non-interventional studies conducted in these countries, the leading positions are occupied by Israel (25 studies), Poland (13 studies), Russia (9 studies) and the Czech Republic (7 studies).