Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies To Ensure Medical Device Success in a Global Marketplace

In the face of cost and regulatory pressures, clinical programs at medical device organizations have looked to less expensive and regulated areas of the world to perform clinical trial activities. Emerging markets are also fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets. However, there are still questions around the cost, acceptability, quality and pitfalls of conducting clinical trials in emerging regions.

Best Practices®, LLC conducted primary research to inform clinical affairs leaders at medical device companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions.

Critical outsourcing questions addressed in this survey include:

• What are the regions where medical device companies are conducting clinical trials and the percent of patients recruited annually from these regions?
• Which clinical trial activities are best suited for outsourcing?
• What is the appropriate staffing mix (in-house and outsourced) for clinical trials?
• What are the most important competencies for clinical research associates, managers, and directors?

Study Snapshot

Research participants included 13 executives and managers from 11 medical device companies across a wide variety of therapeutic areas and product classes. In addition, four executive interviews were conducted to collect qualitative insights.

Key Findings

Seventy-one percent of the companies that participated in this study expect they’ll increase outsourced staffing during the next three years – and 86 percent believe the number of trials done in emerging markets will increase as well.

• While the device segment split on the cost question, they were generally satisfied with the quality of outside-U.S. trials – 85 % rated quality with either medium or high satisfaction/success (15 % were low success).