Partnerships 2010: Clinical Trial Requirements: Similarities and Differences from a Global Perspective – Managing and Executing a Trial

Panelists: Graciela Racaro, Senior Director, Global Research Operations, PAREXEL INTERNATIONAL
Jacqueline Mardell, Formerly Senior Director of Clinical Operations, METABOLEX INC
Larry Fiori, Associate Director, Clinical Trial Outsourcing & Compliance, Compliance & Quality Management, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.

While a shrinking world presents new clinical trial opportunities to sponsor companies, the challenges of conducting trials globally that are approvable by regulators can be daunting. Ever-changing country-specific requirements can slow down trials. Should these different requirements affect country selection for trials? Does a sponsor need an in-country partner to help? How can you manage vendors around the world? A panel of experts addressed these issues Tuesday afternoon.

Graciela Racaro of PAREXEL presented some critical success factors to carrying out global trials:

• Carrying out a feasibility study before country selection
• Developing a study start-up strategy that takes into account country-specific issues
• Learn local regulations and what the critical path is to getting a study approved in a country
• Developing patient recruitment and retention strategies
• Logistical concerns (time zones, language)
• Establishing expectations for monitoring quality
• Development of a risk plan and mitigations

Larry Fiel of Boehringer-Ingelheim encouraged sponsors to dig deeper when a CRO says they can manage trials in other countries. Ask questions about their facilities and staff and experience and capabilities. He also pointed out that regardless of where you’re running a study, there are three areas a sponsor must pay attention to: data integrity, patient safety and regulatory compliance. Mr. Fiel also gave some further ideas:

• Plan ahead
• Appropriate and documented qualification assessment of vendors and CROs
• Use of Quality Agreements
• Build site and trial escalation processes upfront
• Conduct interim lessons learned meetings
• Coordinate for global inspection readiness
• Have an experienced trialist in each country and consider using a regional supervisor

Jacqueline Mardell presented some case studies demonstrating some of the challenges in global clinical trials. For example, in February in Russia, there was a halt to all clinical trials due to the absence of one official in the government who could sign off on approvals. Needless to say, this caused confusion and problems for sponsors and CROs alike. In another example, the patient data collection in a developing country ground to a halt due to a lack of infrastructure or mechanisms to track PROs from a largely illiterate patient population.

The key takeaways from this discussion really centered on planning ahead, utilizing local resources and experienced partners and doing homework on country-specific regulations.