7 common concerns about clinical trials in Eastern Europe
Accell Clinical Research offer insights on some of the key sponsor concerns when considering trials in Eastern Europe and RussiaAdd bookmark
When sponsors are exploring Eastern European and CIS countries as a destination for clinical trials, we often receive a number of typical questions and concerns. In this article, Accell would like to address seven common concerns we tend to hear to aid your decision making process.
1. Lack of knowledge about clinical trials in Eastern Europe and Russia
A common concern that arises is the lack of knowledge or awareness of the procedures and standards of clinical trials in Eastern Europe and Russia.
In actuality, the essential procedures in Russia/Ukraine and Eastern Europe do not differ much from European or American trials, as national standards of clinical trials are a direct translation of ICH-GCP. There are some minor deviations present to meet regional regulations. However, your local clinical research partners should be aware of these and able to provide guidance to address these minor alterations easily
By partnering with a trustworthy CRO with local knowledge and regional presence a sponsor can avoid unnecessary confusion and operate to their full potential.
2. The data is of poor quality and the sites are below GCP standards
Implementation of ICH-GCP standards at sites is obligatory and regulated by local authorities. The relevant principle investigators are all certified, with the necessary experience and specialization to be approved.
It is noteworthy that Eastern Europe, Russia and Ukraine have attracted a number of FDA and EMA inspections during global clinical trials. Yet many of these audits show the same if not better results in Russian sites than those in the US or Western European countries. Russian research sites often demonstrate a high adherence to ethical standards. They provide adequate ICFs, an appropriate monetary compensation for volunteers, full accuracy of records and strict adherence to initial investigational plans.
This is also still a common apprehension that Eastern Europe and Russia are behind in the development and application of the latest procedures and technology. This is not the case.
As a real-life example, going through Accell’s past metrics reveals that Russian sites received a smaller number of Data Clarification Forms (DCFs) per dosed patient than the sites in the USA (88 in Russia versus 241 in USA), as well as a fewer number of Data Management (DM) queries per patient visit (1,2 in Russia vs. 2,8 in USA). In Accell’s current oncology trial, an independent auditor recently highlighted exceptional accuracy of data and precision in documentation management at the sites that we work with.
3. There is too much unfamiliar bureaucracy and red tape
Every country naturally has their own set of rules and procedures, with expected variations from country to country. Eastern Europe can be divided into nations that adhere to the European Medicines Agency (EMA) guidelines and those with their own internal standards. However, these days there are well-structured written procedures required for clinical trial initiation in each Eastern European country.
Any bureaucratic burden can be lessened from a sponsor with the help of a local clinical research partner who understand the varying systems and landscape.
4. There are too many hidden costs
When working in Eastern Europe and Russia, some sponsors worry that the project budget they receive will eventually increase following the rise of hidden costs.
However, most increases in cost are often due to a CRO’s specific manner of doing business. To win an initial bid a CRO may underprice their services or not include all expenses the sponsor will face. Extra costs may also arise due to poor planning of the full study or miscalculations.
Transparency with a CRO is a cornerstone to avoiding hidden costs. At Accell, we adhere to a transparent budgeting policy making sure all aspects are negotiated and agreed in advance with all risks disclosed and discussed. We are also open about changes which could be beyond our control, such as national legislation changes, taxation or custom fee changes. For example, VAT recently changed in Russia from 18% to 22%. By making our client aware of this in advance, we were able to ensure this did not affect the sponsor’s budget.
It is also interesting to note that rather than bringing about extra costs, running clinical trials in Eastern Europe and Russia may be more cost-efficient than running the same study in the US or Western Europe. The average per patient cost in Accell’s trial regions can be up to 30-40% lower than in the US due to regionally differentiated costs, such as investigator fees, and a high concentration of patients in therapeutically aligned medical centers.
5. Regulatory approvals in Eastern Europe take too long
The complexity of regulatory approval procedures and time to first-site initiation play a vital role in strategic country-selection decision making process.
We have heard concerns of some approvals taking up to 6 months in Eastern Europe. These extended timelines in certain regions may be a reality when a global CRO does not have the flexibility to be adaptable to the local legislation environment.
We have found that we are able to gain regulatory approvals on average within 60 days across a number of countries in Eastern Europe and Russia. Having full knowledge of the region allows us to advise on the most predictable and fastest timelines to help sponsors meet their required deadlines. It’s essential that a local CRO is aware of the countries which tend to follow their stated deadlines and where any potential ‘pitfalls’ could be so that an optimal solution is found.
6. Regulatory submissions and filing procedures are risky and complex
Regulatory submissions should not be a complicated process if you are working with a CRO with adequate regional experience. The necessary procedure and document requirements, along with the timelines and fees, can all be found through each country’s regulatory authority and Local Ethical Committee. The most crucial aspect is that a sponsor has an Investigational Medicinal Product Dossier for an Investigational Medicinal Product and a GMP certificate of manufacturer. These documents are obligatory for Clinical Trial Authorization in all countries.
There are also assumptions that the filing procedure can be risky. However, these days all procedures are clear and well-structured. Your local CRO should know the intricacies of any local regulatory authority’s demands and be able to respond swiftly to any changes.
It is recommended to have a regional partner with a local legal representative entity so certain activities can be completed. For example, in Russian law only local legal entities are capable of signing contracts directly with clinical sites in Russia. In this instance, a local partner is necessary so a Sponsor can issue power of attorney to complete the action on their behalf.
7. Importing drugs is expensive and complicated
There are always costs from importing anything new to a non-EU country from the EU or the US, from customs fees to broker services etc. However, custom fees often depend on the declared value of a product and broker service fees are usually minor given all aspects of an average clinical trial budget.
The complexity of importing really does depends on what exactly needs to be imported into a country. If a sponsor’s IMP is pills or injections, import can be quite simple and easy. When there is a need to import specific devices, custom procedures can become a bit more complicated. However, in the majority of cases, your regional partner should be able to complete adequate research and give you detailed instructions on how to proceed to minimize the cost impact.
To sum up, there may be some pre-conceived challenges about clinical research in Easter Europe and Russia. However, we hope the above addresses some of those concerns. While some are false beliefs, others can be easily surpassed with the right knowledge and experience from a reliable research partner.
There are clear advantages to exploring clinical trials in Eastern Europe, Russia and CIS such as greater access to patient pools, extremely fast recruitment speeds and lower costs per patient. If you’d like to explore the region further, Accell Clinical Research is happy to assist.