The challenges of managing a global clinical trial, whether in Europe, emerging countries, or any other point on the globe, are essentially very similar, regardless of the country. The biggest challenge is to understand and leverage the local nuances and flavors upfront! A simple and systematic approach will make the decision whether to conduct your trial on a global level easier.
The three main areas to explore are:
- Patient safety
- Data integrity
- Regulatory compliance
In order to satisfy any concerns related to these three areas in the country you select for your trial, you should consider critical success factors:
- Conduct a thorough feasibility study prior to the country selection
- Clarify the standard of care for this indication, available treatments, and cost and reimbursement issues
- Evaluate the incentives of both the investigators and the patients
- Develop a start-up strategy that focuses on country-specific issues
- Understand local regulations and requirements (legal entity, approval process, reporting requirements, trial registries, import and distribution of study drug, etc.)
- Realize all logistical issues (languages, time zones, etc.)
- Evaluate the local study management team (CRO or other), staff experience and capabilities
- Develop a risk plan and mitigation
In short, one should focus on thorough upfront planning, utilizing local resources and experienced partners you can rely on that know all country specific regulations and cultural environment.