The number of clinical trials worldwide is increasing more than 10% each year due to the new diseases, further research for better health products and development of new drugs. Though, for a successful clinical trial, there is a major challenge – patient recruitment, which is essential and the most challenging factor due to the increasing number of new clinical trials. In order to achieve the required patient recruitment, sponsors are looking for different solutions. One of them is an exploration of new countries in emerging markets. However, emerging markets have a different problem, a risk to poor clinical trial quality. But is it actually a risk?
CIS region considered as one of the emerging clinical trials markets, where sponsors find great track record in terms of patient recruitment. However, the possibilities to ensure quality in the CIS region are in question by different stakeholders. Let’s take a closer look into the CIS region, starting the analysis with patient recruitment potential and later concentrating into the main concern – quality.
According to Clinicaltrials.gov data, there are 2 173 ongoing clinical trials in the CIS region at the moment. The population in the region is more than 271 million, it’s almost the same population as in Western and Northern Europe, taken together. Moreover, figures show that the CIS region holds 10 times larger population per ongoing clinical trial compared to the already very tight market in the US and Europe. Clinical trials density measured by dividing population per ongoing clinical trial shown in the table below.
[ngg src=”galleries” ids=”7″ display=”basic_thumbnail” override_thumbnail_settings=”1″ thumbnail_width=”950″ thumbnail_height=”950″ thumbnail_crop=”0″]As well, the centralized healthcare system is another essential factor to mention speaking about CIS countries. The centralized system makes easier to find and enrol patients more rapidly compared to other healthcare systems. Because of it, patients are referred to major hospitals, in this way, providing access to a large number of subjects for a clinical trial. In the table below, you will find some statistical data on hospital numbers and health care personnel.
[ngg src=”galleries” ids=”12″ display=”basic_thumbnail” override_thumbnail_settings=”1″ thumbnail_width=”950″ thumbnail_height=”950″ thumbnail_crop=”0″]Moreover, the high prevalence of different diseases accompanies the recruitment rate in CIS countries. In the region, rare and even orphan diseases are not so exceptional. For example, only in the Russian Federation, 114 187 tuberculosis cases were notified during 2018. Furthermore, limited access to free specialized and high-technology medical care induces patients to participate in clinical trials. These conditions and highly qualified medical personnel in the study sites make CIS countries even more desired place for sponsors. In the table below, we have listed the most prevalent diseases and the main causes of death in the CIS region.
[ngg src=”galleries” ids=”9″ display=”basic_thumbnail” override_thumbnail_settings=”1″ thumbnail_width=”950″ thumbnail_height=”950″ thumbnail_crop=”0″]
”High prevalence of different diseases accompanies the recruitment rate in CIS countries.”
[ngg src=”galleries” ids=”10″ display=”basic_thumbnail” override_thumbnail_settings=”1″ thumbnail_width=”850″ thumbnail_height=”850″ thumbnail_crop=”0″]Usually, in the CIS countries, patients have a strong relationship with their physicians, in this way providing an opportunity to have a direct contact for recruitment to sponsors, through the doctors network. Because of this reason, a patient willingness to cooperate in the clinical trial contributes to a small percentage of withdrawing. Besides, participation itself provides an opportunity for a patient to receive the most modern medical treatment for his disease. As we mentioned in the beginning, impressive recruitment figures are always followed by the concern about clinical trials quality. Further, let’s proceed with this question:
What do you need to know about patient safety and data quality in the CIS region?
Rules on the protection of clinical trial subjects in the CIS countries are laid down in local legislation based on Good Clinical Practice (GCP), which is an international ethical and scientific standard. When organizing a clinical trial in the CIS region GCP requirements must be followed for designing, conducting, recording and reporting clinical trials, as well as in EU. Generally, national standards of clinical trials in CIS countries are a direct translation of ICH-GCP guidelines. Of course, there are some minor deviations in local legislation, but with the help of a partner with local knowledge and regional presence, sponsors easily manage these alterations.
In CIS countries, implementation of ICH-GCP standards at sites is obligatory and regulated by local authorities. Therefore, investigators demonstrate a high adherence to ethical standards and quality control. It is a necessity to mention that a number of FDA and EMA inspections conducted in this region during global clinical trials demonstrated the same, if not better, results than those in the US or Western European countries.
CIS region has excellent patient recruitment potential and confirmed quality of data. These characteristics make the CIS region very interesting and desired location for clinical trial conduction. However, it is best to start the entry into the new region with a European partner with local knowledge and expertise. In this way, your project will reach the fullest potential of the CIS region advantages, and at the same time, you will have an additional guarantee regulated by the EU and international standards.
If you want to get more specified information, adjusted to your project and specific needs, contact us!
Indre Dryziene MBI, MM
Project Director, Clinical Operations