There has been allot of talk about running clinical trials in Eastern Europe, but what are the statistics and the feasibility, I have been looking at this and have some information to share.I have had a quick look at the following areas:

• Hungary
• Poland
• Czech Republic
• Slovenia
• Slovakia
• and some Baltic states

All the above appear to be great with clear and transparent regulations implementing the EU Clinical Trials Directive. Some other states have a less transparent regulatory system although they tend to stick to the EU Clinical Trials Directive:

• Croatia
• Bulgaria
• Romania
• Serbia
• Bosnia
• Macedonia

Then there is the less stable politically and economically and transparent regions which are generally the former Soviet Union States.

There are a number of advantages of working in these regions, they have large centralised state funded hospitals, with access to advanced medical technologies and high quality educated staff. A huge number of companies have been conducting trials in the area for some time and the infrastructure is there. All this means that patient accrual can be well above the levels expected in the EU and USA, typically 2 to 4 months ahead.

Investigators have huge access to untreated patients, there is less competition for patients, and the investigators tend to be very highly qualified, and participation in a western clinical trial is a sign of merit. The high quality of staff does not end with the investigators, CRA’s tend to be pharmacists and physicians, highly educated and competent people, this is expressed in the quality of the data, which typically surpasses  Western Europe standards. The FDA has no concerns over data coming from the region, in fact the FDA experiences a lower rate of voluntary action indicated (VAI) and Official Action indicated (OAI) than in the EU and USA.

However the one key driver is often price, investigator and study expenses are typically much lower and then monitoring costs are usually on 60-70% those seen in the EU and USA. I will be looking at the region for my next clinical trial.

If you would like to discuss this in more detail or get access to my contact in the region please get in touch.

As consultants working in the area of drug development, regulatory strategy and development strategy we are often involved in these kinds of document development processes and good housekeeping is vital. eCTD is coming to us all so its best we get up to speed as early as possible.

If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com