Non-members: Click here to review a complimentary excerpt from "Clinical Affairs Excellence: Benchmarking Clinical Budgets, Staffing and Activities for Medical Device Success in a Global Marketplace"
Clinical programs at medical device organizations are increasingly looking 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, quality and pitfalls of conducting clinical trials in emerging regions.
Best Practices®, LLC conducted this study to inform clinical affairs leaders at medical device companies on benchmarks around budgets, and staffing. In addition, the study presents benchmarks and insights around the current level of clinical trials in emerging areas, the cost and quality of outside-U.S. trials, and outsourcing levels for key clinical activities.
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?
This report will inform Clinical Affairs leaders on these questions and others regarding staffing, outsourcing and managing clinical trials outside of the U.S.
- Outside-U.S. Clinical Trial Overview and Insights
- Clinical Affairs Budget and FTEs
- Clinical Affairs Presence Around the World
- Cost and Quality of Outside-U.S. Trials and Outsourcing
- Outsourcing Levels for Key Clinical Activities
SAMPLE KEY FINDINGS
- Company revenues and clinical affairs spend
- Percentage of Clinical Affairs budget dedicated for studies
- Number of FTEs in global clinical affairs organization and FTEs per $100M in revenue
- Percentage of Clinical Affairs staffing working in emerging markets (BRIC)
- Percentage mix of Clinical Affairs staffing in terms of in-house, outsourced and offshored
- Optimal mix of U.S. and outside-U.S. trial sites/volunteers to meet FDA quality standards
- Regions where conducting clinical trials and percentage of patients from each region
- Experience with cost of outside U.S. trials
- Regulatory authorities reaction to clinical data from outside-U.S. trials
- Level of satisfaction with quality of outside-U.S. trials
- Percentage of outsourcing and in-house staff used for seven key clinical activities
- Rating of outsourcing suitability for seven key clinical activities
- Device participants, on average, had 91 % of their trial patients in the U.S. & Europe. But an average of 6% of their patients were in Asia-Pacific and 2 % were in emerging markets.
- The device segment appears to lag significantly behind pharma regarding outsourcing clinical activities. While the device segment did not outsource a majority of any of the seven key clinical activities benchmarked in this study, a parallel study found that pharma companies typically outsource a majority of all of them.
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 in-depth interviews were conducted to capture innovative practices in clinical activities in emerging areas.