The ongoing search for the better early-stage clinical trial location: a case study on Australia and Georgia

International biotech and medtech companies are constantly searching for optimal locations for their early stage and proof-of-concept clinical trials. An example of a location that has become increasingly popular is Australia. This is in large part due to the great promotional effort of the government and Australian CROs.

The well known advantages of Australia for clinical trials include a streamlined regulatory process under the Clinical Trial Notification (CTN) scheme under which only ethics approval is necessary and a simple notification to the regulatory authority. Another advantage are the tax credits offered by the Australian government which reduces costs but requires incorporation of a corporate entity in Australia.

Clearly Australia makes a strong case; however other potential locations should not be overlooked. For example, Central and Eastern Europe (CEE) boasts many of the advantages for clinical trial conduct that can be found in Australia and also offers its own unique characteristics which are very well suited. As a result, CEE has increasingly become a popular hotspot for clinical trial conduct over the last couple of decades.

Advantages of CEE

CEE is densely populated with its encapsulated countries ranging in population. On one end of the spectrum there is Estonia with 1.3 million people and 2 million people in Latvia. On the other end of the spectrum there is Ukraine with 42 million and 38.4 million in Poland. Depending on which countries are included into the calculation or not (Russia in particular, would make a major difference with is population of over 140M people) the total population of the region is in the range of 100-300 millions of habitants.

Large and available patient populations has always been a strong point for the CEE region attracting big and small sponsors of clinical trials looking for easier access to patients.

Coupled with centralized healthcare in many CEE countries, patients tend to be pooled together in higher numbers at larger and specialist hospitals which allows for a more efficient patient enrolment process with a smaller number of sites needed to reach the recruitment targets. The average reported recruitment rate in CEE is 10.3 patients per site compared to 7.5 site in Western Europe.

For various reasons, including some economic disadvantages (although these are diminishing), both the physicians and patients in the CEE region tend to be motivated and enthusiastic about their participation in clinical trials, creating a win-win situation for the sponsors of clinical trials. Good patient retention and low drop-out rates is another important advantage.

Fast rates of patient enrolment is one of the crucial advantages when considering the fact that the no. 1 cause of delays in clinical trials is inefficient patient enrolment. According to a TUFTS analysis, 48% of investigative sites either under-enrol or fail to enrol subjects. For Phase II and Phase III trials within the Western environment, 11% of sites fail to enrol even a single patient in a clinical trial. This leads to prolonged study timelines and significant financial and human resource losses.

Centralized systems of healthcare in CEE with large hospitals and effective patient referral pathways; motivated investigators with considerable experience in conducting clinical trials; patients usually enthusiastic about clinical trials and available in large numbers – all these factors form a good basis for effective patient recruitment. When these advantages are coupled with modest costs of clinical trials, CEE becomes a very strong competitor in the global clinical trial market.

Typically, all CEE countries share the advantages discussed but, in this article, we would like to focus on one particular location that is fast becoming a very popular choice for international clinical trials – the Republic of Georgia.

Spotlight on Georgia

Georgia is located in the Caucasus region, at the cross-roads between Europe and Asia. It’s a country of 69,700km squared and with a population of nearly 4 million people. It is also only 2 hours ahead of the Central European Time-Zone. In comparison, Australia is 8 hours ahead.

Let us review the clinical trial environment in Georgia. Like in Australia, the clinical trial approval process is very streamlined. Ethics approvals are granted by independent local ethics committees with typical approval timelines not exceeding 2 weeks. Approval by the special committee on clinical trials within the Ministry of Health which is needed for clinical studies of pharmaceutical products is granted within 21 days. This makes Georgia the fastest location for clinical trial start-up timelines in Europe.

In addition, no import license is required in Georgia for the importation of investigational products. This means faster and easier study start-up; and the whole logistics process is very simple and cost-effective with no duties to pay on the imported clinical trial materials.

The cost of clinical trials is always an important consideration, particularly for smaller and mid-size sponsors. Although no tax credits are available in Georgia, the cost of clinical trials is modest and, in our estimates, the overall costs end up being significantly lower than in Australia.

The standard of the healthcare system is also of course a crucial factor. Visitors to Georgia are often very surprised by the high standard of the healthcare system. The majority of (the nearly 300) hospitals are very modern and have state of the art equipment. Many physicians received training in Western Europe and the United States and speak very good English. There are also many national key opinion leaders available who are extensively published and have participated in many international clinical trials. The two therapeutic areas that are the most popular and most advanced in Georgia for clinical trials are oncology and cardiology.

ICH GCP compliance was introduced in Georgia in 2008 and is fully integrated into national legislation. In general, it is a misconceived concern that CEE countries do not conform to the standards of data quality and GCP demonstrated in Western Europe, Northern America and Australia. Our own experience would prove the contrary, but FDA inspections– an excellent objective measure of the quality of clinical study data – prove this claim too.

On the FDA inspection database and in the figure below, you will find that Georgia has had 17 Bioresearch Monitoring FDA inspections, with 100% NAI (No Action Indicated) reports. To our knowledge, Georgia is the only country in the world to have achieved 100% NAI outcomes in FDA inspections. In comparison, 19 Bioresearch Monitoring FDA inspections have been carried out in Australia within the last decade, with 12 NAI reports and 7 VAI (Voluntary Action Indicated) reports.

The results of the FDA inspections in Georgia are impressive and credible proof that the quality of clinical trials and GCP compliance are both high and worthy of recognition. Evidence exhibits that Georgia is the new rising star location to watch for international clinical trials.

Figure 1:

In conclusion, there are multiple locations in the world competing for clinical trial business and being the top choice for early stage clinical studies. Australia is one of these competitors. More and more countries are now joining the rivalry, including Central and Eastern European countries such as the Republic of Georgia. The positive outcome of this is that there is now greater choice for biotech and medtech companies for clinical trial conduct. This leads to better and faster clinical trials and helps the growth of the entire lifescience sector.

Sources:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-classification-database

https://clinicalaccelerator.com/clinical-trials-in-georgia/

This entry was posted in Biotech, Central and Eastern Europe, ClinAccel.Net, Clinical Accelerator, FDA, Medical Devices, Patient Enrolment. Bookmark the permalink.

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