| Bogdan Nietubyc of Hesperion Ltd asks how pharma companies, biotechs and CROs can improve their clinical outsourcing processes in the CEE region and Russia
It is very well known that an increasing number of patients in global clinical trials are being recruited in the Central and Eastern European (CEE) region, Russia and Commonwealth of Independent States (CIS) countries. In large multinational studies it is common that these countries are a few months ahead of patient recruitment schedules. Many US and Western companies are initiating rescue projects in CEE and Russia, to be put into practice if the patient recruitment of their ongoing US-based or Western European trials fail to meet the requirements. The list of factors influencing high recruitment performance in CEE and Russia is very long, and includes:
- The wide availability of treatment-naïve patients
- Lack or insufficient availability of preventive medicine
- Shortage of available therapy, abundance of high quality investigational sites
- Motivation of investigators (investigator fees still represent a significant income for the physicians)
MATTERS FOR CONCERN
Everything looks very promising, and from experience we know that it is indeed worthwhile being in the region. Yet are there really only advantages for sponsors and CROs planning to go to CEE countries and Russia? Certainly not – conducting clinical trials in this enormous region also has its downsides, such as: bureaucracy; local regulations differing from those we know well in Western countries; and very slow harmonisation or delays in the implementation of EU guidelines, even in the new CEE EU-member countries. Good clinical practice (GCP) and good manufacturing practice (GMP) standards, although officially adopted and respected, have to be controlled very carefully by locally-based monitors and auditors. |
